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Daily Archives: May 3, 2022
Cybin’s CYB0004 Shows Positive Preclinical Results Over …
Posted: May 3, 2022 at 10:23 pm
CYB004 is one of Cybins CYBN proprietary second-generation psychedelics, developed to treat depression, anxiety, and substance abuse disorders. According to the company, the substance has recently shown positive preclinical data over DMT, the molecule from which it is derived.
Cybin has observed that the preclinical study showed promising results for CYB004 regarding bioavailability, duration of the effect, and the onset of the psychoactive effect.
When compared with oral DMT, Cybins proprietary substance showed an increase in bioavailability of almost 2000% (since orally administered DMT shows little to no bioavailability), and of 41% when compared to inhaled DMT. Regarding the duration of the effect, CYB004 lasted almost three times longer as intravenously administered DMT.
DMT has shown to be a promising and effective psychedelic for the treatment of mental health issues. However, known side effects like disorientation and anxiety and its mode of administration have historically hindered its use and availability. CYB004 via inhalation may solve these challenges and finally support a clinical path forward for this important therapeutic, commented Doug Drysdale, CEO of the company. Inhaled CYB004 is being developed to potentially overcome the limitations of IV DMT and become an important treatment option for anxiety disorders for patients and physicians.
The company plans to submit a regulatory filing for a pilot study in the second quarter of 2022, with the aim to initiate it in the following quarter.
CYB004 is administered through inhalation, and Cybin has applied for a patent for that delivery method.
This year, at the upcomingBenzinga Psychedelics Capital Conference, to be held onApril 19 at the Fontainebleau MiamiBeach Hotel in Florida, Doug Drysdale will share his vision and valuable insights about the burgeoning sector.
Photo: Courtesy ofLouis ReedonUnsplash
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Psychedelics played role in Wallace Falls hiker’s death …
Posted: at 10:23 pm
Witnesses say the 25-year-old woman fell down along the trail and refused help.
SNOHOMISH COUNTY, Wash A 25-year-old woman has been found dead near Wallace Falls in Snohomish County. Police suspect psychedelic mushrooms played a part.
Leigh Kuppler was out for a hike at the falls with her partner last Friday when they ran into a pair of young women.
At one point, she was standing there, and she fell straight back onto the ground, hitting her head on the rocks," said Kuppler.
According to Kuppler, the women appeared intoxicated but not drunk. One of the women had torn clothing and dirt on her face.
She hugged us and said, 'I hope you enjoy this trail, said Kuppler. "Then she hugged her friend. After that, she took a couple steps back and was standing looking at us, and she fell straight back hitting her head again."
Kuppler tried to help the hikers, but they refused.
Her friend was just saying that everything was fine and to leave them alone," said Kuppler.
Concerned for their safety, Kuppler called 911.
The last words I exchanged with her were, good luck, I hope everything is OK," said Kuppler.
The next morning, a search and rescue crew found 25-year-old Alisonstar Molaf of New Jersey dead near the Wallace River.
The Snohomish County Sheriff's Office said both women were "under the influence of mushrooms."
It really sits heavy with me knowing I was the last one to see her alive, and it just happened so quickly," said Kuppler.
The trail to Wallace Falls can be dangerous because there are cliffs along the way.
It isn't hard for people to get in trouble when they're sober. Experts said the odds of something bad happening increase exponentially under the influence of psychedelics.
In a dangerous environment, I think accidents are prone to happen," said University of Washington researcher Dr. Nathan Sackett.
Sackett believes psilocybin, the active ingredient in hallucinogenic mushrooms, is quite safe on its own.
Psychedelic mushrooms are growing in popularity with their decriminalization in Oregon, the trend of "microdosing" small amounts to increase creativity, and their promising use as a therapeutic for everything from depression to addiction.
However, mushrooms can also make people hallucinate, act impulsively and not think of any potential consequences for their actions.
This is a big concern of mine," explained Sackett. As psychedelics become culturally more normative, it's really important that people know they should do them in a controlled environment. Hopefully, one day, people won't have to hide in the woods to experience them."
The official cause of Molaf's death has not been determined by the Snohomish County Medical Examiner. Sheriff's department investigators announced her death does appear to be accidental.
For people intent on experimenting with mushrooms, or any psychedelic, Sackett advised people to be in a safe place with people they trust and to have a sober person on hand if things take a dangerous turn.
It really is frustrating, and it's hard to deal with because I wish I could've done more," said Kuppler. "I think we did the right thing, though, by calling someone who could help. You just don't know what's gonna happen."
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The Mainstream Healthcare VCs Dipping Their Toes Into Psychedelics – Business Insider
Posted: at 10:23 pm
In recent years, dozens of newcompanies have begun to undertake the long and expensive process of developing psychedelics-based drugs for regulatory approval.
