Category Archives: Alternative Medicine

Complementary and Alternative Medicine Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis. It also provides market information in terms of development and its capacities.

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Some of the Top companies Influencing in this Market includes:

Columbia Nutritional, Herb Pharm, Herbal Hills, Helio USA, Deepure Plus, Nordic Naturals, Pure encapsulations, Iyengar Yoga Institute, John Schumachers Unity Woods Yoga Center, Yoga Tree, The Healing Company, Quantum Touch.

Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Complementary and Alternative Medicine market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Complementary and Alternative Medicine markets trajectory between forecast periods.

Global Complementary and Alternative Medicine Market research report offers:

Global Complementary and Alternative Medicine Market Segmentation:

Market Segmentation: By Type

BotanicalsAcupunctureMind, Body, and YogaMagnetic Intervention

Market Segmentation: By Application

Direct ContactE-trainingDistance Correspondence

Geographic analysis:

The global Complementary and Alternative Medicine market has been spread across North America, Europe, Asia-Pacific, the Middle East and Africa, and the rest of the world.

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The cost analysis of the Global Complementary and Alternative Medicine Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

Key questions answered in the report include:

Table of Content (TOC)

Global Complementary and Alternative Medicine Market Report 2021 Growth, Trend and Forecast to 2028

Chapter 1 Complementary and Alternative Medicine Market Overview

Chapter 2 Global Economic Impact on Complementary and Alternative Medicine Industry

Chapter 3 Global Complementary and Alternative Medicine Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region (2014-2020)

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions (2014-2020)

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Complementary and Alternative Medicine Market Forecast (2021-2028)

Chapter 13 Appendix

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Future Highlighting Report on Complementary and Alternative Medicine Market by 2028 | Columbia Nutritional, Herb Pharm, Herbal Hills The Host - The...

DURHAM, N.C., Oct. 29, 2021 (GLOBE NEWSWIRE) -- Bioventus (Nasdaq: BVS) (Bioventus or the Company), a global leader in innovations for active healing, has completed the acquisition of Misonix Incorporated(Misonix), a provider of minimally invasive therapeutic ultrasonic technologies and regenerative medicine that are designed to enhance clinical outcomes, for cash and common stock. Pursuant to the terms of the merger agreement, Misonix has become a wholly owned subsidiary of Bioventus.

As of the effective time of the transaction, Misonix stockholders have the right to receive either (i) 1.6839 shares of Bioventus class A common stock or (ii) $28.00 in cash, without interest, for each share of Misonix common stock they hold, subject to proration based on an aggregate maximum cash amount payable by Bioventus equal to $10.50 per share of Misonix common stock outstanding shortly prior to the completion of the transaction.

The completed transaction creates a high growth medical device company that will conduct business as Bioventus Inc. With a $15B total addressable market and the ability to gain significant market share across multiple surgical applications as well as wound healing the combined organization can deliver consistent double digit revenue growth. The acquisition is directly aligned with Bioventus mission of delivering innovations for active healing to patients and providers. The deal also furthers the Companys strategy of accelerated revenue growth through acquisitions that leverage the Companys existing infrastructure. Together the Company will have a significant sales force focused across surgical applications in spinal fusion, neurosurgery of the cranium and wound treatments including diabetic foot ulcers.

The commercial reach of the new Bioventus is significantly broader, deeper and even more global. The acquisition has significant revenue growth opportunities via sales call point synergies that we share with Misonix including spinal and lower extremity surgeons. We expect it will accelerate the adoption of the recently launched neXus platform used to facilitate ultrasonic procedures across spinal decompressions using the BoneScalpel, SonaStar for tumor ablation in the cranium and SonicOne for tissue debridement in chronic wounds. Leading wound products including TheraSkin will now be available to the entire customer continuum from the office to the wound centers, said Ken Reali, CEO, Bioventus. The combination with Misonix allows us to go deeper with our customer base leveraging our infrastructure and benefiting patients, physicians, surgeons as well as our more than 1,200 employees worldwide.

Governance Stavros Vizirgianakis and Patrick Beyer, each of whom were members of Misonixs Board of Directors, have joined the Bioventus Board of Directors as of the closing of the transaction.

About BioventusBioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit http://www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo, are registered trademarks of Bioventus LLC. BoneScalpel, SonaStar, SonicOne and neXus are registered trademarks of Misonix, Inc. TheraSkin is a registered trademark of Soluble Systems, LLC.

Forward-Looking Statements This press release contains 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, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning Bioventuss future growth and strategy and the benefits of the Misonix acquisition. In some cases, you can identify forward-looking statements by terminology such as aim, anticipate, assume, believe, contemplate, continue, could, due, estimate, expect, goal, intend, may, objective, plan, predict, potential, positioned, seek, should, target, will, would and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (HA) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (FDA); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to recognize the benefits of our investments; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner, including the Misonix acquisition; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Companys public filings with the Securities and Exchange Commission (SEC), including Bioventuss Annual Report on Form 10-K for the period ended December 31, 2020, as updated by Bioventuss Quarterly Report on Form 10-Q for the period ended July 3, 2021 and as such factors may be updated from time to time in Bioventus other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov and the Investor Relations page of Bioventus website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Companys business.

Media Contact:Thomas HillBioventus919-474-6715thomas.hill@bioventus.com

Investor Inquiries:Dave CrawfordBioventus919-474-6787dave.crawford@bioventus.com

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Bioventus Completes the Acquisition of Misonix - BioSpace

The Britishers, arguably left a decent health care delivery frame work when they left. Over the years, a lot of progress has been made in health services in Kashmir. In this connection, of late many new medical colleges in some districts of Kashmir province have come up. Prestigious Sheri Kashmir Institute of Medical Sciences at Soura, now deemed university is already functioning dedicatedly from 1982 and providing excellent patient care service to the community. The womens exclusive hospital, Lalded, is getting hundreds of new admission on daily basis. Children's hospital at Sonwar Srinagar, is offering excellent patients care. Government psychiatric hospital housed in barracks of the central jail Srinagar at Botraj colony, Badamwari, Srinagar, is doing commendable job for treating mentally sick patients. Doctors at Bone & Joint hospital, Barzalla, Srinagar are operating and treating patients with bullet and spinal injuries, day in and day out. There are so many other colleges that have come up in both private and public sector, like Government Dental College at Shereen Bagh, Kaksari, Srinagar that was established in the year 1985-86. Two government recognized colleges of Indian system of medicine are offering five year courses to students wanting to pursue alternative medicine. A nursing college and few paramedical colleges have also come up. There is no doubt that we still have a long way to go before we can assure quality health to our people.

