ENGLEWOOD, CO / ACCESSWIRE / October 6, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs today reported financial results for its fiscal fourth quarter 2020, for the three month period ending June 30, 2020.

Fourth Quarter Fiscal 2020 Financial Highlights

Commenting on the fourth quarter of fiscal 2020, Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated "Revenue increased exponentially in Q4 2020, to $14.9 million, compared to $1.7 million for Q4 2019. It is important to note that this was the first full quarter of revenue from the combined Aytu and Innovus businesses, along with the Cerecor assets. Turning to the bottom line, adjusted EBITDA loss was reduced to just $1.7 million for Q4 2020, compared to a $3.7 million adjusted EBITDA loss for Q4 2019. On the balance sheet, with approximately $48.3 million in cash, cash equivalents and restricted cash after paying $15 million to fully extinguish the Deerfield balloon payment previously due January 2021, we have less than $1 million of debt, and at current spending levels, we believe we have sufficient runway to reach profitability."

Mr. Disbrow continued, "Taking a closer look at the top line, both of our revenue streams, from the Consumer Health and Rx segments, performed well. On the Consumer Health side, we generated $6.9 million in revenue, an increase compared to Q3. Contributing to those results was organic growth within our core Consumer Health product lines of diabetes care, sexual wellness and bladder health. Additionally, we strengthened our e-commerce business for Consumer Health. Furthermore, our newly launched Consumer Health product, Regoxidine, an over-the-counter foam formulation of minoxidil for hair regrowth, is on track to contribute revenue in excess of seven figures in its first twelve months from launch."

Mr. Disbrow added, "On the Rx side, revenue was $7.9 million, a significant increase compared to Q3. Contributing to Rx revenue was solid contribution from the pediatric franchise. Additional value was created with Natesto gaining preferred status on Express Scripts' national formulary and the Natesto spermatogenesis study results published in the Journal of Urology, both of which we expect to drive prescription growth in the coming quarters. Organic Rx growth was fueled by a relatively balanced contribution across our key products and improved sales execution. Despite the impact COVID has had on physician office access, Q4 represented a record revenue quarter for our Rx business and significant growth over the previous quarters. This is a strong statement about our field execution and clinical value of our products, and I'm pleased to see our call levels now picking back up to near normal in the current quarter to further drive prescription growth."

Mr. Disbrow concluded, "At $14.9 million in record quarterly revenue, with a narrowed Adjusted EBITDA loss, $48.3 million of cash, cash equivalents and restricted cash on the balance sheet, the addition of the Healight opportunity for COVID-19 and future potential non-COVID-19 applications, and our addition to the Russell 2000, we have strong momentum to grow shareholder value in fiscal 2021 and onward."

Conference Call Information

The company will host a live conference call at 4:30 p.m. ET today. The conference call can be accessed by dialing either:

877-407-9124 (toll-free)

201-689-8584 (international)

The webcast will be accessible live at https://www.webcaster4.com/Webcast/Page/2142/37506 and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 37506.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The recently acquired Pediatric Portfolio includes (i) Cefaclor, a second-generation cephalosporin antibiotic suspension; (ii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iii) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This antibody test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. Aytu has also licensed the Healight Platform Technology. Healight is a pre-clinical investigational device being studied as a potential treatment for COVID-19 in severely ill, intubated patients and potentially other respiratory illnesses.

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company licensing, developing, and commercializing safe and effective consumer healthcare products designed to improve health and vitality. Innovus commercializes over twenty consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, any delays in shipment that may impact our ability to distribute the COVID-19 rapid tests, any reputational harm we may incur if there are delays in receiving the shipment of the COVID-19 rapid tests, our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests' ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 rapid tests, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufacturers of the COVID-19 rapid tests are unable to meet demand, the effects of the business combination of Aytu and the Pediatric Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Pediatric Portfolio, the ultimate timing, outcome and results of integrating the operations the Pediatric Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Non-GAAP Financial Information

This press release contains a financial measure that does not comply with U.S. generally accepted accounting principles (GAAP), Non-GAAP Adjusted EBITDA. Non-GAAP Adjusted EBITDA excludes (i) amortization, (ii) depreciation, (iii) stock-based compensation, (iv) other expenses comprising net interest expense, (v) non-cash gains and/or losses recognized in the quarter or year due to changes in the fair value of certain of Aytu's financial liabilities, such as contingent consideration, derivative warrant liability, or certain exchanges of debt, (vi) bad debt expense, (vii) impairment of certain long-lived assets; (viii) one-time transaction costs and (ix) costs associated with the Company's Healight technology. Management believes these measures are useful to supplement its GAAP financial statements with this non-GAAP information because management uses such information internally for its operating, budgeting and financial planning purposes. In addition, Aytu believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management as a basis for its financial and operational decision making. Non-GAAP information is not prepared under a comprehensive set of accounting rules and therefore, should only be read in conjunction with financial information reported under U.S. GAAP when understanding Aytu's operating performance. A reconciliation between GAAP and non-GAAP financial information is provided in the financial statement tables below.

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Statements of Operations

(Unaudited)

Three Months Ended June 30,

Revenues

Product revenue, net

License revenue, net

Total product revenue

Operating expenses

Cost of sales

Research and development

Selling, general and administrative

Selling, general and administrative - related party

Impairment of intangible assets

Amortization of intangible assets

Total operating expenses

Loss from operations

Other (expense) income

Other (expense), net

(Loss) / gain from change in fair value of contingent consideration

(Loss) on extinguishment of debt

Gain from warrant derivative liability

Total other (expense) income

Net loss

Weighted average number of shares outstanding ofcommon shares outstanding

Basic and diluted net loss per common share

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Balance Sheets

Assets

Current assets

Cash and cash equivalents

Restricted cash

Accounts receivable, net

Inventory, net

Prepaid expenses and other

Other current assets

Total current assets

Fixed assets, net

Right-of-use asset

Licensed assets, net

Patents and tradenames, net

Product technology rights, net

Deposits

Goodwill

Total long-term assets

Total assets

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Balance Sheets, Cont'd

Liabilities

Current liabilities

Accounts payable and other

Accrued liabilities

Accrued compensation

Debt

Contract liability

Current lease liability

Current portion of fixed payment arrangements

Current portion of CVR liabilities

Current portion of contingent consideration

Total current liabilities

Long-term contingent consideration, net of current portion

Long-term lease liability, net of current portion

Long-term fixed payment arrangements, net of current portion

Long-term CVR liabilities, net of current portion

Warrant derivative liability

Total liabilities

Read the original:
Aytu BioScience Announces Fiscal Q4 2020 Net Revenue of $14.9 Million, an Increase of 82% Sequentially, and 766% Year-Over-Year - BioSpace

Research recently conducted connects diminished blood concentrations of testosterone in men with more severe presentations of COVID-19.

This data completely debunks popularly brandished myths and presumptions suggesting that higher testosterone levels explained why men stood at greater risk of developing severer cases of the illness than their female counterparts.

That said, as the pandemic has progressed, data put forth by healthcare providers has concluded that men seem to develop worse cases than women.

One initial theory supporting the hypothesis that hormonal differences seen in the genders might make men more vulnerable to the pathogens most serious impacts. Researchers continued to suggest that testosterone correlates with aggressive behavior, as mens bodies contain much more testosterone than women. Early speculation centered around such factoids being the reason men seemed to fare worse.

However, newer findings might suggest that, in actuality, the opposite is true. That said, this research didnt provide any data unequivocally linking low T levels to serious cases of the COVID-19. Researchers emphasize that such outcomes could be related to other underlying factors.

That said, these same medical professionals strongly caution the efficacy and safety of clinical trials of drugs used to lower testosterone or heighten estrogen levels as therapeutic protocols for men diagnosed with COVID-19.

In a fresh study Association of Circulating Sex Hormones With Inflammation and Disease Severity in Patients With COVID-19, doctor Abhinav Diwan, who also serves as a professor of medicine at Saint Louiss Washington University School of Medicine, said that the pandemic has created a prevailing belief amongst medical community members that testosterone fuels COVIDs fire.

The physician continued that the reality is quite the opposite. On average, men who possessed diminished systemic concentrations of testosterone upon entering the hospital actually had a higher risk of developing severe COVID-related manifestations or even death than men with higher internal levels of the hormone.

Moreover, researchers found that, if men with already low testosterone levels experienced further systemic declines, their risk for significant complications rose even greater.

Study overseers examined the blood samples of 90 men and 62 women who visited the Barnes-Jewish Hospital presenting with confirmed cases. Of the 143 patients ultimately admitted, researchers again sampled their blood after 3, 7, 14, and 28 days. In addition to testosterone, researchers measured systemic levels of several other notable hormones.

Examiners found that, in women, no appreciable links between hormonal levels and disease severity could be found. Amongst men, no other substances but testosterone revealed any notable findings.

Blood concentrations of testosterone are considered low if the numbers fall below 250 nanograms per deciliter. At admission, men with serious COVID-19 presentations averaged readings of 53 nanograms per deciliter. However, men with milder cases averaged 153 nanograms per deciliter.

Moreover, the results produced by the sickest subjects continued to decline as time progressed. By their third day in the hospital, readings dropped to an average of 19 nanograms per deciliter.

Researchers emphasize that other factors are known to induce more severe illness. Such as high blood pressure, diabetes, older age, and obesity are also connected to low testosterone.

Also, they discovered that men with low T who were not terribly ill at first were more likely to require placement in intensive care or intubation in the immediate days that followed.

Such data, inspired endocrinologist and study author, Dr. Sandeep Dhindsa to confidently opine that lower T levels seemed to be a significant predicting factor in which patients would grow significantly ill.

Additionally, this team of researchers is examining if these findings might suggest links between reproductive hormones and post-Covid cardiovascular concerns. Diwan, who is a cardiologist by trade, opined that when symptoms lingered on for months after initial infection, such issues could arise.

The doctor also stated that men stricken with severe cases or lingering manifestations might benefit from testosterone therapy. For some time, this therapeutic protocol has been employed as a treatment for men coping with low T levels and experiencing the physical and emotional symptoms of said occurrence.

The study was conducted in collaboration with Washington Universitys biorepository and the academic institutions Institute of Clinical and Translational Sciences.

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How low T increase risk of severe COVID-19 in men - The Southern Maryland Chronicle

Recommendations on use of the new dual-action anabolic agent romosozumab (Evenity, Amgen)and how to safely transition between osteoporosis agents are two of the issues addressed in the latest clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis from the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE).

"This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of postmenopausal osteoporosis," the authors say.

The guidelines focus on 12 key clinical questions related to postmenopausal osteoporosis, with 52 specific recommendations, each graded according to the level of evidence.

They also include a treatment algorithm to help guide choice of therapy.

Among key updates is an emphasis on the role of the Fracture Risk Assessment Tool (FRAX) in the diagnosis of osteoporosis in patients with osteopenia.