In turn, a handful of VC firms focused specifically on funding psychedelics businesses have stepped up to the plate, helping to spur studies around compounds like MDMA, psilocybin, and LSD for a plethora of illnesses.
But as drugs inch closer to approval by regulatory bodies like the Food and Drug Administration, they also become much more expensive to develop, since later-stage clinical trials often require larger numbers of participants, more trial sites, and longer trial lengths.
Enter mainstream healthcare VCs, who are dipping their toes into the still-nascent industry and have the deep pockets to support expensive late-stage clinical trials, which are crucial in order to get any new drug to market.
While a handful of high-net-worth individuals and tech investors have made investments in studying the use of psychedelics as medicine, the entry and sustained presence of mainstream healthcare VCs marks a new level of acceptance for the space, one that brands psychedelics as promising treatment for mental-health disorders in established biotech circles.
Insider scoured press releases and talked with healthcare analysts and psychedelics VCs in order to understand which mainstream healthcare VCs are leading the charge on turning psychedelics into regulated treatments.
One of the most high-profile healthcare VCs that has invested in psychedelics companies is Boston-based RA Capital. The firm, which has previously invested in companies including Novavax and Moderna, has funded at least three psychedelics-focused companies since 2020: GH Research, Cybin, and Delix Therapeutics.
All three companies are working to develop psychedelics-based compounds to treat mood disorders such as depression and anxiety.
According to CB Insights, RA Capital was one of the most active healthcare VCs in the second quarter of 2021. RA Capital did not respond to Insider's request for comment.
Other mainstream firms, like Catalio Capital and OrbiMed have made at least two investments into the space.
Catalio Capital was founded in 2020, when it spun out from Camden Partners Holdings to focus on expanding its investments in the biotech space. It has invested in biotech companies including Thrive Earlier Detection, Recursion, and Freenome. The firm backed the psychedelics companies Atai and Compass Pathways when the companies were private, and since their respective IPOs, Catalio has continued to hold positions.
New York-based OrbiMed, which has invested in over 80 life-sciences startupsincluding diagnostics giants Invitae and Guardant Health. The firm has backedAwakn and Cybin in the psychedelics space. Awakn is developing ketamine and MDMA for alcohol-use disorder while Cybin is working to develop compounds like psilocybin and DMT to treat anxiety, neuroinflammation, and other illnesses in early-stage trials.
A smaller healthcare VC firm, Connecticut-based Soleus Capital, has made investments into two psychedelics companies: Compass Pathways and Field Trip.
The vast majority of mainstream healthcare VCs that have made an investment into the psychedelics space have gone in on one name:GH Research.
Almost a dozen mainstream biotech investors, including Deerfield Management Company and Venrock Healthcare Capital Partners, have backed the firm since it was founded in 2018.
Dublin-based GH Research is developing a medicine for treatment-resistant depression that's based on a psychoactive compound called 5-MeO-DMT, found in the Sonoran Desert toad. Its lead compound, GH001, was tested in a phase-one and partial phase-two trial, which wrapped up in November 2021.
The company said it expects to submit clinical trial applications for a phase-two-B trial in the third quarter of 2022.
Connor Williams, an analyst at RTW Investments who covers GH Research and neurological diseases, told Insider that he believes his and other VCs' interest in GH Research is based on the fact that the company's compound didn't have the same "onerous requirements for patients" as the other psychedelics in development. Cowen analyst Ritu Baral added that the pedigree of the company's founders who have substantial biotech experience likely also helped catapult awareness among specialist investors so quickly.
Though the vast majority of mainstream VCs interested in psychedelics have only hedged their bets on GH Research, George Petrocheilos, a managing partner at Catalio, told Insider that he believes more mainstream investors are becoming interested in the space.
"I think it's already happening," Petrocheilos said, adding that he's received a lot of diligence calls and interest calls from mainstream investors who want to better understand the industry.
"They understand that it's a great opportunity," he said.
RTW's Williams agreed that more healthcare VCs may become interested in the space, especially as the science develops.
"If you continue to see strong data with novel compounds that are differentiated, then it could grow," he said. "If you see data get worse, then maybe not. So it's really about following the science."
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LSD Is Back On Campus, But This Time It’s Approved – Green Market Report
Posted: at 10:23 pm
Psychedemia is a mix of psychedelic and academiameaning the integration of psychedelics into academiaand is a term coined by LSD research pioneer Humphry Osmond in 1957.
It has been used since 2012 as the title for a grassroots collaborative psychedelics conference organized to foster novel contributions to this burgeoning field, and to consider data from new research with an open mind.
The three-day psychedemia conference in 2012 was organized by the University of Pennsylvania, the Penn Medicine Neuroscience Center, the Perelman School of Medicine, the Graduate and Professional Student Assembly, the School of Arts and Sciences Student Government, and several other departments was a grand gesture ten years ago to not only raise the awareness of psychedelics but give the whole industry a shot in the arm.