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Healthcare as a Mission - Greater Kashmir

If a doctor told you there was a 30 per cent chance that exercise could fix your back pain, you might be pessimistic about your chances of recovery. But those are the odds relied on by millions of couples struggling to conceive, to fulfil their dreams of starting a family through IVF.

There are few areas of medicine where the final outcome is as important as it would be for IVF patients, says fertility expert ProfessorLuciano Nardo, the founder of NOW-fertility. Having a chance of less than 50 per cent to have a baby is seen as acceptable. Technically, there is NHS support available for fertility treatment but it is becoming harder to access.

The proportion of NHS-funded IVF treatments fell from 40 per cent to 32 per cent in England between 2014 and 2019, latest data from the Human Fertilisation and Embryology Authority (HFEA) shows.

In Wales, the fall was 42 per cent to 39 per cent in the same period. In Northern Ireland, 50 per cent of cycles were funded in 2014. In 2019, the rate was 34 per cent. Only Scotland recorded a rise, from 58 per cent to 62 per cent for 2014 to 2019.

The British Pregnancy Advisory Service blames this decline on a postcode lottery as local Clinical Commissioning Groups, which approve NHS IVF treatment funding, make their own interpretations of guidance from the National Institute for Health and Care Excellence (NICE). This means some women are refused treatment, even if eligible under NICE guidelines, because of the CCG policy where they live.

An extra barrier results from NICE guidance that requires lesbian couples and single women to have had six failed rounds of self-funded artificial insemination. Instagram influencers Whitney and Megan Bacon-Evans, campaigning for fairer fertility treatment for same-sex partners, highlight that most heterosexual couples qualify after two years of unprotected sex. Albeit a long time, this has no additional cost, they say.

Gay men are mostly unable to get NHS support for fertility issues and, as with straight couples, cannot get state funding for surrogacy, except in Scotland.

NICE recommends that women under 40 should be offered three cycles of IVF treatment if they have been trying to get pregnant for two years. This falls to one cycle for women aged 40 to 42. CCGs may have their own criteria, such as an age range, or if you already have children, and your weight. Fertility Network UK (fertilitynetworkuk.org) has a list of the eligibility criteria of CCGs in England and their equivalents in Scotland, Wales and Northern Ireland, but it is best to check locally with your GP and relevant commissioning group.

IVF clinics are regulated and licensed by the HFEA. There are 120 in the UK that provide IVF and other fertility treatments; 71 are mainly private and 49 provide NHS support, although the HFEA says many do both. Search for clinics, check their success rates and the treatments they offer at hfea.gov.uk. You dont need to go through the NHS and can self-fund if support isnt available or you dont want to wait for appointments. There is, however, no regulation on prices.

Fertility Network UK says the headline figures quoted on fertility clinic websites are often far lower than the eventual cost, as they may not include drugs or follow-up appointments. Self-funders cant get any state support but some clinics may offer refunds if you arent pregnant after a certain number of cycles.

There are also organisations such as Access Fertility which assesses patients and partners with clinics to offer fixed-price treatments and refunds if you dont have a baby. It is worth checking if this means paying more per cycle. Success rates and costs are important when comparing clinics but patients should also check the emotional support on offer. All clinics are supposed to offer counselling but it is worth finding reviews to find out more.

Professor Nardo predicts that IVF could get cheaper in the future as clinics make better use of artificial intelligence and machine learning. These tools are already used in labs when assessing embryos but once clinics start using it to build and spot anonymised trends among patients, it could be easier to define treatments, which could bring the cost down.

There are also firms offering alternatives, such as Ba Fertility. It is producing medically approved fertility and artificial insemination testing kits that can be used at home, for 300. The ongoing risk for couples is how long they can afford to wait both emotionally and financially.

The Competition and Markets Authority (CMA) expressed concerns earlier this year about patients being been unable to compare prices and facing unfair additional costs they didnt expect among private IVF clinics.

In one example, 87 clinics were last year found to be charging up to 800 extra for treatments such as assisted hatching and time-lapse imaging, despite the HFEA saying there is no evidence that this improves successrates. The CMA is due to review how clinics are complying with rules on making costs and success rates clear and fair from December.

Dr Ippokratis Sarris, a consultant at London clinic Kings Fertility, says most clinics are aware of the importance of showing accurate success rates but warns that the same rules should apply to unregulated alternative therapies, such as taking nutrients, so that unsubstantiated claims are not made. Fertility treatment is an emotional and complex journey, and patients should not feel at any point that they are exploited or misled, he says.

This is not just about upfront clarity in costs but also about ensuring an honest portrayal of the evidence of efficacy behind any fertility treatment claim.

Originally posted here:

IVF: How NHS funding for fertility treatment is becoming harder to access in the UK - iNews

The World Health Organization (The World Health Organization) defines alternative or complementary medicine as a health care practice It is not part of the traditions or traditional medicine of a particular country, and it is not fully integrated into the mainstream health system. In some countries, like ours, they are used interchangeably with traditional medicine.

Based on the definition of the World Health Organization, Federal Health Secretariat He identifies the four areas of greatest presence:

Although there are many studies on alternative medicine in the world, its effect on the health of the population is still unknown. Many clinicians incorporate knowledge about these practices into their training, with the goal of instructing patients about the effects of some.

In Zacatecas, one of the most responsive areas in this area was UAZ Alternative Medicine Clinic, where one of the most requested services was physical therapy, followed by acupuncture and ozone therapy.