While patients have traditionally been diagnosed with osteoporosis based on the presence of low bone mineral density (BMD) in the absence of fracture, the updated guidelines indicate that osteoporosis may be diagnosed in patients with osteopenia and an increased fracture risk using FRAX.

"The use of FRAX and osteopenia to diagnosis osteoporosis was first proposed by the National Bone Health Alliance years ago, and in the 2016 guideline, we agreed with it," Pauline M. Camacho, MD, co-chair of the guidelines task force, told Medscape Medical News.

"We reiterate in the 2020 guideline that we feel this is a valid diagnostic criteria," said Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center, Loyola University, in Maywood, Illinois.

"It makes sense because when the thresholds are met by FRAX in patients with osteopenia, treatment is recommended. Therefore, why would they not fulfill treatment criteria for diagnosing osteoporosis?"

An increased risk of fracture based on a FRAX score may also be used to determine pharmacologic therapy, as can other traditional factors such as a low T-score or a fragility fracture, the guidelines state.

Another key update is the clarification of the risk stratification of patients who are high risk versus very high risk, which is key in determining the initial choice of agents and duration of therapy.

Specifically, patients should be consideredat a very high fracture risk if they have the following criteria: a recent fracture (eg, within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (eg, long-term glucocorticoids), very low T-score (eg, less than 3.0), a high risk for falls or history of injurious falls, and a very high fracture probability by FRAX (eg, major osteoporosis fracture > 30%, hip fracture > 4.5%) or other validated fracture risk algorithm.

Meanwhile, patients should be considered at high risk if they have been diagnosed with osteoporosis but do not meet the criteria for very high fracture risk.

Another important update provides information on the role of one of the newest osteoporosis agents on the market, the anabolic drug romosozumab, a monoclonal antibody directed against sclerostin.

The drug's approval by the US Food and Drug Administration (FDA) in 2019 for postmenopausal women at high risk of fracture was based on two large trials that showed dramatic increases in bone density through modeling as well as remodeling.

Those studies specifically showed significant reductions in radiographic vertebral fractures with romosozumab compared to placebo and alendronate.

Camacho noted that romosozumab "will likely be for the very high risk group and those who have maxed out on teriparatide or abaloparatide."

Romosozumab can safely be used in patients with prior radiation exposure, the guidelines note.

Importantly, due to reports of a higher risk of serious cardiovascular events with romosozumab compared to alendronate, romosozumab comes with a black box warning that it should not be used in patients at high risk for cardiovascular events or who have had a recent myocardial infarction or stroke.

"Unfortunately, the very high risk group is often the older patients,"Camacho notes.

"The drug should not be given if there is a history of myocardial infarction or stroke in the past year," she emphasized. "Clinical judgement is needed to decide who is at risk for cardiovascular complications."

Notably, teriparatide and abaloparatide have black box warnings of their own regardingrisk for osteosarcoma.

Reflecting the evolving data on osteoporosis drug holidays, the guidelines also address the issue and the clinical challenges of switching therapies.

"In 2016, we said drug holidays are not recommended, and the treatment can be continued indefinitely, [however] in 2020, we felt that if some patients are no longer high risk, they can be transitioned off the drug," Camacho said.

For teriparatide and abaloparatide, the FDA recommends treatment be limited to no more than 2 years, and for romosozumab, 1 year.

The updated guidelines recommend that upon discontinuation of an anabolic agent (eg, abaloparatide, romosozumab, or teriparatide), a switch to therapy with an antiresorptive agent, such as denosumab or bisphosphonates, should be implemented to prevent loss of BMD and fracture efficacy.

Discontinuation of denosumab, however, can have notably negative effects. Clinical trials show rapid decreases in BMD when denosumab treatment is stopped after 2 or 8 years, as well as rapid loss of protection from vertebral fractures.

Therefore, if denosumab is going to be discontinued, there should be a proper transition to an antiresorptive agent for a limited time, such as one infusion of the bisphosphonate zoledronate.

The authors underscore that in addition to communicating the potential risk and expected benefits of osteoporosis treatments, clinicians should make sure patients fully appreciate the risk of fractures and their consequences, such as pain, disability, loss of independence, and death, when no treatment is given.

"It is incumbent on the clinician to provide this information to each patient in a manner that is fully understood, and it is equally important to learn from the patient about cultural beliefs, previous treatment experiences, fears, and concerns," they write.

And in estimating patients' fracture risk, T-score must be combined with clinical risk factors, particularly advanced age and previous fracture, and clinicians should recognize that the absolute fracture risk is more useful than a risk ratio in developing treatment plans.

"Treatment recommendations may be quite different; an early postmenopausal woman with a T-score of 2.5 has osteoporosis, although fracture risk is much lower than an 80-year-old woman with the same T-score," the authors explain.

Camacho has reported financial relationships with Amgen and Shire. Disclosures for other task force members are detailed in the guidelines.

AACE/ACE Guidelines 2020 Update. Full text

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New Osteoporosis Recommendations From AACE Help Therapy Selection - Medscape

The coronavirus that causes COVID-19 has one major advantage over us it is a new human virus. Most people have not encountered the virus before, meaning their immune system is not primed and ready to fight it. When someone gets sick with COVID-19, there is a lag in an efficient immune response, giving the virus time to do significant damage before the immune system can reign in the infection.

It essentially becomes a race between how fast your immune system can clear the virus and how quickly the virus can replicate and induce damage, Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences at AlloVir, told BioSpace.

To develop an effective treatment or vaccine for COVID-19, scientists must understand how the immune system is impacted during the disease. One type of immune cell that is particularly important in the bodys response to COVID-19 is T-cells. T-cells perform many functions, including recognizing invading viruses such as the coronavirus that causes COVID-19.

Multiple studies from Wuhan, China reported that COVID-19 patients had very low T-cell counts; the sicker the patient, the lower their T-cell count. Lower T-cell counts were correlated with poorer outcomes (including higher risk of death) and T-cells isolated from COVID-19 patients also showed signs of exhaustion.

The elderly, patients with low T-cell numbers, and patients who express exhaustion markers on their T-cells are high risk groups in which nave cell responses (responses against a virus they have never seen before) may be deficient or delayed, thus allowing the virus to induce a large amount of damage, Dr. Melian explained. These patients may, therefore, benefit from AlloVirs approach which is designed to restore natural T-cell immunity in high risk patients.

Could giving high-risk COVID-19 patients functional T-cells against the coronavirus boost their immune system and help them recover? This is the question AlloVir aims to answer.

AlloVir creates allogeneic (off-the-shelf) virus-specific T-cells designed to treat common and devastating viral-associated diseases in vulnerable patients, such as those who are immunocompromised or patients who received an organ or stem cell transplant. Now, they are expanding their anti-viral T-cell arsenal and taking aim at COVID-19.

We believe AlloVirs technology is well positioned to treat patients with COVID-19 because our technology is designed to provide SARS-CoV-2 specific T-cell immunity while leaving non-infected cells intact, Dr. Melian commented. Our virus-specific T-cell candidates have been used to treat more than 275 immunocompromised patients with life-threatening viral infections and diseases and we believe it our approach may also have promise in treating COVID-19.

Fighting viruses with T-cells in immunocompromised patients

When you get infected with a virus, your immune system responds to the foreign threat by making specific T-cells that can recognize the virus. These specific T-cells prompt your immune system to destroy any cells infected by the virus.

However, if you have a T-cell deficiency, your immune system cannot robustly protect you. This is a major problem because an otherwise innocuous virus can become a serious infection, causing complications, and possibly even be life-threatening.

That is where AlloVir comes in. They address the underlying problem the weakened immune system. A weakened immune system can be beefed up by giving patients with T-cell deficiencies off-the-shelf virus-specific T-cells (VSTs) originally taken from healthy people. This restores their natural T-cell immunity and helps their immune system fight off the viruses.

At AlloVir, we are a leading innovator in discovering and developing allogeneic, virus-specific T-cell immunotherapies, Dr. Melian said. We are now excited to be applying our capabilities in discovering and developing SARS-CoV-2 specific T-cells to join the fight in developing a COVID-19 program for patients at high risk of severe and devastating disease.

AlloVirs virus-specific T-cell platform

To create AlloVirs T-cell therapies, the target virus is first studied carefully to identify its specific antigens (unique molecules on the outside of each virus that are specific to the virus and alert the immune system). The best antigens those that induce a strong T-cell response are used to create the therapy.

Next, blood is taken from healthy donors who have been exposed to the virus of interest and T-cells are isolated from the blood. The T-cells are activated in the lab they are trained to recognize the identified viral antigens, enabling the T-cells to selectively recognize only the desired virus.

After the T-cells have learned to recognize the specific virus, they are expanded to generate multitudes of cells. Once the activated, specific T-cells are created, they can be cryopreserved and kept for a long time, making them readily available as soon as a patient needs them. The entire process, from antigen selection to donor to ready-to-go T-cell treatment, can be completed in a matter of weeks. This process can be seen in the visual below.

Source: AlloVir

Patients are matched using the companys proprietary human leukocyte antigen (HLA)-matching formula. HLAs are proteins on the surface of cells that regulate the immune system.

Our proprietary donor selection algorithm, known as Cytokin enables us to cover >95 percent of patients in our target population from cells derived from a small number of donors, Dr. Melian said. This proprietary process of prospectively manufacturing cells for off-the-shelf use enables us to study our allogeneic cell therapies in large numbers of patients that suffer from global health crises, like seasonal influenza and, as we are discussing, the COVID-19 pandemic.

These T-cells are advantageous because they are active against a single virus or multiple viruses, are not patient-specific (so they are readily available) and are a single treatment that provides lasting protection. The biggest bonus is the immediate off-the-shelf use for time-sensitive infections in vulnerable populations, added Dr. Melian.

In addition to developing their COVID-19 therapy (called ALVR109), AlloVir has two other multi-virus specific T-cell therapies in development: Viralym-M (ALVR105) and ALVR106. Both therapies focus on treating viral diseases common to stem cell and solid organ transplant patients and other vulnerable populations.

Viralym-M targets six common viruses: BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein-Barr virus (EBV, also called human herpesvirus 4), human herpesvirus 6, and JC virus (also called human polyomavirus 2). Although these viruses are widespread and infect most people, they only cause severe problems in people with weakened immune systems due to age, organ or stem cell transplant, or disease (such as diabetes or AIDS). In a Phase 2 study, 93 percent of 38 allogeneic stem cell transplant patients had a clinical response to Viralym-M treatment and functional Viralym-M cells lasted up to 12 weeks in the patients.

ALVR106 targets four common respiratory viruses: influenza, parainfluenza virus, respiratory syncytial virus (RSV), and human meta-pneumovirus (HMPV). While these viruses tend to cause mild to moderate respiratory illnesses, they can cause severe, life-threatening illness, especially in people with weakened immune systems. ALVR106 is still in preclinical development but clinical trials are expected to begin this year. Overall, AlloVir expects to have three new proof-of-concept (POC) Phase 1b/2 and three pivotal Phase 3 studies started over the next 6-18 months.