It represented a sort of full-circle path of academia for psychedelics after academia abandoned psychedelics when Harvard University psychology professor Timothy Leary derailed the industry in the 60s after doing experiments with psilocybin and LSD that lacked scientific rigor.
Now academia is reclaiming psychedelics and putting more university brainpower into it than ever before.
The psychedemia conference is still going on, with the next one scheduled in August 2022, as a partnership with the newly founded Center for Psychedelic Drug Research and Education at Ohio State University. It will be presented on the campus.
But academia-inspired conferences and the founding of university-related psychedelics studies centers are just the tip of the iceberg in the huge rush by academia to embrace and better understand psychedelics.
Universities are creating masters degree level psychedelics classes, attracting world-class scientists to help find novel psychedelics therapeutics, and pushing to create a broader and deeper intellectual base for psychedelics study and research that is just gaining traction.
Heres a quick look at five developments of note among the reported 100-plus U.S. universities researching psychedelics:
Brian Pace, a scholar at Ohio State University who teaches psychedelics studies at the university, and is one of the organizers of the 2022 Psychedemia conference to be held at Ohio State, told Open Foundation, a Netherlands non-profit think tank, that the new-agey, cultish stuff they see around psychedelics now, with tuning your chakras and merging souls or whatever, is their fault. Thats an abdication of the responsibility to investigate interesting questions and to chase down data: to find out how things work, Pace said. So where we are now is a very timid and late re-entry to the subject, more so for education than research. Psychedelic research didnt end when the universities and governments abandoned it. It continued in the underground. The role of the university courses on psychedelics is to identify and evaluate high-quality information on the topic. We have a lot of catching up to do and I think that should be done with humility.
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LSD Is Back On Campus, But This Time It's Approved - Green Market Report
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Mixing mushrooms and alcohol: What you need to know – Medical News Today
Posted: at 10:23 pm
Consuming magic mushrooms (shrooms) and alcohol together can have unpredictable results. For this reason, doctors recommend against combining alcohol and recreational drugs such as shrooms.
Alcohol and shrooms interact because they can affect the brain in some of the same ways. Combining substances that act similarly intensifies the drugs effects, side effects, and potential risks.
Some people may notice that mixing alcohol and mushrooms can lessen the effect of each drug. However, it may also make it more difficult to think clearly.
Keep reading to learn more about the effects of mixing mushrooms and alcohol.
Shrooms are mushrooms that contain psilocybin, a natural hallucinogenic and psychoactive compound. They can cause hallucinations and an inability to tell the difference between fantasy and reality.
Although people usually use shrooms recreationally, they can have adverse effects. People may experience:
Alcohol affects the brain similarly to shrooms. Drinking too much alcohol can change a persons mood and behavior, and it can cause people to have trouble with memory and motor control.
Although doctors generally advise against combining substances, there is limited research showing the effects of shrooms and alcohol. This means most of the effects of mixing them come from peoples reported use.
Combining alcohol and shrooms can cause unpredictable results, but experts consider it a high-risk combination. It can cause headaches, panic attacks, and nausea. Drinking alcohol while taking shrooms can also increase a persons risk of a bad trip, which can include hallucinations and frightening emotions.
Some people report drinking alcohol to lower the effect of shrooms and feel less high. While they may decrease the effects of alcohol, there is limited research supporting this, and the effects can be unpredictable.
It is also unclear how much alcohol is safe in combination with shrooms. Overall, doctors do not recommend consuming alcohol while using other drugs.
Experts also advise avoiding polysubstance use, which means using more than one drug together or within a short time.
Interestingly, researchers suggest that psilocybin, the active drug in shrooms, may help people with alcohol addiction. An ongoing study is currently exploring, in a controlled setting, whether psilocybin can lower the number of heavy drinking days among people living with alcohol addiction.
The psilocybin in mushrooms may have mind-altering effects, and reality can appear distorted. Other effects of mushrooms include:
Psilocybin causes hallucinations because it acts on serotonin receptors in the brain and other parts of the body. Serotonin and psilocybin can both bind to serotonin receptors, so when psilocybin is in the body, it competes with serotonin to bind to them.
These receptors are responsible for controlling our emotions and moods. They also control behavior, learning memory, appetite, and other processes.
Other psychedelics include lysergic acid diethylamide (LSD), mescaline, and dimethyltryptamine (DMT).
When combining psychedelics such as LSD with alcohol, people may also notice that the effects of alcohol are lower than usual. However, like with shrooms, these results can be unpredictable.
Researchers are also studying the benefits of using psychedelics in people with alcohol use disorder (AUD). Another study showed that using psychedelics might lower a persons alcohol intake.
These study conditions do not reflect real-life use of alcohol and psychedelics. In controlled studies, the risk of unsafe behaviors and side effects from illicit drugs is low.
People should note that the United States classifies shrooms as an illegal drug.