Following the same line, only in the area that includes the Metropolitan Municipality and its neighbor Guadalupe, there are a series of clinics, centers and health food stores dedicated to alternative medicine. The areas in which they work are the following:

It is important to remember that some of these practices do not have medical support, so the responsibility lies with those who go to them.

Award-winning zombie scholar. Music practitioner. Food expert. Troublemaker.

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Alternative medicine, over a trend in Zacatecas - Sunday Vision

In the post-corona world, if there is a sector with a massive boom ahead, it is of alternative medicines. And as India is home to one of the oldest and highly advanced curative traditions in form of Ayurveda, it is a great opportunity that India can capitalize on, provided we have right policies in place at the earliest that will allow Ayurveda to fill the vacuum that allopathy is leaving behind.

If we dont act soon, greedy market forces will take Ayurveda on the same path that allopathy has gone, i.e., abject commercialization sans social values.The biggest stumbling block ahead for Ayurvedic medicines is to get legal recognition in a world where allopathic drug laws rule the roost.

As allopathic medicines pass through a process of clinical trails to get empirical confirmation for safe consumption and efficacy, the simple regulatory solution is to push Ayurvedic medicines on the same route for approval. The biggest advantage of taking such a regulatory route is that it will allow Ayurvedic medicines to access global market and if we play our IPR game properly, Indian manufacturers can enjoy the massive valuation that western drug companies have been thriving on.

The problem with allopathy-like validation for Ayurvedic medicines is that the curative logic and processes of Ayurveda are not exactly like allopathy where very direct cause-and-effect relationships are immediately visible in all medications. A lot of Ayurvedic medicines target chronic diseases and offer long-term benefits that a conventional clinical trial-based process will not be able to register or confirm. This means that establishing efficacy under the current for-allopathy framework will not be easy for all Ayurvedic medicines.

As allopathy and Ayurveda stem from different model of human body, it is also unfair to demand that a fish has to pass the test of climbing a tree.

So, what could be the way forward if we want Ayurveda to claim a place in the healthcare market?

At this point, AYUSH, the main regulatory authority has opted to solve the problem by going diametrically in opposite direction by accepting that traditional herbs and herbal formulation being in use since ages, they are exempted from seeking statutory approval used for allopathy drugs.

Such a policy may show short term gain, but what it can (and is, if one switches on ones TV set in the afternoon) lead to is rampant and lawless market where false claims will be made by the crooked in the name of AYUSH to make a quick buck.The solution that I see is to separate the safe-to-consume and efficacy and design a policy that forces manufacturers to have transparency about their claims.

AYUSH needs to ensure that any alternative medicine from any stream or tradition is made to pass through tests that prove that its is safe-to-consume.

There can be absolutely no compromise with ensuring safety for consumption, even if it is a traditional practice going back to a thousand years.

One the other hand, the need to establish efficacy should not be mandatory for AYUSH medicines, but with a condition, and that is a clear admission made on the package that the efficacy is based on the traditional knowledge and not established through clinical trials.

If a manufacturer wishes to opt for clinical trials and pass through the process it is clear that that medicine needs no classification as it is as much an allopathic medicine as any.

If AYUSH opts for such a clarity and India communicates this to the world regulators, there is a great possibility that we will find buyers across the world who will trust the backing of Ayurvedic traditional knowledge without having clinical proof as long as there is a clear proof that it is not a harmful-to-consume medication.

As long as a substance is safe to consume, getting into efficacy issue is actually a regulatory overreach as it is not correct for any regulator to go into the faith-based choice of a consumer. In fact, if we start putting allopathic drugs through the same logic, a lot of them may fail when the timeframe of clinical trials is prolonged as we now know that there are many a long-term side effects that escape the scrutiny of clinical trials.

Curing ones body is a fundamental right of a human being and the state must not control ones freedom of choice regarding the option one takes beyond a point.

Views expressed above are the author's own.

END OF ARTICLE

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Alternative medicines regulations: Should AYUSH focus on safe-to-consume or efficacy? - The Times of India Blog

BRIDGEWATER, N.J., Oct. 28, 2021 /PRNewswire/ --Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today reported financial results for the third quarter ended September 30, 2021 and provided a business update.

"In the third quarter of 2021, Insmed made important progress against our strategic priorities, including steady performance of our commercial operations, advancement of our clinical development programs in line with expectations, and meaningful acceleration of our translational medicine efforts with a sharp focus on disruptive technologies that we believe will have a significant impact on patients' lives," commentedWill Lewis, Chair and Chief Executive Officer of Insmed. "Notably, we are excited about our launch progress for ARIKAYCE in Japan, where we are already seeing positive early trends. As we navigate this critical execution period for Insmed, we are well-capitalized and highly driven to launch the next phase of growth for our company and to serve many more patients around the world."

Recent Corporate Developments & Program Highlights

ARIKAYCE

Brensocatib

TPIP

Third Quarter 2021 Financial Results

Balance Sheet and Planned Investments

As of September 30, 2021,Insmedhad cash and cash equivalents of$846.6 million. The Company's total operating expenses for the third quarter of 2021 were $150.4 million. Adjusted R&D expenses for the third quarter of 2021 were $64.3 million and adjusted SG&A expenses for the third quarter of 2021 were $51.8 million. Adjusted R&D expenses and adjusted SG&A expenses are non-GAAP measures, which we describe further below.

The Company plans to continue to invest in the following key activities:

(i)

U.S. commercialization of ARIKAYCE;

(ii)

launch activities for ARIKAYCE in initial European countries and in Japan; and

(iii)

clinical trial activities, including (a) advancement of the frontline clinical trial program for ARIKAYCE (ARISE and ENCORE), (b) advancement of the Phase 3 ASPEN study of brensocatib in patients with bronchiectasis, (c) advancement of clinical development of TPIP, and (d) advancement of our translational medicine efforts.