Off-the-shelf T-cells against COVID-19

While AlloVir originally designed their T-cell therapies for transplant patients, their platform can potentially be applied to any virus to create virus-specific T-cells. This versatility allowed AlloVir to pivot and create T-cells against SARS-CoV-2, the virus that causes COVID-19. This new investigational therapy, called ALVR109, is being developed as a stand-alone treatment, though it may also be incorporated into their ALVR106 respiratory virus therapy at some point in the future.

Normally, the body would make virus-specific T-cells on their own and these would clear the virus, commented Dr. Melian. We enable that process in patients who otherwise would be T-cell deficient to restore T-cell immunity by giving ex vivo expanded cells that come from patients who already have demonstrated a potent immune response and have cleared the infection.

The process of creating coronavirus-specific T-cells is the same as creating their other virus-specific T-cell therapies. First, blood is taken from people who have recovered from COVID-19 and the T-cells are isolated. Then, the cells are stimulated with viral antigens in the lab, expanded, and cryopreserved.

We purposely choose a broad range of viral antigens to stimulate the T-cells to ensure the virus cant circumvent the virus-specific T-cell therapy by mutating or developing resistance, Dr. Melian said. Working with a wide spectrum of viral activity is different than other approaches that just focus on one viral antigen.

An open-label Phase 1 trial (called BAT IT) is anticipated to start within the next few months. Initial clinical studies of ALVR109 aim to treat high-risk COVID-19 patients, such as the elderly, to prevent organ damage. Prophylaxis studies, where the T-cells could be given to high-risk or immunocompromised patients who are not currently sick with COVID-19, may be considered later.

Coronavirus-specific T-cells vs. COVID-19 convalescent plasma

You may be wondering if another treatment that uses blood from COVID-19 survivors, called convalescent plasma therapy, is similar to AlloVirs T-cell therapy. In convalescent plasma treatment, antibodies from COVID-19 survivors are isolated from their blood by separating out their plasma (the liquid part of the blood). The plasma is given to COVID-19 patients to help their immune system fight off the infection.

Although convalescent plasma and AlloVirs coronavirus-specific T-cell treatments are both derived from COVID-19 survivors blood, the two treatments are fundamentally different.

Antibodies and T-cells work in different areas of the immune system, explained Dr. Melian. Antibodies can go after viruses in circulating blood but cant necessarily see viruses in infected cells. On the other hand, T-cells are pleotropic and directly attack virally infected cells, turning off the viral factories. T-cells are interesting because it is a live therapy they can home to virally-infected cells and direct the immune system.

Dr. Melian went on to explain that T-cell approach may be more comprehensive because they can support other immune cells that work against viruses, such as B-cells that make viral-specific antibodies. T-cells can also stimulate cytokines including interferon (a group of signaling proteins the immune system uses to respond to viruses), which further activates the bodys antiviral response.

Providing virus-specific antibodies may be beneficial and protective for some viral infections, Dr. Melian added. We dont know how these antibodies affect COVID-19 patients yet, but COVID-19 has a high mortality rate despite standard of care treatment. In this respect, it is important that all viable approaches to treatment be evaluated and I am very pleased to see these therapies have entered clinical testing.

Convalescent plasma and AlloVirs coronavirus-specific T-cell therapies are not mutually exclusive, so they could even be used together.

More:
Equipping the Immune System to Fight Against COVID-19 - BioSpace

Maybe you have used a testosterone booster before, maybe you havent. But if or when you do, knowing what ingredients to look for can be helpful. Each company will have their own formulas and unique take on a testosterone booster but there are some key testosterone booster ingredients that can work to boost your low T levels. As athletes, and in particular strength athletes, having optimal testosterone levels is imperative to good performance. And when it comes to your health, this is imperative.

Having low testosterone levels can be a killer when it comes to daily life as well as training and performance. For those suffering from low T levels, you may experience things like low sex drive, loss of muscle mass, low energy and increased exhaustion, and the unfortunate fat gain. But fear not, for testosterone boosters can greatly help especially when it comes to tackling those low levels as you look to get to peak shape.

Lets take a look at testosterone boosters and check out some key ingredients to look for on the label. Knowing what to look for can give you all you need to tackle those unfortunate low levels.

Testosterone boosters essentially work to give your body that boost in raising your levels so you reach optimal capacity. Since testosterone is a vital sex hormone, it aids in many bodily functions that you cant afford to have lacking. While it is possible to boost testosterone naturally, having a supplement like a testosterone booster can give you that edge you need most so you dont suffer any deficiency.

With a wide range of benefits, testosterone boosters can increase muscle growth and strength, help burn stored fat when mixed with regular exercise, boost your sex drive and overall libido, increase vitality, among others. With the right ingredients packed into a powerful formula, all those testosterone wants and needs can be taken care of no problem.

Check out our list of the Best Testosterone Boosters for more great products!

When it comes to knowing about your testosterone boosters, the right ingredients are crucial. Here are some key and potential ingredients to look for in your testosterone boosting supplement.

A combination of aspartic acid and L-aspartate, this can release hormones in your brain that work for better testosterone production. It also increases levels of follicle-stimulating hormone and luteinizing hormone which stimulate the testes to produce more testosterone (1).

Rich in vitamins and minerals, this ancient herb can increase libido and get your performance back on track by naturally increasing testosterone with powerful compounds (2).

By combing to receptors, this will assist with raising T levels since it is a bioidentical hormone for testosterone. Through increased testosterone, this will work to boost your sex drive as well (3).

This will work for building muscle and encourage fat metabolism as well as widen your blood vessels for better blood and nutrient flow. While it may not help increase T levels directly, it can help with certain symptoms that hinder your health and performance.

Since these convert food to energy, through metabolizing fat, you can provide for more consistent testosterone production with B vitamins. With these changes, it also works to build muscle mass and strength.

By increasing nitric oxide levels, this can increase blood flow and allow the testicles to better produce more testosterone (4).

Containing L-Dopa, which increases the pleasure hormone dopamine, it will allow for better mood thus stimulating testosterone production (5).

Can reduce estrogen and increase testosterone while also promoting muscle mass and is a key ingredient for optimizing testosterone levels (6).

May lower estrogen and cortisol which can negatively impact testosterone production. It is also a good libido enhancer.

It can increase the bioavailability of testosterone and allow for more free testosterone. When taken along with vitamin D, it can increase absorption so you get the most out of this ingredient (7).

Can reduce cortisol and works as a stress reliever, thus allowing for better testosterone production (8).

Can help with managing testosterone levels by adjusting your bodies balance of testosterone and estrogen working to increase testosterone and decrease estrogen (9).

Allows your body to absorb these nutrients better so the ingredients in your supplement hit you more effectively.

As a supplement, testosterone boosters are safe to use. What to look for is the reputation of the company and what is included in the supplement. Hidden ingredients or formulas is just something to avoid with any supplement but especially one that works to aid in your health and vitality. Always read the label and if you have more concerns, talk with your doctor or an expert to see if this is the right approach for you.

As for the effectiveness of the supplement, the right product can increase your levels and you will be back on track both inside and out of the gym. A healthy diet and quality training routine are important and can work in tandem with your booster so you see those gains you want most.

Check out our list of the Best Testosterone Boosters for more great products!

Testosterone boosters are that supplement you need to get those levels elevated and tackle any deficiencies. The right ingredients with a quality formula will get you back on track and doing what you love. Dont let low T levels ruin you sex life, training, performance, and vitality, and work to get those levels where you want them. Knowing the ingredients to look for on the label will better prepare you to find the right testosterone booster so you thrive inside and out of the gym.

Let us know what you think in the comments below.Also, be sure to follow Generation Iron onFacebook, Twitter, andInstagram.

*Images courtesy of Envato

References

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A Deep Dive Into Testosterone Booster Ingredients For Optimal Health - generationiron.com

Testosterone levels unlikely to cause age-related increase in CV disease

The latest data on testosterone levels and cardiovascular (CV) risk offer both good news and just-okay news: Men with lower total testosterone concentrations were not at increased risk for myocardial infarction (MI), stroke, heart failure (HF), or major adverse CV events (MACE), although some other testosterone-based markers were linked with higher risks for some CV events.

In a cohort study of participants in the U.K. Biobank, lower total testosterone concentration (quintile 1 versus quintile 5) was not associated with incident MI (fully adjusted hazard ratio 0.89, (95% CI 0.80 to 1.00), according to Bu B. Yeap, PhD, of the University of Western Australia in Crawley, and co-authors. In quintile 1, the median testosterone concentration was 7.75 nmol/L and 223 ng/dL versus 16/73 nmol/L and 482 ng/dL for quintile 5.

The study authors also reported the following in the Annals of Internal Medicine with regard to a lack of association between lower total testostrone concentrations and:

However, Yeap and co-authors reported that [c]alculated free testosterone may be associated with risk for MACE, and that men with lower SHBG [sex hormone-binding globulin] concentrations have higher risk for MI but lower risk for IS and HF. SHBG is the major binding protein for circulating testosterone, yet few studies have assessed whether SHBG concentrations might be associated with incident CVD events, independent of testosterone, they explained.

As for lower total testosterone, the authors suggested that it may be a marker for various sociodemographic, lifestyle, and medical factors that are associated with risk for CVD events, rather than an independent risk factor for these outcomes.

But the study had several limitations, most notably its observational design; thus, causality cannot be determined. Also, serum total testosterone, SHBG, and other covariates were measured only once at baseline, according to the authors, and the U.K. Biobank population has a predominantly Anglo-Celtic ethnic background, so the results may not apply to other racial/ethnic groups. Some previous studies have reported differences among ethnic groups for age-related drops in testosterone levels.

Still, the results in 210,700 men followed for 9 yearsof whom 4.2% had an incident CV eventwere in line with previous data, such as a 2014 study of men in the Cardiovascular Health Study, a 2016 study in men ages 17 to 97 (also by Yeap and colleagues), 2019 research specifically on SHBG levels and incident CV events, and the 2020 MrOS Prospective Study.

The current findings may help some clinicians and their patients sort out the mixed messaging regarding testosterone therapy. In 2015, the FDA supported testosterone therapy, but only for men with documented low endogenous testosterone levels caused by primary or secondary hypogonadism, explained Eliseo Guallar, MD, DrPH, of Johns Hopkins University, and Di Zhao, PhD, of Johns Hopkins University Bloomberg School of Public Health, both in Baltimore in an editorial accompanying the study.

They noted that the agency warned about possible therapy-related CV adverse events and that, a few years later, an Endocrine Society clinical practice guideline recommended against starting testosterone therapy for men with chronic conditions, including uncontrolled HF, MI, or stroke within the past six months.

The results from Yeaps group provide some warning against the use of testosterone therapy for the prevention of CVD in men, Guallar and Zhao wrote, adding that the CV safety profile of the therapy remains uncertain, and careful evaluation of the individual cardiovascular risk profile is needed before initiation of testosterone therapy for any patient.