With years of evidence from peoples reported use and modern scientific studies, experts confirm that shrooms have low toxicity. They also have a low risk of addiction.
However, people can overdose on shrooms. The side effects of an overdose can include:
Another consideration is the risk of accidentally taking a poisonous mushroom when using shrooms.
The effects of mixing mushrooms and alcohol are unpredictable and may vary from person to person. The following symptoms of alcohol poisoning require immediate medical attention:
People experiencing a bad trip, or a psychologically challenging drug experience, may want to contact a doctor. A bad trip can feel like a sudden and long-lasting side effect of a drug. This may occur when taking shrooms alone or with alcohol.
During a bad trip, people can put themselves or others at risk of harm. Some may have aggressive or violent behaviors. A person who feels concerned about their well-being and the safety of others when mixing mushrooms and alcohol should seek immediate medical attention.
The effects of mixing shrooms and alcohol are unpredictable. While some people may experience a lower effect of shrooms when mixing them with alcohol, this effect is unproven. Someone can experience a bad trip when mixing drugs.
If a person experiences concerning side effects after consuming shrooms and/or alcohol, they should seek medical attention.
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Mycotopia Therapies Partners with Public Policy Specialist PsychedelicsEUROPE to Explore Opportunities in the European Market – GlobeNewswire
Posted: at 10:23 pm
MIAMI, May 02, 2022 (GLOBE NEWSWIRE) -- Mycotopia Therapies Inc. (OTC Pink: TPIA) (the Company), a biopharma company focused on research, technology, and the development of medical psychedelics, announced today a partnership with Brussels-based PsychedelicsEUROPE. Mycotopia Therapies will collaborate with PsychedelicsEUROPE to accelerate its psychedelic research and develop new models of care under the regulatory framework for the medicinal use of psychedelics for mental health in the EU market.
PsychedelicsEUROPE has a team of seasoned public affairs specialists advocating for the establishment of an EU-wide regulatory framework that promotes medicinal use of psychedelic substances to the benefit of patient, while stimulating research under a safe and predictable environment. Europes commercial psychedelic healthcare ecosystem is growing rapidly as innovative research centers, NGOs, and private companies attract ideas, capital, and mainstream support. While the U.S. Food and Drug Administration and public health authorities in other countries have formalized policies on psychedelic medicine, the EU is still formulating its policies for psychedelic substances. PsychedelicsEUROPE strives to be a beacon of innovative mental health care models, while inspiring and accelerating the development of regulations that work for the patient through its relationships with medical professionals, academia, and private sector shareholders.
With ambitious regulatory initiatives, such as the Europes Beating Cancer Plan, or the Pharmaceutical Strategy for Europe, we need to make sure that more focus and funding will be dedicated to innovative mental health solutions, like medicinal use of psychedelics, explains Viktor Chvatal, the Secretary-General of PsychedelicsEUROPE. Mr. Chvatal continued, In Europe, our goal is to raise awareness about existing best practices in other countries amongst the EU policy makers and regulators to speed up the process.
Ben Kaplan, CEO of Mycotopia Therapies, said, We are grateful to be able to have a role in advancing psychedelic therapy across Europe in a way that is consistent with sustainability principles while ensuring patient accessibility. We believe this partnership with PsychedelicsEUROPE will provide numerous opportunities to transform innovation into real treatments for patients across the EU and beyond. With that in mind, we look forward to collaborating with the rich academic and biomedical science community in the EU, as well as its world-class talent, to advance our commercialization efforts on our psychedelic assets.
Mr. Kaplan added, Mycotopia Therapies is continuing to work toward completing the acquisition of botanical psilocybin pioneer, Ei.Ventures. The transaction is moving forward as planned, and we look forward to providing shareholders with additional updates in the very near future.
About Mycotopia Therapies
Mycotopia Therapies focuses on helping you heal and reclaim your life. Your journey of healing is an understanding of the causes and works to mental wellness through psychedelic enhanced psychotherapy, integrated with a professional team of mental wellness practitioners and cutting-edge technology. Psychedelic therapy is a holistic and spiritual approach providing healing and has shown successful treatment for many years. Additional information on Mycotopia Therapies can be found on the Companys website at: https://www.mycotopiatherapies.com.
About PsychedelicsEUROPE
PsychedelicsEUROPE is an innovative mental health association with a global reach, which brings together leading research centers, NGOs, and private companies. Based on scientific evidence, the association advocates for a regulatory EU framework that promotes state-of-the-art therapies, fosters cutting-edge research, and secures lasting solutions for patients. Additional information on PsychedelicsEUROPE can be found on the Companys website at: https://www.psychedelicseurope.org
About Ei. Ventures
Emotional Intelligence Ventures, a company dedicated to research and production of botanical psychedelics, announced a public stock offering using the Reg A+ Framework. Ei. Ventures main differentiator in the space is a self-imposed directive to work exclusively with non-synthetic, plant and fungi-based ingredients for both is psychedelic and non-psychedelic products. https://www.Ei.Ventures
Forward-Looking Statement DisclaimerThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words intends, may, will, plans, expects, anticipates, projects, predicts, estimates, aims, believes, hopes, potential or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Companys research, manufacturing and other development efforts; (ii) the Companys ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Companys products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Companys industry and introduction of competing products; (vi) the Companys ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading "Risk Factors" in 20/20 Global, Inc.s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC's website, http://www.sec.gov.