Conference Call

Insmedwill host a conference call beginning today at8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (844) 200-6205 (U.S. toll free), (646) 904-5544 (U.S. local), or +44-208-0682-558 (international) and referencing access code 594997. The call will also be webcast live on the Company's website atwww.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through November 26, 2021 by dialing (866) 813-9403 (U.S. toll free), (929) 458-6194 (U.S. local), or +44-204-525-0658 (international) and referencing access code 963633. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at http://www.insmed.com.

Non-GAAP Financial Measures

In addition tothe U.S.generally accepted accounting principles (GAAP) results, this earnings release includes non-GAAP financial measures: adjusted R&D expenses, whichInsmeddefines as R&D expenses less stock-based compensation expense and depreciation; and adjusted SG&A expenses, which Insmed defines as SG&A expenses less stock-based compensation and depreciation. A reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measure is presented in the table attached to this press release.

Management believes that these non-GAAP financial measures are useful to both management and investors in analyzing our ongoing business and operating performance. Management believes that providing this non-GAAP information to investors, in addition to the GAAP results, allows investors to view our financial results in the way that management views financial results.Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies.

About ARIKAYCE

ARIKAYCE is approved inthe United Statesas ARIKAYCE(amikacin liposome inhalation suspension), in Europe as ARIKAYCELiposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product).Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the LamiraNebulizer System manufactured by PARI Pharma GmbH (PARI).

About PARI Pharma and the LamiraNebulizer System

ARIKAYCE is delivered by a novel inhalation device, the LamiraNebulizer System, developed by PARI. Lamirais a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.

About Brensocatib

Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction.

About TPIP

Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated for the treatment of patients with PAH and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.

IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S.

WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS

ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.

Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.

Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). Ifhemoptysis occurs, manage patients as medically appropriate.

Bronchospasmhas been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%)compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate.

Exacerbations of underlying pulmonary diseasehas been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.

Anaphylaxis and Hypersensitivity Reactions:Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.

Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimenalone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm).Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.

Nephrotoxicitywas observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.

Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.

Embryo-Fetal Toxicity:Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.

Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.

Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence 5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).

Drug Interactions:Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.

Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified.Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.

U.S. INDICATION

LIMITED POPULATION: ARIKAYCEis indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium aviumcomplex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.

This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch, or call 1800FDA1088. You can also call the Company at 1-844-4-INSMED.

Please seeFull Prescribing Information.

About Insmed

Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed's first commercial product is a first-in-disease therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company is also progressing a robust pipeline of investigational therapies targeting areas of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a growing footprint across Europe and in Japan. For more information, visit http://www.insmed.com.

Forward-looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside the U.S., Europe or Japan, or for the Company's product candidates in the U.S.,Europe,Japanor other markets; failure to successfully commercialize ARIKAYCE, the Company's only approved product, in the U.S., Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; impact of the COVID-19 pandemic and efforts to reduce its spread on the Company's business, employees, including key personnel, patients, partners and suppliers; risk that brensocatib does not prove effective or safe for patients in ongoing and future clinical studies, including the ASPEN study; risk that TPIP does not prove to be effective or safe for patients in ongoing and future clinical studies; uncertainties in the degree of market acceptance of ARIKAYCE by physicians, patients, third-party payors and others in the healthcare community; the Company's inability to obtain full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that the Company will not successfully or in a timely manner complete the study to validate a PRO tool and the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE; inability of the Company, PARI or the Company's other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the LamiraNebulizer System; the Company's inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE; development of unexpected safety or efficacy concerns related to ARIKAYCE or the Company's product candidates; inaccuracies in the Company's estimates of the size of the potential markets for ARIKAYCE or its product candidates or in data the Company has used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company's inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of the Company's product candidates that are approved in the future; failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP and the Company's other product candidates due to the Company's limited experience in conducting preclinical development activities and clinical trials necessary for regulatory approval and its potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that our clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE or the Company's product candidates for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company; the Company's inability to attract and retain key personnel or to effectively manage the Company's growth; the Company's inability to successfully integrate its recent acquisitions and appropriately manage the amount of management's time and attention devoted to integration activities; risks that the Company's acquired technologies, products and product candidates are not commercially successful; the Company's inability to adapt to its highly competitive and changing environment; the Company's inability to adequately protect its intellectual property rights or prevent disclosure of its trade secrets and other proprietary information and costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on the Company by agreements related to ARIKAYCE or the Company's product candidates, including its license agreements with PARI and AstraZeneca AB, and failure of the Company to comply with its obligations under such agreements; the cost and potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability claims; the Company's limited experience operating internationally; changes in laws and regulations applicable to the Company's business, including any pricing reform, and failure to comply with such laws and regulations; inability to repay the Company's existing indebtedness and uncertainties with respect to the Company's ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year endedDecember 31, 2020 and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Financial Statements and Reconciliation Follow

INSMED INCORPORATED

Consolidated Statements of Net Loss

(in thousands, except per share data)

(unaudited)

Three Months Ended September 30,

Nine Months Ended September 30,

2021

2020

2021

2020

Product revenues, net

$ 46,757

$ 43,643

$ 132,337

$ 122,998

Operating expenses:

Cost of product revenues (excluding amortization

of intangible assets)

10,183

10,622

30,864

29,010

Research and development

70,347

41,411

196,392

113,343

Selling, general and administrative

60,280

46,585

169,007

147,594

Amortization of intangible assets

1,264

1,248

3,790

3,745

Change in fair value of deferred and contingent

consideration liabilities

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Insmed Reports Third Quarter 2021 Financial Results and Provides Business Update - KPVI News 6

PLYMOUTH MEETING, Pa., Oct. 27, 2021 /PRNewswire/ -- INOVIO (NASDAQ: INO) announced today that third quarter 2021 financial results will be released after the market close on November 9, 2021. Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company's global Phase 3 efficacy trial (INNOVATE) involving its COVID-19 vaccine candidate, INO-4800.

A live and archived version of the audio presentation will be available online at http://ir.inovio.com/events-and-presentations/default.aspx. This is a listen-only event but will include a live Q&A with analysts.