From the U.K. Biobank, Yeap and co-authors analyzed data from community-dwelling men, age 40 to 69 years (about 95% White; <4% South Asian). The age group was on the younger side, so our ndings cannot be extrapolated to older men, nor can we address whether higher testosterone concentrations might be protective in men aged 70 years or older, they pointed out.

Assay tests were done for testosterone and SHBG, and free testosterone was calculated. Cox proportional hazard regression was done for the outcomes of incident MI, strokes, HF, and MACE. All were adjusted for sociodemographic, lifestyle, and medical factors.

They reported that men with lower calculated free testosterone values had a lower incidence of MACE (HR 0.90, 95% CI 0.84 to 0.97). Also, lower SHBG concentrations were linked with:

Finally, Yeaps group calculated the cumulative five-year incidences of all the CV events in the study for U.K. Biobank male participants with total testosterone, SHBG, cFT (free testosterone calculated using the Vermeulen formula), or FTZ (free testosterone calculated using empirical equation) values at the medians of quintile 1 and quintile 5, and reported that the change in absolute risk attributable to this difference in total testosterone concentrations was small, being 0.14% or less across outcomes. Findings were similar with cFT and FTZ. A slightly larger difference of 0.19% was seen for risk for MI related to the difference in SHBG concentrations.

Whether the results will mean anything to the $15 million-plus global testosterone supplementation market remains to be seen, although theres less doubt about the impact of direct-to-consumer (DTC) marketing of such products.

A 2017 JAMA study of DTC advertising, testosterone testing, and initiation in the U.S. (2009 to 2013) found that the former was associated with substantial overall increases in testosterone testing and initiation, and that DTC adverts was tied to more initiation of testosterone without recent serum testing, contrary to treatment guidelines, according to J. Bradley Layton, PhD, of the University of North Carolina at Chapel Hill, and co-authors. A separate 2017 European Urology Focus study also found similar results, and added that [t]here is a high prevalence of misinformation [on testosterone supplementation] on Internet advertising.

In a 2020 Andrology review, Arcangelo Barbonetti, MD, PhD, of the University of LAquila, in LAquila, Italy, and co-authors advised that in pateints with late-onset hypogonadism (LOH) [c]linicians must consider the unique characteristics of each patient and make the necessary adjustments in the management of LOH in order to provide the safest and most beneficial results of testosterone therapy, and emphasized that the therapy should not be started in case of a severe chronic heart failure myocardial infarction or stroke within the last 6 months, or thrombophilia. In case of decision to treat, hypogonadal men with chronic heart failure should be followed carefully with clinical assessment and T [testosterone] and haematocrit measurements on a regular basis.

Men with lower total testosterone concentrations were not at increased risk for myocardial infarction (MI), stroke, heart failure (HF), or major adverse CV events (MACE).

Calculated free testosterone may be tied to a risk for MACE, while men with lower sex hormone-binding globulin concentrations had higher risk for MI but lower risk for ischemic stroke and HF.

Shalmali Pal, Contributing Writer, BreakingMED

The study was supported by the Western Australian Health Translation Network, the Australian Governments Medical Research Future Fund/Applied Research Translation program, and Lawley Pharmaceuticals, Western Australia/University of Western Australia.

Yeap reported support from, and/or relationships with, Western Australian Health Translation Network, the Australian Governments Medical Research Future Fund, Lawley Pharmaceuticals, and Bayer. Co-authors reported support from, and/or relationships with, Western Australian Health Translation Network, the Australian Governments Medical Research Future Fund, UK Biobank, Lawley Pharmaceuticals, Western Australia, Bayer, Bristol Myers Squibb, American Heart Association, AC Immune, AbbVie, UpToDate, GlaxoSmithKline, NIH, The Swedish Research Council, the Swedish state/Swedish government/county councils, the ALF-agreement, the Torsten Sderberg Foundation, the Novo Nordisk Foundation, the Knut and Alice Wallenberg Foundation, National Institute on Aging, Transition Therapeutics, Metro International Biotechnology, Alivegen, National Institute of Nursing Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, McGraw Hill, Aditum, OPKO, Johnson & Johnson, CSL, Merck Foundation, Galapagos/Gilead, Pfizer, Ipsen, Novartis, Novo Nordisk, and the European Academy of Andrology, as well as patents/patent applications in the field of probiotics and bone health, and the measurement of free testosterone.

Guallar reported serving as an Annals of Internal Medicine associate editor. Zhao reported no relationships relevant to the contents of this paper to disclose.

Cat ID: 358

Topic ID: 74,358,730,358,914,109,187,192,925

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Low T Not Necessarily Troublesome for the Heart - Physician's Weekly

There are many things that can cause low levels of testosterone in women, such as menopause, aging, and problems with the ovaries or the pituitary or adrenal glands. So how can you increase levels of testosterone in women?

There are some ways you can boost your level of this hormone naturally. In this article we will discuss how to raise female testosterone production, why women would want to raise their T hormone levels and what steps should be taken and which supplements help with the process.

Women produce much of their testosterone in the Ledydig cells in their ovaries. Several factors including aging and disease can decrease female testosterone production, causing weak bones and many other problems. Hypoactive sexual desire disorder, adrenal insufficiency and weight gain are other symptoms of low testosterone in women.

Thankfully, there are several things women can do to increase testosterone production.

There are two main reasons.

Supplements are an effective and quick solution to both of the above reasons.

There are dozens of T-boosting supplements on the market. Most of them are aimed at men, obviously, as men make up 90% of the market. There is no reason why women cannot use these products. The opposite is true in the weight loss market where most products are aimed at the female marketplace but this doesnt exclude men from using.

Women want to increase their testosterone levels because either they need to or they want to. The need is covered in this article in great detail, this is due to conditions (postmenopausal women, hormone replacement therapy). The other other group is women who want more testosterone if they are keen bodybuilders and want increased muscle mass.

Here are the best T boosters for each group.

TestoPrime is a naturally formulated supplement suitable for anyone over the age of 18 that suffers from testosterone deficiency.

You will have to look past the male centric web copy as the product has a larger male customer base.

TestoPrime is arguably the most effective and efficient product of its ilk. It has lots of clinical data to enforce its claims. At the bottom of the official website there are 18 points of reference to clinical studies.

This is the most suitable, most effective and safest testosterone supplement for men.

Click here to find out more on TestoPrime

Testo Max is part of the Crazy Bulk bodybuilding supplement range. It is a more edgy product that delivers top end of testosterone treatment benefits.

It is classed as a legal steroid but doesnt actually contain any steroidal substance.

If you want to gain muscle mass, strength and lose body fat then Testo Max is the supplement for you.

Click here to find out more on Testo Max

Although testosterone is the male sex hormone levels, women produce a small amount of it in their bodies as well and it plays a surprisingly important role in maintaining female good health.

Women need adequate testosterone levels to sustain bone density, support muscle growth, and maintain healthy brain function.

A few of the other roles the male sex hormone plays in a womans body include:

The things men do to improve testosterone levels and production work equally well for women. Many of the changes that raise female testosterone levels are lifestyle-related and, in addition to boosting hormone production, will help support general good health.

Research shows lifting weights can improve testosterone levels in women and men. This type of resistance training is also good for improving muscle tone and muscle mass and provides the classic beach body so many women crave. It can also help to reduce body fat.

Several studies have explored the way resistance training can influence how much testosterone women produce in their bodies. The results of one of them suggest this type of exercise may increase free testosterone levels by as much as 25 percent.

Lifting weights is not the only type of exercise that can favorably influence testosterone levels and hormone production. Many other athletic pursuits, such as running and sports, can do it too.

A lot of the studies evaluating the way exercise affects hormone production were conducted on men. However, a number of studies were women-only or had participants of both sexes.

The results of one women-only study involving treadmill activity show prolonged aerobic exercise produced short-term elevations in testosterone.

Stress can reduce testosterone in men and women so, where possible, its best to avoid people and situations that cause it.

During periods of stress, your body starts producing extra cortisol (stress hormone). High cortisol can have a lot of undesirable effects on the female body. One of the things it can do is cause irregular periods.

Your body produces cortisol from one of the same precursors it needs to manufacture testosterone. So, when the demand for cortisol increases, your body may not have enough of one of the raw ingredients that are necessary to make testosterone.

If you cannot avoid the things that cause stress, you need to control it. There are many ways you can do this but certain ones may work better for some women than they do for others.

For instance, some women like to de-stress at the gym. Others prefer to take a leisurely stroll. Yoga and mediation are also good for calming the mind. So are music, painting, and other artistic pursuits.

Its also a good idea to get plenty of sleep. Constantly trying to burn the candle at both ends increases cortisol and stress.

If you find it hard to get to sleep, a cup of chamomile tea may help. The herb ashwagandha may be doubly useful because, as well as aiding sleep, it reduces anxiety and stress.

Several nutrients have a role to play in testosterone production including B vitamins, Vitamin D, zinc, and magnesium. Eating foods that provide Omega-3 fatty acids is another good way to boost testosterone.

Some of the best testosterone-boosting foods are:

Vitamin D and zinc are often considered to be two of the most important testosterone boosting nutrients. A lot of the best testosterone boosting supplements contain one of them. Most contain both.

In addition to boosting testosterone levels, getting plenty of Vitamin D and zinc also enhances immune function. Many people take these vitamins in pill form for that reason, often combining them with Vitamin C.

Several herbs and plants provide compounds that can stimulate increased testosterone levels. The best of them are often combined in testosterone-boosting supplements but many of them, such as ashwagandha and ginseng can be purchased in concentrated form in capsules and pills.

Ashwagandha (Withania somnifera) is a popular adaptogen herb thats a mainstay of traditional Indian medicine and has now become a popular herbal supplement all over the world.

The herb appears to boost testosterone production by stimulating the release of extra luteinizing hormone (a fore-runner to testosterone). However, Ashwagandha is possibly more famous for its ability to reduce stress.

In addition to being a key player in many products that boost testosterone, Ashwagandha is often added to beauty products because its ability to support increases in collagen production helps beautify the skin from the inside out.

Most of the best supplements provide Ashwagandha as KSM 66. This is a patented extract that provides Ashwagandha in a consistently potent form.

Traditional Chinese healers hold ginseng in high regard for its versatility as a medicinal herb. The Chinese also believe ginseng is a herb that can extend life.

People living in the west are also becoming increasingly aware of the herbs curative abilities but often have greater interest in its reputation as an aphrodisiac.

People often use ginseng supplements to increase sexual desire. Some of its prowess as a libido booster appears to be due to its ability to boost testosterone but most of the studies that show this were conducted on men.

But can it do the same for women? The results from a study conducted at the University of Edinburgh suggest that it may. However, it appears women who are older may attain the greatest level of benefit.

Green tea provides potent antioxidants that help the body get rid of toxins, encourage fat loss, and may help prevent aging. These antioxidants (green tea catechins) are only present in green tea.