For Media and Investor Relations, please contact:
David L. Kugelman(866) 692-6847 Toll Free - U.S. & Canada(404) 281-8556 Mobile and WhatsAppEmail: dk@atlcp.comSkype: kugsusa
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Pharmadrug Advances Opthalmology Program with Final Selection of Lead DMT-Analogue to Provide Sustained Control of Elevated Intraocular Pressure for…
Posted: at 10:22 pm
Selection of lead candidate from initial short-list of 6 DMT-analogues
Lead candidate displays superior potency in two in vitro bioassays on two relevant human cell types
In vitro safety and biocompatibility testing using drug-loaded medical device demonstrates tolerability at doses anticipated to be within therapeutic range
Results to be leveraged by filing of Provisional Patent detailing a novel approach to treating primary open angle glaucoma
Initiates plans for second stage of R&D with Terasaki Institute for Biomedical Innovation
Toronto, Ontario--(Newsfile Corp. - May 3, 2022) - PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) ("PharmaDrug" or the "Company"), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce that in collaboration with the Terasaki Institute for Biomedical Innovation (TIBI), has selected its final lead drug candidate from a short list of six N,N-Dimethyltryptamine (DMT) analogue molecules. This decision, based on successful completion of the first phase of the sponsored research agreement, derives from the demonstration of lead candidate superiority as it relates to in vitro potency in two predictive bioassays, a favorable toxicity profile as well as physical, chemical, and metabolic properties necessary to fabricate a proprietary medical device capable of conveniently delivering sub-psychedelic levels of drug to the front of the eye over a sustained period.
With efforts related to discovery and candidate selection now complete, the Company intends to advance its program in primary open angle glaucoma (POAG) by entering into a second sponsored research collaboration with TIBI to undertake 1) mechanism of action studies, 2) optimize medical device drug release characteristics, 3) in vitro host-species justification studies to support, 4) evaluation of drug efficacy in an IND-enabling study of POAG with the goal of providing all necessary support to file an investigative new drug (IND) application with the United States Food and Drug Administration (the "FDA") to conduct clinical studies.
Paul Van Slyke, CSO of PharmaDrug, commented, "We are excited to announce that in collaboration with TIBI, we have successfully completed the studies necessary to elect the Company's lead drug candidate for the treatment of POAG. The next phase of this ongoing collaboration will start shortly and is underlined by the Company's strong commitment to work with outstanding research and development groups from around the world to provide innovative, life changing medications to patients at risk of vision loss as a consequence of insufficiently treated glaucoma."
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Under the terms of the first sponsored research agreement, PharmaDrug's DMT-analogue research program aimed to elect a drug development lead based on biological potency and toxicity and to use the development lead to engineer a medical device capable of sustained drug delivery to the front of the eye. The Company has now selected its lead candidate and completed fabrication and initial testing of its novel medical device designed to deliver therapeutic quantities of its DMT-analogues to the front of the eye. Specifically, drug-loaded medical device prototypes were suspended in a biological solution meant to mimic the somewhat harsh environment of the eye. Samples, maintained at body temperature were removed at defined periods of time over sixteen days and were quantified to determine concentration and rate of drug release and breakdown. Stability of the lead candidate molecule met necessary criteria set forth by the Company. The biocompatibility of drug-loaded medical device was examined by way of quantifying cell proliferation and live/dead staining on human ciliary muscle cells over time. Concentrations expected to be within the therapeutic range were found to not statistically impact cell viability the drug-loaded medical devices.
Most recently, potency of the lead candidate was evaluated in an in vitro cyclic adenosine 3':5' monophosphate (cAMP) production assay using human, primary trabecular meshwork (TM) cells and ciliary muscle (CM) cells. These cells, richly decorated with serotonin receptor 1a and 2a (5HT-1a, 5HT-2a), play a central role in the maintenance of healthy intraocular pressure. Tryptamine molecules, such as the Company's lead candidate are thought to bind to these receptors and elicit downstream biological outcomes which assist in the active drainage (reduction of pressure) of aqueous humor from the front of the eye to the posterior compartment. The Company's lead candidate demonstrated potent cAMP production following application, a statistically significant superiority compared to other candidate molecules examined (p<0001), and an unexpected bias towards cAMP production in TM cells versus CM cells.