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead therapeutic candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1, the first of two, Phase 3 trials for precancerous cervical dysplasia, demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV-16/18. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2/3 clinical trial; the Phase 3 segment of which has received regulatory approvals to begin in Colombia, Mexico, Brazil and Philippines. INOVIO's partners, Advaccine Biopharmaceuticals and International Vaccine Institute, are also evaluating INO-4800 in ongoing clinical trials in China and South Korea, respectively.

Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Defense Advanced Research Projects Agency/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense/Department of Defense, HIV Vaccines Trial Network, International Vaccine Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium, National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit http://www.inovio.com.

Story continues

CONTACTS:Media: Jeff Richardson, 267-440-4211, jrichardson@inovio.comInvestors: Ben Matone, 484-362-0076, ben.matone@inovio.com

This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2020 , our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

Cision

View original content:https://www.prnewswire.com/news-releases/inovio-to-report-third-quarter-2021-financial-results-on-november-9-2021-301409612.html

SOURCE INOVIO Pharmaceuticals, Inc.

Link:

INOVIO to Report Third Quarter 2021 Financial Results on November 9, 2021 - Yahoo Finance

PALM BEACH, Fla., Oct. 26, 2021 /PRNewswire/ --FinancialNewsMedia.com News Commentary- The global psychedelic drugs market remains at an early stage in its life cycle, with most companies currently developing their go-to-market strategy. The market players of psychedelics are involved in the clinical trials of several psychedelic drugs to address mental health, which continues to present significant unmet need.For the behavioral health industry, psychedelics present an opportunity to potentially bolster providers' treatment toolbox and help patients for whom current psychiatric medications have failed. While it's unclear exactly what the future of psychedelics in the U.S. behavioral health industry will look like, Canadians are looking at a clearer picture. When it comes to psychedelic wellness, Canada is leading the way, accordingto Behavioral Health Business. They said: Regulations were recently relaxed there to make it easier for alternative medicine companies to develop psychedelic behavioral health treatments.Those newfound flexibilities are similar to right-to-try laws in the US, which allow terminally ill patients to use experimental therapies that have passed Phase I in the U.S. Food and Drug Administration's approval process.The difference, however, is that only one state in the US along with several municipalities has authorized exemptions for psilocybin; meanwhile, all 13 Canadian provinces and territories currently have exemptions for the psychedelic substance often used as a source for alternative behavioral health treatments." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), Eli Lilly and Company (NYSE: LLY), Johnson & Johnson (NYSE: JNJ).

Under the care of a clinician, patients using psilocybin for behavioral health treatment typically receive the psychedelic drug to treat conditions like stress, anxiety and depression, especially for patients who have not had success using other treatments or are facing terminal illnesses. As with the US, possession of psilocybin mushrooms in Canada is illegal. However, last August, Health Canada the country's regulatory health body approved the use of psilocybin to treat four terminally ill patients for anxiety, stress and depression.Several months later, in December,Health Canada also approved exemptions to a group of doctors and therapiststo use psilocybin for research purposes, allowing them to study its effects on patients in hopes of developing therapies for future use. As a result, British Columbia which is also home to a number of Canadian cannabis companies has become a hotbed for psychedelic wellness startups.

Cybin Inc. (NYSE AMERICAN: CYBN) (NEO: CYBN) BREAKING NEWS: Cybin Announces FDA Investigational New Drug Authorization of Cybin's Sponsored Feasibility Study using Kernel Flow Technology - Cybin Inc. ("Cybin" or the "Company"), a biotechnology company focused on progressing psychedelic therapeutics, today announced that the U.S. Food and Drug Administration ("FDA") has authorized an Investigational New Drug ("IND") application to proceed with the Company's sponsored feasibility study using Kernel's Flow technology to measure ketamine's psychedelic effect on cerebral cortex hemodynamics.

"The word psychedelic means 'mind-manifesting,' but what has been missing is useful 'mind-imaging'the ability to dynamically trace the neural correlates of human conscious experience. Conventional neuroimaging just isn't dynamic enough to study the psychedelic experience in the brain as it happens. This study of ketamine's psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding," said Dr. Alex Belser, Cybin's Chief Clinical Officer.

Leveraging Kernel's quantitative neuroimaging technology ("Kernel Flow") may lead to new frontiers in psychedelic therapeutics by enabling the acquisition of longitudinal brain activity before, during and after a psychedelic experience, providing quantification of what was previously subjective patient reporting.

"Quantitatively measuring the brain within the context of a psychedelic experience is a promising frontier," said Bryan Johnson, founder and Chief Executive Officer of Kernel. "With Kernel Flow, Cybin's researchers can start putting numbers and quantification to subjective states of mind, including altered ones."

Kernel Flow uses pulsed light instead of continuous wave light to increase measured brain information. In contrast with electroencephalography ("EEG") electrodes that usually require gel on the head or functional magnetic resonance imaging ("fMRI") studies that require a participant to lie in a scanner, Kernel Flow is easily wearable. The entire system is the size and look of a bicycle helmet and could, in the future, be more broadly used for neuroscientific or physiological studies of brain activity during psychedelic use.

As part of Cybin's sponsorship of the feasibility study, the Company will retain an exclusive interest in any innovations that are discovered or developed through its independent analysis of the study findings. Kernel will hold the same rights relating to its Kernel technology. CONTINUEDRead the full Press Release for Cybin at: https://www.cybin.com/news

In other active company biotech news in the markets this week:

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently welcomed the topline data shared from an open-label study of psilocybin therapy for depression in cancer patients. Within one week of a single administration of COMP360 psilocybin therapy, 50% of participants achieved remission in depression symptoms, which was sustained for the eight week follow-up period.

This investigator-initiated feasibility study was conducted by Maryland Oncology Hematology at the Aquilino Cancer Center in Rockville, Maryland, USA. It was an open-label study involving 30 patients with cancer diagnosis and major depressive disorder (MDD), all of whom completed the study. Half of the participants had previously been treated for their current episode of depression with antidepressants and all were receiving active treatment for cancer; 19 participants had no previous experience with psychedelic substances. Patients were given a 25mg dose of COMP360 psilocybin in conjunction with psychological support from specially trained therapists, following the COMP360 psilocybin therapy protocol.