One of the most important catechins in green tea, epigallocatechin gallate (EGCG) also helps to maintain circulating testosterone levels by preventing it from being converted to Dihydrotestosterone (DHT).

Most women are familiar with fenugreek. Its a very popular Indian cooking herb. Some women may also have noticed fenugreek listed as an ingredient in some of their cosmetic products because its sometimes used in facial toners and cleansers and similar products that aim to provide glowing, healthy skin.

However, fenugreek is very versatile and is associated with many health benefits, some of which are probably related to its ability to raise female testosterone levels.

Pomegranate is nutritious, tasty, and very good for your health. The ellagic acid it provides cleans the arteries and helps improve circulation. This removes unnecessary strain from the heart.

Research from 2012 suggests pomegranate extracts are also good for boosting testosterone levels and, like several other natural testosterone boosting ingredients, pomegranate provides antioxidants that can help improve the look of your skin.

Women may not require as much testosterone as men do but they still need it women produce testosterone but not as much as men. It helps keep their bones strong, improves body composition, maintains libido, and supports many other aspects of physical and mental wellbeing.

It is important to be aware to not go overboard as too much testosterone can have just an impact as too little.

Unfortunately, many women struggle with low testosterone levels. Contrary to popular belief, this is not a problem that only affects men.

Fortunately, there are plenty of things women can do to increase their natural testosterone production such as avoiding stress, adopting healthier lifestyles, and placing extra focus on foods that provide testosterone-boosting nutrients. Testosterone replacement therapy is another option (with testosterone injections, pellets or patches) but this can be quite invasive. Testosterone therapy and hormone therapy can be quite costly

Certain herbs also can boost female free testosterone levels. The best ones can be purchased individually or combined in supplements that have been developed to function as natural testosterone boosters.

However, if you are suffering from low hormone levels, the best course of action may be to hit the problem from all sides.

Avoid stress where you can, get more exercise, and eat a healthy well-balanced diet that is rich in nutrients and low in sugar and saturated fats. Then, if you want to maximize the overall benefits, take a suitable testosterone boosting supplement as well. TestoPrime and Testo Max are arguably the best examples of female T-boosters.

In addition to increasing low testosterone in women, this combination of changes should help you feel and look healthier and experience an increased joie de vivre.

More:
Low Testosterone in Women - How to Increase a Woman's Low T-levels - L.A. Weekly

The opening episode of "Hawkeye" meets up with the mostly retired heroic archer operating in the uncharacteristic role of the powerless witness. Clint Barton is off the clock, having brought his kids to see a Broadway show during a holiday trip to New York City. The musical in question, "Rogers," is a ludicrous ode to Captain America highlighted by the 2012 intergalactic invasion that the Avengers thwarted.

In that showstopper tune the Avengers' super-powered members are center stage as the actor playing Steve sings their praises, and Black Widow's double ridiculously high-kicks her way across the stage. But it takes a minute to notice whether Hawkeye is being portrayed, too. He is, but at first he blends into the background.

RELATED: "Black Widow" is a triumph for Marvel fans, yet that's what makes it so infuriating

Lining up all the heroes in the "Avengers" pantheon, Hawkeye is the one most people could probably take or leave. He's also the hero whom dedicated nutballs could persuade themselves they could actually become with enough archery training, protein powder, push-ups, "low T" supplements, yams, and inspirational speeches from Joe Rogan.

An unenhanced marksman who never misses his targets and is an expert in hand-to-hand combat, Clint is a problematic fave. While he's saved the world a few times, he outright murdered a slew of criminals in his guise as the Ronin when half the universe wasn't looking.

Renner hasn't done such a bang-up job of winning widespread endearment either. Infuriating headlines like "Jeremy Renner won't stop calling Black Widow a 'slut'" or "Jeremy Renner says it's 'not my job' to help female costars get equal pay" keep popping up in answer to questions of, "Remind me, why don't we like Jeremy Renner?" The good news there is that thisproves how little time most of us spend thinking about Jeremy Renner.

Actors are not the characters they play. We know this. But some are happy to court the public's association them with the most popular of their fictional personas. Chris Evans, the actor behind the first Captain America, happily parted from Marvel while continuing to embrace the hero's nice guy reputation. It's good for his brand.

Renner approaches the whole hero business with a resounding "meh," which is his prerogative. Along the way he's been dogged by ugly allegations surrounding a custody battle with his ex-wife Sonni Pacheco, which he's either refuted or refused to comment upon, and still doesn't leave the most flattering impression.

Neither have we been trained to expect much from his solo efforts, like his very basic acid-washed jeans rock or his starring role as an organized crime "fixer" in the Paramount+ series "Mayor of Kingstown," a 2003-era brood fest that somehow time-traveled to 2021.

What does all this have to do with "Hawkeye"? Simple it explains why a show named for the least of the world's mightiest superheroes works best as an introduction to the wonderful Hailee Steinfeld and her character Kate Bishop, set up via this series to inherit Hawkeye's mantle.

That makes "Hawkeye" the latest in a trend of properties named for or associated with alpha males being reforged as a female fighter's story.In the same way that Netflix's "Master of the Universe" animated series was not, in fact, about He-Man and "Mad Max: Fury Road" stars Charlize Theron's post-apocalyptic Amazon Furiosa, "Hawkeye" introduces Steinfeld's heroine as a wealthy young woman with a vigilante's soul.

This wasn't Kate's plan, to be clear. Danger comes into her house in the present day, the same way it dropped out of the clouds in 2012 and decimated New York, where she witnesses some of the battle and Hawkeye's derring-do from the blown-out window of her family's luxury midtown apartment. She returns from her university's holiday break having destroyed a landmark while showing off her archery skills and discovers her mother Eleanor (Vera Farmiga) has become romantically involved with a snake-like jerk (Tony Dalton of "Better Call Saul," smartly here).

Kate can sense something's not right about the guy, confirmed when she tails him to a black market auction offering an array of contraband for the 1%. She gets no such hit off Clint, which she wouldn't since she's the latest in a line of women who make Hawkeye a better man.

This directly contradicts what much of the public knows or thinks it knows about Renner, a man who couldn't make it through presenting a Golden Globe without ogling and commenting upon his partner Jennifer Lopez's cleavage. Whether acting as a force lawful good or "taking out the trash" as an antihero, Clint Barton's charisma is increased by his proximity to one or both of the women in his life who could vouch for him, like his wife Laura (played by Linda Cardellini), or have, as best friend Natasha Romanoff (Scarlett Johansson) often did.

Kate continues this trend by informing Clint that he's her hero, something he views as more of a nuisance than a responsibility. Her Christmas wish is for him to help her become the superhero she's trained her whole life to be. His is to wrap up the inconvenient public resurrection of his shameful past in time to get home in time to carve the Christmas roast with his own daughter.

This erector set of a premise is made to charm, as if Marvel is asking both Renner and the public to lighten up a little by placing him in inside a Christmas-themed buddy action romp with the star of "Dickinson," a superb performer.

Want a daily wrap-up of all the news and commentary Salon has to offer? Subscribe to our morning newsletter, Crash Course.

Steinfeld deserves a better introduction than this piece of tinsel which, in its first two episodes, never transcends the rating of fine. Nevertheless, her presence and performance elevate a story into which Hawkeye has glaring downward in disappointment before eventually figuring out how to have fun again.

This scenario makes one wonder if Marvel'snoticed that when Florence Pugh's Yelena Belova received orders to assassinate Hawkeye in the "Black Widow" post-credits sequence, more than a few people were into the idea and may have been rooting for Yelena's success. (Pugh is confirmed to appear in "Hawkeye.")

To be fair, Renner and Hawkeye have their fans, otherwise he would not be toplining this show. His (likely Dockers-wearing, American pick-up driving, dog-loving) constituency still loves him for his excellent performance in "The Hurt Locker" and, remembering how well he and Taylor Sheridan worked together in 2017's "Wind River," are committed to seeing whether "Mayor of Kingstown" goes anywhere.

Next to that gloom "Hawkeye" is a sugar plum hit teasing us with the prospect that Kate can somehow help Clint shed his Grinch persona and help him to turn around what she calls his branding problem. "People want sincerity," she says while championing the cause of wearing one's heart on one's sleeve.

The man called Hawkeye may have to be reminded of that, but the audience already knows that to be true about Renner himself. He trades in an image of being rough, unvarnished and real, a guy who told Men's Health in a recent profile that he'd rather collect and restore decommissioned fire trucks than slap his name on a vanity tequila brand. "So f**k you, Ryan Reynolds or George Clooney or whoever," he tells his interviewer. "I'll come put out the fire on your agave farm."

Good one, as long as you forget Renner's role in the Great Jeremy Renner Vanity App Debacle of 2019. We very well might by the end of the six-episode run of "Hawkeye," which could shape up to be the most forgettable Marvel Cinematic Universe property since "Iron Man 3" and make Renner's Hawkeye fade into the curtains yet again. But he's an Avenger of a bygone era. As long as Renner doesn't dim Steinfeld's light we'll be fine to see him step back to let the next generation shine.

New episodes of "Hawkeye" premiere Wednesdays on Disney+.

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"Hawkeye" reminds us why Jeremy Renner's archer is the least Avenger - Salon

Studies have shown that men over the age of 65 may benefit from taking the hormone testosterone. According toDr. Mirkin.comstudies have shown that testosterone increases bone density, raises hemoglobin levels in men with anemia, and improves sexual function. Reviews were mixed on whether testosterone improved heart health, however.

According to a study published in JAMA, testosterone significantly increased plaque in the arteries that lead to the heart. However, another study found that using testosterone gel for threeyears reduced the rate of heart attacks in men by 25%.

Dr. David B. Samadhi, a board-certified urologist, a Newsmax contributor, the director of Mens Health and Urologic Oncology at St. Francis Hospital in Roselyn, New York, and the author ofThe Ultimate MANual: Dr. Samadhis Guide to Mens Health and Wellness, tells Newsmaxthat the hormone is quite often overused because of its macho man association.

Of course, testosterone is a necessary and potent chemical messenger that indeed directly influences many physiological processes in a mans body, Samadi explains. Testosterone influences mens sex drive, bone mass, fat distribution, and muscle mass and strength, among other things. What man doesnt want to look strong, muscular, and ready for sex at the drop of a hat?

But the expert warns that advertisers understand this and play upon this notion by touting unproven products.

I remember a 2014 Time magazine cover story titled, Manopause that featured aprovocative cover and delved into the clever marketing and tons of money spent into making men believe that more testosterone is their quick fix and best remedy for remaining youthful and virile.

Thats why on any given day of the year, you see or hear commercials hawking a testosterone supplement promising to bring back mens youthful vigor, says Samadi.

As a urologist and prostate cancer surgeon, my advice to men is stay away from any spa, TV ads or any nonmedical person selling supplements for low T, he says. Testing testosterone and getting an accurate measurement can be tricky since levels fluctuate during the day.Only a doctor should be checking a mans testosterone levels. Testosterone levels should be checked before 9:00 a.m. when levels are their highest. Also, two tests are necessary to check for accuracy.