Test article potency was previously evaluated using an in vitro calcium mobilization assay on TM and CM cells. Calcium mobilization is understood to provoke smooth muscle contraction, and specifically in the case of TM and CM cells, is thought to contribute to the maintenance of healthy IOP by channeling aqueous humor away from the front of the eye. The Company's lead candidate was found to activate calcium mobilization, to levels that were comparable or greater than the experimental positive control, ionomycin. The lead candidate was also examined for in vitro toxicity and found to be non-toxic to TM and CM cells at concentrations expected to be used in treatment for various eye diseases. Collectively results from the first phase of the sponsored research agreement will be used to draft an upcoming Provisional Patent application which describes use of tryptamine family members, fabricated into a proprietary medical device, to treat conditions marked by elevated intraocular pressure.
The Need for Improved Medications to Treat Primary Open Angle Glaucoma
Glaucoma is a disorder of the optic nerve that results in irreversible vision loss and is the second leading cause of blindness in the world, according to the World Health Organization. Glaucoma impacts more than 2.7 million people aged 40 or older in the United States and current treatments are known to have poor rates of compliance of up to 80% of patients. The global market for glaucoma was estimated by Market Scope at $4.8 billion in 2019 with the U.S. market representing $1.9 billion. Although the exact etiology of primary open angle glaucoma remains poorly understood, and may be variable across patient subsets, it is generally accepted that the observed increase in IOP correlates with progressive vision loss1. Current treatments for POAG primarily consist of eyedrops that can be grouped into three main categories: prostaglandin analogues, carbonic anhydrous inhibitors, and alpha-2 agonists. While these approaches usually provide partial improvement, they often result in side effects such as redness and stinging and require multiple daily applications; all of which diminish patient compliance. Tryptamines, including DMT-analogues are thought to work in a completely distinct way to lower IOP and as such potentially embody a new class of glaucoma medications that may be used alone, or in combination with already approved medications. The Company's streamlined focus on two highly promising, undisclosed tryptamines as a potential therapeutic solution in treating glaucoma represents a potential paradigm shift.
Modulating the serotonin receptor pathway to improve glaucoma outcomes
Key regions of the eye that regulate fluid dynamics, including maintenance of healthy IOP, are known to be richly decorated with various serotonin receptor family members. Previous research has highlighted the role of serotonin receptor signaling in the regulation of IOP2-5. Tryptamines, often hallucinogenic above certain threshold concentrations, constitute a large collection of molecules that selectively act on multiple different serotonin receptors including 5-HT1A and 5-HT2A. Topical application of several different tryptamines have shown early promise in preclinical models of elevated IOP, however formulation, delivery, the potential for undesirable hallucinogenic side effects, and the controlled substances act of 1970 have all contributed to a lack of development of tryptamines to treat this serious threat to vision.
About Terasaki Institute for Biomedical Innovation
The Terasaki Institute for Biomedical Innovation is a biotechnology institute which develops medical devices and cutting-edge protocols for a variety of diagnostic, monitoring and treatment applications. Their research platforms include work in biomaterials, cellular and tissue engineering, wearable biosensors and organs-on-a-chip, with specific expertise in novel polymer development.
About PharmaDrug Inc.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. PharmaDrug owns 100% of Pharmadrug Production GmbH ("Pharmadrug Production"), a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the European Union. PharmaDrug owns 100% Sairiyo Therapeutics ("Sairiyo"), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of infectious disease and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. The Company also owns 100% of Super Smart, a company building a vertically integrated retail business with the goal to elevate the use of functional mushrooms, and psilocybin mushrooms where federally legal, as natural based medicines.
For further information, please contact:
Daniel Cohen, Chairman and CEO dcohen@pharmadrug.co(647) 202-1824
Caution Regarding Forward-Looking Information:
THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
This press release contains "forward-looking information" within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. Generally, forward-looking information may be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "proposed", "is expected", "budgets", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. In particular, this press release contains forward-looking information in relation to: future in vivo efficacy testing in an accepted model of primary open angle glaucoma (POAG), the ability to complete the required studies and obtain regulatory approval, and the impact the Company's potential products will have on treating glaucoma. This forward-looking information reflects the Company's current beliefs and is based on information currently available to the Company and on assumptions the Company believes are reasonable. These assumptions include, but are not limited to the ability of the Company to successfully execute on its plans for the Company and its affiliated entities; the ability to obtain required regulatory approvals and the Company's continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date.
Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company's future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals; risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions; and a deterioration of financial markets that could limit the Company's ability to obtain external financing.
A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company's disclosure documents on the SEDAR website at http://www.sedar.com. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.
Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.
References:
Weinreb RN, Leung CK, Crowston JG, Medeiros FA, Friedman DS, Wiggs JL, Martin KR. Primary open-angle glaucoma. Nat Rev Dis Primers. 2016 Sep 22;2:16067. doi: 10.1038/nrdp.2016.67. PMID: 27654570.