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a leading biotech company developing psychedelic-inspired therapies, recently announced that Dr.Matthias Liechtipresented data from several ongoing studies at the INSIGHT Conference inBerlin, Germany. These investigator-initiated studies are being conducted as part of MindMed's ongoing collaboration with the UHB Liechti Lab.

"While both LSD and psilocybin have a long history in psychiatric research, psilocybin is being studied in a majority of ongoing clinical trials of psychedelics," said Dr. Liechti. "It is important for us to understand the acute effect characteristics of different psychedelics, and to understand how these substances interact with other treatments like antidepressants. We look forward to fully analyzing the exciting data produced by these studies and publishing our findings later this year."

Eli Lilly and Company (NYSE: LLY) recently announced the board of directors of Eli Lilly and Company (NYSE: LLY) has declared a dividend for the fourth quarter of 2021 of $0.85 per share on outstanding common stock.

The dividend is payable on December 10, 2021 to shareholders of record at the close of business on November 15, 2021.Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Johnson & Johnson (NYSE: JNJ) The Janssen Pharmaceutical Companies ofJohnson & Johnson(Janssen) previously announced the submission of a New Drug Application (NDA) to theU.S. Food and Drug Administration(FDA) for esketamine nasal spray. Janssen is seeking FDA approval of esketamine for treatment-resistant depression in adults.

Esketamine is an investigational, rapidly acting antidepressant that works differently than currently available therapies for major depressive disorder. Through glutamate receptor modulation, esketamine is thought to help restore connections between brain cells in people with treatment-resistant depression.

"Of the nearly 300 million people who suffer from major depressive disorder worldwide, about one-third do not respond to currently available treatments.3,4This represents a major unmet public health need," saidMathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are committed to working with the FDA to bring this new treatment option toU.S.patients with treatment-resistant depression and to the medical community."

DISCLAIMER: FN Media Group LLC (FNM), which owns and operates Financialnewsmedia.com and MarketNewsUpdates.com, is a third- party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. FNM is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNM was compensated twenty six hundred dollars for news coverage of current press release issued by Cybin Inc.by a non-affiliated third party. FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.

Contact Information:Media Contact email: [emailprotected] +1(561)325-8757

SOURCE FinancialNewsMedia.com

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North America Continues Leading The Way In Psychedelic Wellness - PRNewswire

Introduction

SARS-Cov-2 is a novel coronavirus causing the severe acute respiratory syndrome spreading around the world since the end of 2019.1,2 It belongs to a family of single-stranded RNA viruses (+ssRNA), as the severe acute respiratory syndrome virus (SARS-CoV) and the Middle East respiratory syndrome virus (MERS-CoV). SARS-CoV-2 infection can cause mild to severe pneumonia and its mortality rate is higher in patients with comorbidities and older patients.3,4 Although different vaccines for the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection have been developed and are now available,5 there are no effective antiviral drugs to treat the disease, except for Remdesivir authorized by the United States Food and Drug Administration (US FDA) to counteract the emergency.6 mRNA-based vaccines were developed by Moderna and Pfizer/BioNTech,7,8 but there is still uncertainty about their efficacy (~95%), safety, and immunogenicity concerning SARS-CoV-2 spike glycoprotein (S protein). Similarly, viral vector vaccines were produced by Johnson and Johnson and by the University of Oxford/AstraZeneca, although the safety of AstraZenecas vaccine is currently under revision.9,10 Unfortunately, new strains of the virus have developed so far with new mutations and this could inhibit the effectiveness of vaccines, and delays the end of the pandemic.11 Given the high infectivity of new mutations in the virus and the slowness of vaccine programming, herd immunity will be difficult to achieve in a short time. It is very likely that new coronavirus diseases may still emerge in the future. Thus, it can be necessary to develop alternative therapies based on the use of natural compounds, as epigallocatechin-3-gallate (EGCG), with antiviral features, to circumvent SARS-CoV-2 infection. EGCG, is the principal constituent and most important polyphenolic catechin found in green tea.1218 As largely reported, EGCG possesses many biological properties (ie antioxidant, antitumor, anti-inflammatory) due to a galloyl side chain contained in its chemical structure.19 It has been shown that polyphenols and EGCG, through sticking with some molecules present in viruses, are able to regulate their functions. Specifically, EGCG by binding to the receptors present on the membrane of the host cells or directly to the viral surface inhibits the interaction between the host cells and the virus. As a result, EGCG represses the replication and the transcription of the virus, thus inactivating its activity.20,21 As recently detailed described by Wang et al,22 EGCG has inhibitory activities towards different viruses. Specifically, EGCG is able to suppress the replication, the transcription and the infection of DNA virus as Hepatitis B Virus (HBV),2327 Herpes Simplex Virus (HSV)2831 and Epstein-Barr Virus (EBV) through different molecular mechanisms.3235 Moreover, EGCG has similar effects on RNA virus as Human Immunodeficiency Virus (HIV),3742 Hepatitis C virus (HCV),4345 and Influenza A virus (IAV).4648 Additionally, in vitro studies demonstrated that EGCG is capable to inhibit the replication of some Enterovirus (CVB3, EV71) by regulating the oxidative stress of host cells.49,50 Similar effects were also detected in Arboviruses, particularly in Chikungunya virus (CHIKV).5155 Finally, several pre-clinical studies confirmed the antiviral activity of EGCG also against Coronaviruses, especially against SARS-Cov-2.5673 Basically, EGCG can inhibit the cell entry of these viruses or their replication and transcription, through different molecular mechanisms which are not completely known. In this review, we summarize these experimental pieces of evidence and highlighted the potential use of EGCG as an alternative therapeutic choice for alleviating or treat SARS-Cov-2 infection.