Samadi says that testosterone deficiency may or may not have symptoms.

But I can tell you, men with low T are like a car thats run out of gas they may be depressed, lack energy, motivation, and self-confidence, have reduced muscle mass and increased fat mass, loss of body hair, hot flashes, fewer spontaneous erections or difficulty sustaining erections, and have little interest in sex, he adds.

For any man who does have low testosterone, the benefits of hormone replacement therapy usually outweigh the risk., advises the expert. When men are selected correctly for using this therapy, it can be very helpful. Testosterone therapy for these men can help maintain muscle mass, slow osteoporosis, boost energy and stamina, and bring back their love life. But, I stress, its critical these men must be under surveillance with their doctor. Testosterone levels must be checked regularly as one possible side effect of testosterone therapy is it could stimulate the growth of prostate cancer cells.

Men who think they have low T, should talk to their doctor, get tested, and if therapy is needed, follow-up with their doctor periodically to have testosterone levels checked making sure the therapy is not causing any health problems, says Samadhi.

2021 NewsmaxHealth. All rights reserved.

Excerpt from:
Expert Reveals Key Information That Men Need to Know About Testosterone - KMJ Now

Doctors at the University of Rome found that 28% of men with an average age of 33 who had COVID-19 said they were experiencing erectile dysfunction.

According to the Daily Mail, only 9 of the 100 men surveyed who did not have COVID-19 reported problems with sexual function. The researchers said that ED likely occurs because of inflammation caused by the virus that narrows the blood vessels leading to the genitals. This obstructs the blood flow and hinders sexual response.

Another reason why men experience ED from COVID-19 is that the virus responsible for the illness binds to ACE2 receptors in the body. That is how it gains entry to our cells.

One of the devious ways the virus gets into the body is by its spike protein binding to a receptor found at quite high concentrations not only in the lungs but also in the reproductive organs,said Dr. Channa Jayasena, a consultant in reproductive endocrinology and andrology at Hammersmith and St. Marys hospitals in London. When COVID-19 binds to these receptors, they can no longer perform in their normal function.

According to the Daily Mail, ACE2 receptors are found abundantly in the testes. Dr. Jayasena suggested that COVID-19 may also lower the testosterone levels in men who become infected. While this can present sexual issues, lower T levels also affects overall general health.

Last November, researchers at the University of Miami Miller School of Medicine said that some men with COVID-19 sufferedfrom impaired spermatogenesis,or the production of sperm, which could result in lower sperm count, according to a study they published in the World Journal of Mens Health.

According to the New York Post, the scientists examined tissue from the autopsies of 6 men who died from the COVID-19 infection and found the virus was still in their testicles. Further research found that men who had COVID-19 and went on to test negative for the virus, still had the pathogen in their testes. According to the National Library of Medicine, Chinese researchers published a study that had similar findings.

So, the patient tested negative and was asymptomatic after having COVID-19 but still showed the presence of the virus inside the testes. The finding is novel, remarkable, and certainly worthy of further exploration,said Dr. Dr. Ranjith Ramasamy, a urologist and one of the authors of the study, according to the Post. Im fairly certain, just like mumps, about 20 to 30% of men are going to have some sort of affected fertility in their future.

Another study published in The Aging Male found that men with lower testosterone levels could be at higher risk of contracting COVID-19 and that the virus itself could cause lower T levels. Mike Kirby, a former professor at the University of Hertfordshire in the U.K., and the editor of The Aging Male, said that doctors should test the testosterone levels of their male patients with COVID-19 and supplement if needed.

Kirby said that low T levels are associated with increased cardiovascular risks, type 2 diabetes, muscular weakness and depression, loss of sexual desire and fertility, according to the Daily Mail.

Dr. Jayasena suggested that the lower sex hormone levels may be temporary.

If you had severe flu, then it might take at least another several weeks for your testes to start working properly,he said, according to the Daily Mail. A mans sperm count can drop to zero during flu and it can take three months to recover fully. So I think its reasonable to suggest a similarly severe illness such as COVID-19 would do at least that.

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Men Infected With COVID-19 Have 3 Times Higher Risk of ED - KMJ Now

Erectile dysfunctions are more common than most men believe, and while they can always leave someone in an embarrassing position at an awkward time, the reasons can be benign as well. Unfortunately, not every case of unexpected ED is harmless or temporary. As we look through the common reasons behind erectile dysfunctions, it will uncover both relatively harmless, as well as a few potentially fatal conditions that can be responsible for impotence in men.

The primary action behind impotence can be identified as a lack of blood supply to the penis, which is universal in nature. The causes that can be responsible for the lack of sufficient blood supply are plenty, but the action is always the same, irrespective of the reason. This is directly related to conditions of the heart and the arteries, as it is the heart that pumps blood through arteries and sends them to the extremities via veins and blood vessels.

As a result, any heart condition or vascular condition that can constrict or slow down the flow of blood could at times be responsible for impotence. Common cardiac and arterial health issues that have been proven to cause erectile dysfunction are as follows:

As we age, we lose muscle mass and sexual potency, but the rate of loss is not equal or even similar in all men. Aside from genetics, there are also additional factors that contribute to lowered testosterone in men as young as 30. To know whether or not lowered testosterone levels are responsible for your ED, check the low T symptoms identified by Manual. If you can relate to the symptoms, then rest assured that low T is not just one of the most common causes of impotence, but it is also very treatable with appropriate steps and meds.

Consult with experts to know what sildenafil can do for you and how it should be administered to help you overcome your ED, alongside all the other associated symptoms. Testosterone is the prime male hormone, and in order for a mans body and mind to function in the way that it should, there needs to be a sufficient natural production of it. In case that cannot be achieved, external testosterone therapy might be essential for preventing impotence, hair fall, depression and several other similar symptoms.

Diabetes is a direct and acute cause for erectile dysfunction and that applies to men with both Type I and Type II diabetes. However, men suffering from Type II diabetes experience ED far more often than men with Type I diabetes. Potentially, the damage can be permanent for men with diabetes if they do not act in time to control the disease itself.

Unlike most of the other causes mentioned so far, diabetic men who did not or could not treat their condition from an early stage are likely to experience permanent nerve and blood vessel damage, leading to perpetual impotence. On the other hand, if their blood sugar is kept under control from an early stage with changes in lifestyle and medication, it is possible for men with diabetes to lead a healthy and sexually satisfying life. If you are experiencing frequent episodes of ED, it is probably a good idea to get checked for diabetes. The urgency of the situation will gain more severity in case the patient also has one or more diabetic parent/parents.

Depression is often defined as a purely psychological cause for erectile dysfunction, but it is medically incorrect to use the classification universally. Temporary depression from a genuine cause such as the death of a close family member is mostly psychological in nature. In most cases, men get over temporary and acute depression on their own, or perhaps just by talking about the cause with someone close, or even a professional. However, the same cannot be said about clinical depression, where the brain becomes incapable of producing sufficient levels of dopamine and serotonin.

Unfortunately for those suffering from clinical depression, antidepressants are often found to be directly responsible for causing impotence in men. Since this is a unique scenario where both the disease and the cure can individually and simultaneously cause erectile dysfunctions, its a very tricky situation to deal with. If clinical depression is indeed affecting you and you have been prescribed antidepressants for managing the chemical imbalance, countering the entire scenario would require a combined effort from you, your psychiatrist and your partner. The idea should be to find alternatives to SSRIs and use break periods to help lessen the pharmaceutical and psychophysical causes of impotence as best as possible.

There are two different types of stress, although they often fuel each other, making it difficult to separate one from the other. Physical stress is a result of strenuous physical activities and mental stress is a result of worry, mental trauma, anxiety, depression and the like. As mentioned, one can often be a reason for bringing about the other, but they need not always be mutually inclusive either. Both physical and mental stress is directly linked to erectile dysfunctions though.

If the body is worked to a point of extreme tiredness, it simply may not have enough physical and/or mental energy to power and hold an erection. On the other hand, mental stress creates a distraction for the brain in a negative manner, which keeps it from acting in the way that it should in presence of sexual stimuli. ED caused by physical stress can be easily recovered from with a proper diet and restful sleep, unless it has been going on for a significant while at a stretch.

When the body is being stressed continuously without the sufficient rest and nutrition it needs, that will lead to mental stress accumulation as well. When left unaddressed for a long enough period, the impotence from such cases can take a long time to heal, if at all possible. Mental stress has the same effect and it can disrupt sleep, which is absolutely crucial for the body to recover and be productive during sexual activities. In fact, both physical and mental stress can lead to low testosterone levels, which would then require professional help, as mentioned previously.

Only a doctor with the necessary expertise (endocrinologist or urologist) and experience can help patients uncover the real reason/reasons behind their ED episodes. Even if you believe that you are aware of the cause and it isnt anything to worry about too much, get yourself checked. On the other hand, if it happens only in very rare circumstances, chances are that you have nothing to worry about. Keep an eye on the frequency though, and consult a doctor immediately if the ED episodes seem to be increasing in their occurrence. Not only is that necessary to maintain healthy conjugal relationships, but medical investigations may also reveal one of the more serious causes that we already discussed.

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Erectile Dysfunction: A Look at the Most Common Causes - Feed Leader

Low T Therapy Market Report recently published by Worldwide Market Reports company focuses mostly on required solutions to the users. The study includes analysis, forecast, and revenue from 2021 to 2026. The advancement rate is evaluated dependent on insightful examination that gives credible information on the worldwide market. Imperatives and advancement points are merged together after a significant comprehension of the improvement of this market.

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The top players covered in Low T Therapy Market are: AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals

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The Low T Therapy market report has been prepared after thorough market research being conducted. It has been prepared as per Porters Five Force Model. In terms of timeline, the market takes the period between 2021-2026 into account for assessment. Apart from this, a comprehensive SWOT analysis has been provided for swift business decision making.

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Low T Therapy Market Size, Trends, Production, Demand and Profit Is Statistical Analyzed in 2021 Report: AbbVie, Endo International, Eli Lilly ...

Indianapolis is the capital city of the state of Indiana and the world-famous Indianapolis 500 car race. This thriving metropolitan area boasts more than 2 million residents and covers 368 square miles of territory. Along with car racing and a booming economy, for men in the area, the Indianapolis Low T Center is an innovative mens health clinic that offers testosterone replacement therapy (TRT) for those with hypogonadism and other hormonal imbalance issues. We work with men to find practical and effective solutions for symptoms related to low T levels and other health symptoms that might be tied to low testosterone levels. This mens clinics offers testing and treatment for allergies, diabetes, cholesterol issues and is a one-stop shop for mens annual physicals.

Men with low testosterone levels often experience a range of symptoms that include fatigue and lethargy, reduced physical desire and a limited ability to achieve an erection, redistribution of body fat and loss of muscle mass. Some men may notice diminished cognitive abilities as a result of low T levels. At the Indianapolis Low T Center, we diagnose and treat issues associated with low testosterone to help you feel your best.