May JA, McLaughlin MA, Sharif NA, Hellberg MR, Dean TR. Evaluation of the ocular hypotensive response of serotonin 5-HT1A and 5-HT2 receptor ligands in conscious ocular hypertensive cynomolgus monkeys. J Pharmacol Exp Ther. 2003 Jul;306(1):301-9. doi: 10.1124/jpet.103.049528. Epub 2003 Apr 3. PMID: 12676887.
Sharif NA. Serotonin-2 receptor agonists as novel ocular hypotensive agents and their cellular and molecular mechanisms of action. Curr Drug Targets. 2010 Aug;11(8):978-93. doi: 10.2174/138945010791591278. PMID: 20426763.
Najam A Sharif & Jesse A May (2011) Potential for serotonergic agents to treat elevated intraocular pressure and glaucoma: focus on 5-HT2 receptor agonists, Expert Review of Ophthalmology, 6:1, 105-120, DOI: 10.1586/eop.10.69
Sharif NA, McLaughlin MA, Kelly CR. AL-34662: a potent, selective, and efficacious ocular hypotensive serotonin-2 receptor agonist. J Ocul Pharmacol Ther. 2007 Feb;23(1):1-13. doi: 10.1089/jop.2006.0093. PMID: 17341144.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/122498
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What Ohios Republican Senate Primary Means for the Future of Trumpism – The New Yorker
Posted: at 10:18 pm
This piece originally appeared in our Daily newsletter. Sign up to receive the best of The New Yorker every day in your in-box.
The staff writer Benjamin Wallace-Wells recently travelled to Ohio to report on the states contentious, high-stakes Republican Senate primary. Ahead of Tuesdays Election Day, the newsletter editor Ian Crouch spoke to Wallace-Wells about the latest developments in the race and what the outcome might tell us about the midterms, the future of the G.O.P., and the state of Trumpism in America.
After months of speculation, Donald Trump endorsed J. D. Vance in the race. But, as recently as Sunday, during a rally, Trump mentioned that his guy J. D. Mandel was doing greatso maybe hes not so invested in the particulars. But how has his official endorsement changed things?
Its organized the race without deciding it yet. J. D. Vance has very clearly received a bump. Also pretty clearly, the only real Trump-skeptical candidate in the race, a millionaire named Matt Dolan, received a big bump, too, and is now running second or third in recent polls. Broadly, the whole month of primaries is a really high-stakes test for how much control Trump still has over the Partywhich is obviously important for Trump but also important for the rest of us because of how direct his challenge to liberal democracy remains. Right now, this fundamental thing about American democracy is being tested, which is: Is this whole party behind Trump or not? And you can see evidence pointing in both directions.
Have the candidates in Ohio been made to submit to a kind of Trump-2020-election-claims litmus test?
At the debates, all the candidates have been asked in a kind of pro-forma wayand this is true across many different Republican state primarieswhether they agree with some statement about the validity of the 2020 election. Whether Joe Biden won it legitimately or if it needs to be investigatedthat kind of thing. Four of the five major candidates in the Ohio Senate primary said they thought the election was stolen, in various words. Dolan was the only one who said no, and said that this was a very bad direction to be taking the Party and the country in. And I think thats really the thing that has made him stand out.
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I dont want to overstate Dolans chances, but, in a race in which all the other candidates have been falling all over themselves trying to get Trumps endorsement, its interesting that there is still some segment of the Party that is excited by someone who stands up to Trump.
As you write in your article, most of the candidates in the Ohio primary ran as some slightly different version of Trump. From what youve seen, what kind of new hybrid strain of Trumpism is going to be the most effective heading into the midterms this fall?
The idea of what Trump meant that was most popular at the outset of the primary season is the one embodied in Ohio by Josh Mandel. It was the idea that Trumpism represented a license to be cruder and more aggressive and more partisanwithout any particular change in conservative policies or aims. To talk in a more Trumpy way about immigrants and newcomers, toeing the line and sometimes crossing it with racism. To just be more crass in your language and the way you describe your opponents, and to run a nastier campaign.
What Vance represents is perhaps a more interesting proposition, which is to embrace the ideas that Trump sometimes talked about and sometimes didnt, but that got caught up in Trumpism, of anti-litisma politics that organizes itself against corporations rather than for them, against lites here and overseas, against traditional American diplomatic commitments. Vance represents a more doctrinaire America Firstism, which in some ways is traditional Republican politics on steroids and in other ways departs from those traditions. In terms of economic interests and commitments, Vance, even clearer than Trump himself, seeks to break with traditional Republican ideas.
Then there is Mike Gibbons, a candidate whom one opposing political consultant described to me as a sloppy plutocrat, an older businessman who tried to buy his way to the front of the race. He represents the idea that what had been essential about Trump was that he was an outsider and a businessman.