COVID-19 is caused by SARS-CoV-2 infection.56 The initial clinical manifestations of COVID-19 include respiratory symptoms, such as fever, fatigue and dry cough, are accompanied by atypical clinical manifestations such as sore throat, headache and diarrhea.57 Around one week later, patients exhibited difficulty breathing and hypoxia, during which the secretion of intracellular pro-inflammatory factors Interleukin-6 (IL-6), Interleukin-17 (IL-17) and tumor necrosis factor (TNF-)) increased significantly, and the total number of circulating lymphocytes decreased. Then, the symptoms rapidly deteriorated into acute respiratory distress syndrome (ARDS), sepsis, blood coagulation dysfunction and irreversible metabolic acidosis. Eventually, some severe cases would lead to death. Structurally, SARS-CoV-2 contains four proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N) proteins. During host cell entry, SARS-CoV-2 relies on its S proteins for binding to the host cell-surface receptor. The S protein binds to the host receptor through the receptor-binding domain (RBD) in the S1 subunit, followed by the fusion of the S2 subunit to the cell membrane. SARS-CoV-2 recognizes the cell membrane receptor angiotensin-converting enzyme 2 (ACE2) receptor to bind with the viral S protein, thus forming RBDACE2 complex, by which the virus is embedded into the host cell where it starts replication. Thus, if a substance can bind the S protein, or possesses a strong affinity to ACE2 receptor, which blocks the formation of RBDACE2 complex, it could suppress the viral entry into host cells. Regarding the antiviral effects of EGCG on SARS-CoV-2, different pre-clinical studies have been performed (Table 1). Basically, the inhibition effects of EGCG on SARS-CoV-2 replication occur through its actions on the ACE2 receptor, the main protease (Mpro, a 3C-like protease) and RNA-dependent RNA polymerase (RdRp) (Figure 1).

Table 1 A Summary of Pre-Clinical Studies on the Antiviral Activity of EGCG Against SARS-Cov-2

Figure 1 The inhibitory effects of EGCG on SARS-CoV-2 life cycle. The figure represents the inhibitory effects of EGCG on SARS-CoV-2 cycle. Basically, the inhibition effects of EGCG on SARS-CoV-2 replication occurs through its actions on the ACE2 receptor, the main protease (Mpro, a 3C-like protease) and RNA-dependent RNA polymerase (RdRp).

Abbreviations: EGCG, epigallocatechin-3-gallate; pp1a, nuclear protein phosphatase 1 ; pp1ab, 2-O-methyltransferase; Mpro, main protease; ACE2, angiotensin-converting enzyme 2; S-protein, spike protein; RdRp, RNA-dependent RNA polymerase.