If you frequently awaken during the night choking or gasping for breath, you may be suffering from a condition called sleep apnea. Loud snoring, headaches, fatigue and sleepiness during the day are often attributable to this medical condition, which may affect more than 22 million Americans. Indianapolis Low T Center offers health assessment services and testing for sleep apnea, which may include home sleep monitoring systems to determine the presence and severity of this condition. Our medical staff will work with you to design a treatment plan for your needs and your lifestyle.

Low T Sleep Center Details

If you need help with issues related to your health including having an annual physical, or with the management of certain conditions, including low T levels and sleep apnea, Low T Center of Indianapolis offers comprehensive help and treatment options for you. Schedule your health assessment online today with our team of men's healthcare providers. We are here to serve your needs now and in the future.

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Indianapolis Low T Center & Men's Clinic | Sleep Apnea ...

Low testosterone prevalence

Low testosterone (low T) affects 4 to 5 million men in the US.

Testosterone is an important hormone in the human body. But it starts to decrease each year after age 30. In some men this can be substantial. Between 19 and 39 percent of older men may have low levels of testosterone.

Older men with low T have increasingly sought testosterone replacement therapy (TRT) in recent years. TRT addresses symptoms such as low libido, poor muscle mass, and low energy.

Its not just older men that are affected by low T. Young men, even babies and children, can also have this problem.

Low levels of testosterone that are atypical of normal aging are due to other primary or secondary causes of hypogonadism. Hypogonadism in males happens when the testicles dont produce enough testosterone. Hypogonadism can start during fetal development, during puberty, or during adulthood.

If hypogonadism begins during fetal development, the primary result is impaired growth of external sex organs. Depending on when hypogonadism starts and the level of testosterone present during fetal development, a male child can develop:

Normal growth can be jeopardized if hypogonadism occurs during puberty. Problems occur with:

Later in life, insufficient testosterone can lead to other problems. Symptoms include:

Fatigue and mental fogginess are some commonly reported mental and emotional symptoms in men with low T.

9 Warning signs of low testosterone

The two basic types of hypogonadism are primary and secondary hypogonadism.

Underactive testes cause primary hypogonadism. Thats because they dont manufacture sufficient levels of testosterone for optimal growth and health. This underactivity can be caused by an inherited trait. It can also be acquired by accident or illness.

Inherited conditions include:

Types of testicle damage that can lead to primary hypogonadism include:

Secondary hypogonadism is caused by damage to the pituitary gland or hypothalamus. These parts of the brain control hormone production by the testes.

Inherited or disease conditions in this category include:

Acquired circumstances that can lead to secondary hypogonadism include:

You may be affected by primary, secondary, or a mixed hypogonadism. Mixed hypogonadism is more common with increased age. People undergoing glucocorticoid therapy can develop the condition. It also can affect people with sickle-cell disease, thalassemia, or alcoholism.

Learn more: 5 Natural testosterone boosters

If youre experiencing symptoms of low T, lifestyle changes may help to ease your symptoms.

A good first step is increasing activity levels and maintaining a healthy diet in order to reduce body fat. It can also be helpful to avoid glucocorticoid medications such as prednisone as well as opioid pain medications.

Diet right: 8 Testosterone boosting foods

If lifestyle changes dont work for you, you may need to begin testosterone replacement therapy (TRT) for treatment of low T. TRT can be very important for helping teenage males with hypogonadism experience normal masculine development. Sufficient testosterone levels help maintain health and well-being in adult males.

TRT has side effects, however, including:

A carefully formulated TRT treatment plan should avoid many of these undesirable side effects. Talk with your doctor to evaluate your options.

Options for increasing your testosterone

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Whats Causing My Low Testosterone?

A new study suggeststhe need for caution in switching from fingolimod to a B celldepleting anti-CD20 treatment such as ocrelizumab for patients with multiple sclerosis (MS).

Italian researchers report an increased risk for prolonged reductions in T-cell counts, in addition to depletion of B cells, among patients who make this switch. Such depletion could increase the risk for infection, a particular concern in the current COVID era.

The study showed that among patients who had been taking ocrelizumab, those who were switched from fingolimod had a greater risk for lymphocytopenia throughout the 12 months of follow-up compared with patients who were switched from other therapies or who had not taken other therapies.

The results were presented by Doriana Landi, MD, at the recent 8th Joint European Committee for Treatment and Research in Multiple SclerosisAmericas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

Landi is a postdoctoral researcher and clinical neurologist at the Multiple Sclerosis Clinical and Research Unit, Fondazione Policlinico Tor Vergatal, Rome, Italy.

"It has been thought that ocrelizumab and similar drugs just deplete CD20 B cells. But there is now evidence that the CD20 is also expressed on certain T-cell subtypes, and levels of these cells are also reduced by anti-CD20 drugs," she explained.

"It may be just a small effect, but we wanted to look at this with regard to starting ocrelizumab after other treatments, particularly fingolimod, which itself is associated with pronounced lymphocytopenia," she said.

This was an observational study of patients starting therapy with ocrelizumab. The patients were divided into three groups: those who had switched from fingolimod; those who had switched from other treatments (dimethyl fumarate, interferon-beta, glatiramer acetate, natalizumab, teriflunomide); and patients who were treatment naive.

Lymphocyte subtype counts (CD3+, CD4+, CD8+ and CD20+) were taken at baseline and every 6 months after treatment with ocrelizumab was initiated.

A sample of 135 patients was analyzed (37 had switched from fingolimod, 64 had switched from other drugs, and 34 were treatment naive). Median time between washout was 73 days for fingolimod and 68 days for other treatments.

Results showed that at baseline, in comparison with treatment-naive patients, those who had switched from fingolimod experienced a significant decrease in CD3+ (1204 vs 1735 cells/mm3; P = .0003), CD4+ (551 vs 997 cells/mm3; P < .0001), CD8+ (430 vs 537 cells/mm3; P = .027), and CD20+ (88 vs 191 cells/mm3; P = .021) lymphocytes.

After 6 months, the proportion of patients with CD3, CD4, and CD8 lymphocytopenia (below laboratory reference values) was significantly higher among patients who had switched from fingolimod compared to patients who had switched from other treatments or who had not taken other treatments.

At 12 months, there was a trend toward greater CD4 and CD8 lymphocytopenia compared to the other two groups. Data at 18 and 24 months have not been confirmed, owing to the limited number of available values.

There was no difference in B-cell counts among the three groups.

"We found that ocrelizumab had a small effect on reducing T cells which was similar in the three groups of patients, but patients who had previously received fingolimod were more likely to have low T-cell counts at baseline and to be lymphocytopenic at 6 months and at 12 months after ocrelizumab," Landi told Medscape Medical News.

"So the T cells don't recover on ocrelizumab, and some patients have a risk of double immunosuppression (low levels of both T and B cells)," she added. "This is relevant, as it may increase the risk of opportunistic infections."

After correcting for baseline values, the effect of ocrelizumab appeared similar in all three groups. There was a small percentage reduction in certain T cells.

"If the patients had a reasonable cell count at baseline, that probably isn't too much of an issue; they will likely stay in normal levels. But if they start with a low lymphocyte count, then even a small reduction with ocrelizumab may put them into double immunosuppression," Landi noted.

"We don't know how long this double lymphocytopenia will last. We need to follow patients longer. So far in our study, the mean follow-up is 12 months," she said.

The researchers are also monitoring infection risk but have not as yet analyzed the data.

Landi explained that fingolimod is a popular drug, but if MS is still active while a patient is taking the drug or if safety concerns arise, then treatment would normally be switched to a different therapy, and ocrelizumab is becoming one of the more commonly used options.

"In the clinical trials with ocrelizumab, few patients had been pretreated with fingolimod, so we don't have good data on that," she said.

She recommends that clinicians evaluate T-cell substrates when making this switch. "It would be a good idea to wait a bit after fingolimod discontinuation to let lymphocytes recover, but this has to be balanced by concerns over efficacy. If we wait too long, then the relapse rate may start to increase. Several studies are ongoing to evaluate this at present."

Landi points out that the risk for double immunosuppression could be more of a problem in the current COVID crisis, insofar as both T cells and B cells are involved with antiviral responses.

"We know that COVID causes a reduction in T cells even in healthy people. If patients already have a low peripheral T-cell count and they then contract COVID, this could be a problem. We need to evaluate B- and T-cell counts in patients with worse COVID outcomes to understand this better," Landi commented.

"We believe clinicians should be aware of this issue when switching from fingolimod to ocrelizumab and that this could represent an additional risk regarding COVID, so we need to be cautious."

She suggested that during the COVID-19 pandemic, it may be better for patients for whom fingolimod is being discontinued and who have very low lymphocyte counts to be switched to drugs that do not induce lymphocytopenia.

Commenting for Medscape Medical News, Robert J. Fox, MD, said: "This study is important because we have little evidence to guide how we change patients from one therapy to another."

Although in this study there was a prolonged reduction of lymphocytes in patients who were switched to ocrelizumab from fingolimod compared to other MS therapies, "it doesn't address what clinicians really want to know: are there safety concerns?" Fox, who is a staff neurologist at the Mellen Center for Multiple Sclersois, Cleveland Clinic, Cleveland, Ohio, added.

"We know that lymphocyte reduction isn't related to risk of infection with either fingolimod or dimethyl fumarate, so we still don't know if patients transitioning from other MS therapies to ocrelizumab are at higher risk of infections," Fox said.

"This study suggests a mechanism if there is an increased risk, but it's putting the cart before the horse. Is there an increased risk in the first place? At this point, I haven't seen data to suggest that there is."

Landi reports consultancies for Sanofi-Genzyme, Merck-Serono, Teva, Biogen, and Roche. Fox has disclosed no relevant financial relationships.

8th Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020: Session FC02.03, presented September 13, 2020.

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Safety Concern With Fingolimod to Ocrelizumab Switch in MS - Medscape

ONE OF THE MOST DIFFICULT ASPECTS OF LIFE IN A COVID-19 world is the uncertainty. Not only are we facing an unseen opponent that we barely understand, but none of us know, should we contract the virus, whether well be part of the group that barely registers any symptoms or if well rapidly end up in a drug-induced haze on a ventilator in the ICU. More troubling still, neither do the doctors treating us.

What if there were a way to find out? OncologistDr. Cassian Yee of MD Anderson thinks the key to unlocking this mystery may very well be pumping inside our veins.

For more than 25 years Yee has been studying the use of T-cells, a type of white blood cell called lymphocytes, in his cancer research. They are like soldiers that are trained by the bodys immune system, he says. They go to sites of disease, the battlefield, and coordinate an attack on the enemy, the virus or cancer cell. When their job is completed, they return to the barracks and keep vigilant for any further attacks.

After reading reports that noted lower levels of T-cells in patientswith severe cases ofCovid-19, specificallythose who experiencedrespiratory failure, theoncologist realized thatdeveloping a test to quicklydetermine a patients T-cellcount could go a long waytoward helping medical personnel predict which patients are more prone to experiencing the viruss most deadly symptoms, long before doctors have to get machines to start breathing for them.

Technically this kind of lab test already exists, says Yee; its just not fast or easily available (were talking expensive and bulky equipment and results that take about half a day to process), especially when time is of the essence and equipment is in short supply. So Yee teamed up withKevin McHugh andPeter Lillehoj of Rice University to create a point-of-care device that would allow medical personnel to conduct these tests quickly and cheaply, key factors that could make this item crucial for both Texas Medical Center hospitals and underserved clinics on the front lines of the outbreak.

Using a small amount of blood, the teams point-of-care device will separate the different kinds of blood cells in the sample, count the lymphocytes, and spit out a quantifiable numberideally in about 15 minutes or less. Doctors will then use this number to determine whether a Covid-19 patient is more likely to suffer poor oxygenation. If doctors know beforehand that certain patients have low T-cell numbers and are thus more prone to experiencing the symptoms, including lung deterioration, that have been shown to be fatal in some, they could start more aggressively treating those patients long before they have to be put on ventilators. Its a bit like, Can this patient go home and safely recuperate, or should they stay in the hospital because they might need the ICU? explains McHugh, who specializes in bioengineering.

There are other potential uses for this device as well. While Yee and his team dont expect their point-of-care prototype device to be ready until January 2021 at the earliest, that hasnt stopped them from considering the technologys uses beyond the current coronavirus pandemic.

Wed love to be able to eventually move this into other viral diseases, such as HIV, Yee says. Perhaps even when patients are undergoing some type of treatment for their cancer.

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Could This Device Help Save Covid-19 Patients Before the ICU? - Houstonia Magazine

Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

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Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/599574/Aytu-BioScience-Announces-Regulatory-Approval-of-ZolpiMistR-by-Australian-Therapeutic-Goods-Administration

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Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - Yahoo Finance

Delivery of Investigational Endotracheal Ultraviolet-A Light Catheter Devices Enables Near-Term Initiation of Planned Clinical Studies in Severely Ill COVID-19 Patients

ENGLEWOOD, CO / ACCESSWIRE / August 17, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the delivery of Healight investigational devices. The delivery of these pilot scale Healight devices, designed and developed by Sterling Medical Devices ("Sterling"), enables the initiation of COVID-19 investigational clinical studies, which are expected to begin in the near-term.

Since Aytu signed a master services agreement with Sterling in April for Healight, the Company, Sterling, and its collaborators have sourced Healight device components and finalized design of the investigational devices for use in upcoming clinical studies.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "A significant amount of work has gone into the development of the Healight investigational device, and we thank all of our collaborators for their efforts. We are looking forward to taking the next steps and advancing Healight as quickly as possible. As the COVID-19 pandemic continues, the investigation and development of novel potential therapies remains a high priority for numerous companies, and Aytu is proud to be part of this important effort. If Healight demonstrates safety and effectiveness in upcoming, planned studies, we are hopeful it can become an important tool in the COVID-19 fight."

The Healight technology platform employs proprietary methods of administering intermittent ultraviolet (UV) A light via a novel respiratory tract device. Pre-clinical findings indicate the technology's significant impact on reducing a wide range of viral and bacterial loads, including the coronavirus HCoV-229E. Recently published pre-clinical data have been the basis of discussions with the FDA for a path to enable human use for the potential treatment of SARS-CoV-2 in intubated patients in the intensive care unit (ICU). Beyond the initial pursuit of a potential SARS-CoV-2 ICU indication, additional experimental studies of mixed infection suggest broader potential clinical applications for the technology across a range of viral and bacterial pathogens. This may include nosocomial bacteria implicated in ventilator-associated pneumonia (VAP).

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

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Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about

About Sterling Medical Devices

Founded in 1998, Sterling Medical Devices (SMD), specializes in the product design and engineering of medical devices for the healthcare industry. Dedicated to resolving their clients' medical device design and engineering challenges, SMD addresses the whole development process, including, product design and human factors, systems, software, electronics, mechanical, quality, compliance, and global regulatory submissions. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory registrations, clearances, and/or approvals of Class I, II, and III devices. To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients. SMD is internationally recognized and is FDA QSR 21 CFR Part 820 and Part 11 compliant, ISO 13485 registered, and IEC 62304, ISO 14971, IEC 60601, and IEC 62366 compliant. For more information, please visit http://www.sterlingmedicaldevices.com or call 201.227.7569 x2.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, manufacturing, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/601817/Aytu-BioScience-Announces-Manufacture-and-Delivery-of-HealightTM-Devices-for-Use-in-COVID-19-Clinical-Study

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Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study - Yahoo Finance

The hormone testosterone (called T for short in medical circles) has long been associated with the male physique, athleticism, and a heightened sex drive. But now, theres an idea making the internet search rounds that testosterone therapy may be the secret sauce to revamping a womans shuttered sex drive.

Even health-conscious celebrities have gotten in on the hype. In 2011, Jane Fonda told The Sunday Telegraph that she started taking the hormone in her 70s to boost her sex drive. But before you run to your doctor to ask for a prescription, you should know that testosterone therapy is a controversial approach that is not FDA-regulated for women at this time. Despite its mythical reputation, this hormone isnt a cure-all for sexual dysfunction, and it could even be dangerous for your health if not taken carefully. Let us explain.

Testosterone may be known as a male hormone, but womens bodies naturally produce it, too. Its one of many hormones that work together to control our mood, metabolism, sexual desire, bone and muscle growth, and reproductive system. As you age, your hormone levels change, with one of the biggest shifts occurring during menopause when your menstrual cycle stops for good. Menopause causes your estrogen and progesterone levels to decrease, but interestingly, it is not associated with a sudden decrease in testosterone, according to the North American Menopause Society.

That said, there is evidence that testosterone decreases throughout your life. Testosterone drops with age more than with menopause, says Margaret Wierman, M.D., professor at the University of Colorado Anschutz Medical Campus in Aurora, CO and former Vice President of Clinical Sciences at the Endocrine Society. This may explain why testosterone pills, gels, and patches are sometimes touted by drug marketing campaigns (and celebs) as a sex drive booster for older men and women whose testosterone is naturally lower than it used to be.

The problem with this approach, according to Chrisandra Shufelt, M.D., associate director of the Barbra Streisand Womens Heart Center at the Cedars-Sinai Smidt Heart Institute in Los Angeles, CA, is that testosterone is not necessarily the miracle drug you may be reading about on the internet. If you search online, it seems like testosterone could be the panacea of all hormones, relieving everything from fatigue to weight gain to depression, Dr. Shufelt says. But interestingly, she notes, there is no scientifically proven list of symptoms directly correlated to low T in women. Everyones hormone levels are naturally different, and what looks low on a testosterone test for one woman may be a perfectly normal T level for another.

To some extent, yesbut its not the end all, be all. Dr. Wierman explains that there are many different causes of sexual dysfunction (the term for when youre no longer craving or enjoying sex). There are mechanical hardware causes, there are relationship causes, there are mood causes, she says. There are rarely hormonal causes, and [in those cases] it's usually estrogen deficiency that is causing abnormalities.

Testosterone products are supplemental versions of the hormone that people take to increase their existing T levels. They come as a patch, gel, pill, tablet, or injection. Prescription testosterone products are FDA-approved for men whose bodies cannot produce adequate testosterone, due to genetic conditions like Klinefelter syndrome or damage from infection or chemotherapy. Testosterone products are notwe repeat, not!approved for people whose testosterone is decreasing with age.

Nevertheless, this hasnt stopped people from taking T (and doctors from prescribing T) for reasons other than it is officially intended. This practice has become so widespread, in fact, that the FDA issued a safety announcement in March 2015 urging doctors not to prescribe testosterone to anyone other than men with testosterone-lowering medical conditions. The statement noted that testosterone therapy could possibly increase your risk of cardiovascular problems or stroke.

For women, the risks of testosterone therapy are even less clear. What we know about safety and what has been studied in women is the short-term effects, up to two years, Dr. Shufelt says. Longer effects are not known, and we do not know the effects in women who have risk factors for heart disease and breast cancer. She stresses that longer-term studies will be necessary to determine whether low-dose testosterone therapy has detrimental effects on a womans body.

When testosterone is taken in excess quantities, Dr. Shufelt explains, it can lead to some pretty severe medical issues for women. Too much testosterone in women can result in deepening of voice, hair loss, acne, anger, and negative changes to the cholesterol panel, she says. Dr. Wierman remembers seeing a perimenopausal patient who had been given testosterone pellets at an anti-aging clinic. The high levels of T caused an increase in bad cholesterol, increase in blood pressure, excessive body hair growth, and loss of scalp hair.

In September 2019, the Endocrine Society, International Menopause Society, European Menopause and Andropause Society, and others got together to publish a global consensus statement on the safety and efficacy of testosterone therapy for women. Dr. Wierman, one of the principal authors, explains the major takeaway: testosterone therapy has only proven to be useful for one specific subset of womenpost-menopausal women with hypoactive sexual desire disorder.

Hypoactive sexual desire disorder (HSDD) is characterized by an absence of sexual desire, to an extent that it causes emotional distress and relationship problems for a couple. HSDD can be caused by a variety of factors, from medication use and chronic health conditions, to chemical imbalances and hormone deficiencies. It is diagnosed by a healthcare provider using a questionnaire and treated with anything from counseling to hormone replacement therapy, depending on the situation.

Dr. Wierman says that for post-menopausal women with HSDD, controlled studies showed that getting high physiologic doses [of testosterone] increased satisfying sexual relations by one per month, with some other potentially good effects on sexual function, such as arousal and ability to orgasm. The consensus statement specified that these doses should mimic not exceed natural levels of testosterone in premenopausal women. The statement authors urged that more research be done on testosterone therapy for women, and that testosterone products for HSDD should be created specifically with women in mind.

If youre curious about testosterone therapy and wondering if you fit into the subset of women who may benefit, Dr. Wierman suggests talking to your regular womens healthcare provider. I think that most providers, whether theyre gynecologists or endocrinologists or primary care doctors who specialize in menopausal women, can discuss the issues related to testosterone pros and cons, she says.

But before you walk away with a prescription, keep in mind that your low sex drive may not have to do with your hormones. The first thing when someone has abnormalities in their sexual function is to discuss all the different other causes of it, and try to be a detective, Dr. Wierman says. If she is having painful intercourse, maybe it's local vaginal estrogen she needs. If theres stress in the relationship, maybe therapy is what they need. Testosterone therapy is one option to increase libido, but its certainly not a foolproof key to amazing sex. And unless youre a postmenopausal woman with HSDD, you probably want to steer clear.

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Is Testosterone Therapy Safe for Women? - HealthCentral.com

Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience , Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com:https://www.accesswire.com/599574/Aytu-BioScience-Announces-Regulatory-Approval-of-ZolpiMistR-by-Australian-Therapeutic-Goods-Administration

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Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - BioSpace