Mhatre et al58 reviewed the antiviral activities of EGCG theaflavin-3,3-digallate (TF3) against positive-sense single-stranded RNA viruses, including SARS-CoV-2. The authors suggested that both the tea polyphenols are capable to interact with the receptors present in the structure of SARS-CoV-2 virus, thus inhibiting its replication. Particularly, the theaflavins (TFs), can be employed as prophylactic agents due to their capacity to bind Spike receptor-binding domain (RBD), the principal binding domain of the S protein located on the S1 subunit of SARS-CoV-2 virus. EGCG can be used as a potential prophylactic due to its ability to dock to various active sites of SARS-CoV-2 virus. The authors highlighted the needing of additional studies on the specificity, safety, and efficacy of these polyphenols, to confirm their use not only as a dietary supplement, but also as therapeutic agents for COVID-19 infections. Menegazzi et al,59 speculated that EGCG and others catechins (ie, GTE) supplementation could be effective in controlling the inflammation damages occurring in SARS-CoV-2 infection, through complex molecular mechanisms involving different interacting transcriptor factors (ie signal transducer and activator of transcription, STAT; nuclear factor kappa-light-chain-enhancer of activated B cells, NF-B; NF-E2related factor 2; Nuclear Factor Erythroid-Derived 2-Related Factor 2, Nrf2). Similarly, Mendonca et al,60 suggested that the combination of EGCG, thymoquinone (TQ), and vitamin D3 can activate Nrf2-dependent genes and preserve the cells against SARS-CoV-2 infection. Singh et al,61 studied the binding of polyphenols (ie, EGCG, TF1, TF2a, TF2b, hesperidin, quercetagetin, and myricetin) with SARS-CoV-2 RdRp and thus tested their potential to treat COVID-19. The authors demonstrated that EGCG, TF1, TF2a, TF2b, TF3, can bind (in highly stable manner) to the active site of RdRp. These four natural polyphenols can act as potential inhibitors for the SARS-CoV-2 RdRp, although additional studies will be necessary to validate their efficacy against SARS-CoV-2 infection. An in-silico analysis conducted by Sagaama et al,62 revealed that the succinic acid (SA), L-pyroglutamic acid (L-PGA), N-phenyl-thioacetamide (N-NPTA), 2-amino-5-chloropyridine hydrogen succinate (ACPS), epigallocatechine Gallate (EGCG) or, 2-oxoglutarate dehydrogenase E1 component putative (KDH) and, selenomethionine (SeM) compounds could represented potential antiviral candidates for treatment of COVID-19 based on B3LYP/6-311++G** calculations and molecular docking. Data emerged from this study suggest that the compounds ACPS and KDH are powerful species in the treatment of SARS-CoV-2 infections. A different study conducted by Jang et al,63 demonstrated that EGCG and theaflavins, inhibited activity against the SARS-CoV-2 3CL-protease, in HEK293T cells, in a dose-dependent manner and without signs of cytotoxicity for both compounds at any dose used. Sharma et al,64 performed an in-silico drug repurposing followed by molecular dynamics (MD) simulation and MM-GBSA calculation for targeting SARS-CoV-2 main protease (Mpro). Mpro was screened for already known FDA approved drugs and some natural compounds, including EGCG. Specifically, the authors proposed that EGCG, withaferin A, dolutegravir and artesunate could be considered potential drugs for COVID-19. A molecular docking studies was also conducted by Mhatre et al,65 to study the exact interaction of EGCG and TF3 with the putative binding sites of SARS-CoV-2. The in-silico results emerged from this study should promote the evaluation of the broad-spectrum antiviral activity of the tea polyphenols in the treatment of COVID-19. Similarly, Zhu et al66 performed in vitro studies by using of the Mpro of SARS-Cov-2 for docking simulation to screen flavan-3-ols and proanthocyanidins (Pas), to identify potential candidates for counteracting SARS-Cov-2 infection. Data emerged from docking simulation and in vitro assay, indicated that ()-catechin-3-O-gallate (CAG), ()-epicatechin-3-O-gallate (ECG), ()-gallocatechin-3-O-gallate GCG), EGCG, procyanidin A2 (PA2) and B2 (PB2) are able to inhibit the Mpro activity of SARS-Cov-2, thus can be used to interfere with SARS-Cov-2 infection. Wang et al,67 conducted in-depth and comprehensive bioinformatics analysis for the screening of therapeutic drugs and their related pathways in COVID-19 disease. Results indicated that trans-resveratrol, EGCG and BX795 possess multiple anti-viral effects. It is of note that coronaviruses encode for polyproteins that are cleaved by 3CL protease for maturation. Thus, 3CL protease could be considered the main target of antivirals against coronaviruses. Based on this concept, Chiou et al,68 conducted an in vitro study on the inhibitory effects of 1,2,3,4,6-pentagalloylglucose (PGG) and EGCG against the SARS-CoV-2- 3-chymotrypsin-like protease (3CLpro) protease. Data revealed that PGG and EGCG inhibited of viral protease activity of SARS-CoV-2 3CLpro, thus suggesting their potential application in the treatment of SARS-CoV-2 infection. Later on, in a fascinating study Du et al,69 screened and identified, by using multiple strategies (ie molecular docking, surface plasmon resonance, fluorescence resonance energy transfer (FRET)-based inhibition assay) different active ingredients of Traditional Chinese Medicine (TCM) with inhibitory effects against SARS-CoV-2 3CLpro, including EGCG. Results demonstrate that EGCG showed a higher affinity with SARS-CoV-2 3CLpro thus suggesting its potential in the treatment of COVID-19 disease. A fascinating in vitro study performed by Jang et al,70 demonstrated that EGCG can inhibit coronavirus replication. Specifically, the authors used low pathogenic human coronavirus HCoV-OC43 (beta coronavirus) and HCoV-229E (alpha coronavirus), as a coronavirus model system to dissect the effect of EGCG on coronavirus processing. Results demonstrated that EGCG treatment decreases viral RNA and viral protein production in the media suggesting that EGCG inhibits coronavirus replication. By using the molecular docking approach, Chourasia et al71 demonstrated that the catechins (mainly EGCG and ECG) inhibited papain-like protease protein (PLPro). Specifically, catechin bind to the S1 ubiquitin-binding site of PLPro, which restrain its protease function and abolish SARS-CoV-2 inhibitory function on ubiquitin proteasome system and interferon stimulated gene system. Considering EGGCs antiviral and anti-inflammatory properties, the authors concluded that these natural compounds could be considered as a putative therapeutic agent for SARS-CoV-2 infection. Finally, a recent research conducted by Henss et al,72 examined the antiviral activity of EGCG against SARS-CoV-2. EGCG arrested the entry of SARS-CoV-2, MERS and SARS-CoV pseudo typed lentiviral vectors and restrained virus infections in vitro. Moreover, an inhibition of the SARS-CoV-2 spikereceptor interaction was also detected. Altogether these finding highlighted the potential use of EGCG as an alternative therapeutic choice for the treatment of SARS-CoV-2 infection.

Here, we summarized recent findings on the potential role of EGCG in the treatment of SARS-CoV-2 infection. Accumulated pieces of evidence reported that EGCG has antiviral properties against different viruses, including SARS-Cov-2.22 Specifically, it has been proved that EGCG inhibits the enzymatic activity of the coronavirus 3CL protease, thus interfering with its replication. Moreover, EGCG can regulate specific target as the viral S protein and RdRp. EGCG is also capable of inhibiting the replication of coronaviruses in cell cultures. Results from molecular docking analyses demonstrated that EGCG prevents SARS-CoV-2 entry into the target cell through inhibition of RBD in viral membrane identifying with ACE2. Finally, EGCG can interfere with the viral start replication by suppressing Mpro activity, although all these effects should be confirmed in vivo. A set of experiments evaluated the in vivo distribution of EGCG in human bodies7479 and data showed that the values of EGCG concentration in the colon and intestine were higher than most of the concentrations necessary to promote 3CL protease required to effectively 3CL protease inhibition. More pre-clinical studies, clinical trials and epidemiological analysis will be extremely needed to validate EGCG anti-COVID-19 applications. EGCG and its stable lipophilic derivatives could also be potential prophylactic as well as therapeutic agents looking at their properties to dock at various active sites of SARS-CoV-2. Results from these studies will shed light on the role of the EGCG and the underlying molecular mechanisms for the treatment of SARS-CoV-2 infection. However, based on the current results published in the literature, it is not possible to say at all that EGCG can be considered as an election therapeutic drug for Covid-19. Due to the absence of specificity, EGCG could bind to other proteins present in the human body, thus provoking side-effects. EGGC may not be used in the treatment of COVID-19, but as a nutraceutical or dietary supplement, especially in the earlier stages of clinical manifestations of COVID-19. After extensive studies on EGGC and other similar polyphenols regarding their specificity, activity, bioavailability and safety, there can be considerations on their use in the treatment of viral infections including COVID-19.

We are grateful to Dr. Alessandra Trocino and Mrs. Cristina Romano from the National Cancer Institute of Naples for providing excellent bibliographic service and assistance. Sabrina Bimonte and Cira Antonietta Forte are co-first authors of this study. Marco Cascella and Arturo Cuomo are co-last authors of this study.

All authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article will be submitted, gave final approval for the version to be published, and agree to be accountable for all aspects of the work.

The authors report no conflicts of interest in this work.

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