Last of all is Jane Timken, who had a kind of disastrous candidacy and who basically just seemed to understand Trumpism as being about the specific people around Trump. She hired as her consultants Corey Lewandowski, Kellyanne Conway, and David Bossiea bunch of people who were very close to Trump specifically. Thats also a live idea in the Republican Partymaybe Trumpism didnt really mean anything except the ascendancy of a very specific group of people close to this one man.
In different states with different candidates taking up these different strains, you might have a different outcome. What this pattern in this race does show, though, is that the question of what Trumps dominance over the Party has meantand what it derives from and where it goesis still totally up for grabs.
There is special fascination with Vance in the pressin the years leading up to Trump, he was kind of identified as this wise whisperer of the disaffected white, conservative mind. But now hes completed a full heel turn against establishment entities, including the media. What do the Ohioans youve spoken with make of him?
I think the answer might have been a little different before he got Trumps endorsement. Before, he was viewed as something of an interloper. There were attacks on him that noted he hadnt spent a lot of recent time in Ohio. He was branded as a product of Yale Law School and the part of the media that drives book sales. The amount that his reputation seems to have turned after the Trump endorsement is at least some evidence of the power that Trump still has to define who is a conservative and what it means to be one.
Vance himself has become a very effective promoter of his views on conservative media and a pretty adept user of Twitter. It seemed for a while that he was becoming a more generic culture-warrior type, just a version of Tucker Carlson in the race. After seeing him on the stump, I thought that that was not really a complete picture. I think he sees the decay of culture and community in Ohio, specifically in rural Ohio, and places the blame at the feet of powerful economic and cultural institutions. I think thats all there, that its sincere. I dont think its just a type of culture-war posturing. It was interesting for me to see him campaigning and to see that those themes that have been woven through his writing and politics for several years are still present. He hasnt been quite as flattened as you might think from reading Twitter.
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What Ohios Republican Senate Primary Means for the Future of Trumpism - The New Yorker
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How Republican Primaries Are Testing Trump’s Influence : 1A – NPR
Posted: at 10:18 pm
Former president Trump has endorsed candidates running in at least 40 primary races in May. Drew Angerer/Getty Images hide caption
Former president Trump has endorsed candidates running in at least 40 primary races in May.
The Ohio primary kicks off a month of similar contests in vital swing states from Pennsylvania to Georgia. And there's one unofficial candidate on the ballot: former President Donald Trump.
According to a New York Times count, the former president has endorsed candidates in at least 40 Republican primaries. His pick for Ohio's crucial open Senate seat is J.D. Vance, author of "Hillbilly Elegy." He's one of seven candidates. Only one candidate in that race has denied Trump's falsehoods about the 2020 election.
It's common theme among a majority of the Republican candidates. According to focus groups conducted by GOP strategist Sarah Longwell, roughly 70 percent of voters are leaning into the "Big Lie" as well.
So what's at stake for the Republican Party in these midterms? And how will Trump's picks fare at the polls?
Gabby Orr, Alison Dagnes, and Sarah Longwell join us for the conversation.
Like what you hear? Find more of our programs online.
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How Republican Primaries Are Testing Trump's Influence : 1A - NPR
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Wide divide: Split in the Republican party sets tone for upcoming elections – WXYZ 7 Action News Detroit
Posted: at 10:18 pm
CHESTERFIELD TOWNSHIP, Mich. (WXYZ) This is a critical election year. Michigan residents will be deciding who is governor, attorney general and secretary of state for the next four years.
Even if youre passive about politics, whats happening now is driving this election year and your choices.
The stage is set by Former President Donald Trump, who is endorsing Matthew DePerno for attorney general and Kristina Karamo for secretary of state.
That started the wide divide.
"I have not promised President Trump anything," said DePerno.
Karamo said, "President Trump endorsed me; it was not because I was looking or promising to do something immoral, illegal or improper. Nothing like that occurred."
Republican campaign strategist Jamie Roe said we need to have the best team on the field, but added, I think that we could have had a better team."
The wide divide played out big time at the Republican delegates convention with voting for the Trump-backed candidates.
"I've been active in the party for over 25 years," said Chesterfield Township Clerk Cindy Berry.
Berry was Trumps 2016 co-chair in Macomb County. She was a candidate in Michigan for secretary of state.
7 Action News asked Berry why she thinks she was pushed away from the position.
That's a great question. I'd love to know that. I don't see how anyone could have been more Trump than me, Berry said.
It's because she's not all-in that the 2020 election was stolen from Trump.
His two hand-picked candidates are calling for a full investigation even though last year, the Republican-led state Senate Oversight Committee did a thorough review statewide and found no widespread fraud. The committee chair was Senator Ed McBroom.
He's a Republican, he comes out with that and he gets called a RINO? Right? Kiertzner asked. "And I was called the RINO as well simply because I wouldn't get on board with the narrative. And it wasn't that I was opposed to looking at it. I'm certainly not opposed to doing any investigation, Berry said.
"In a nutshell, his investigation was total garbage," said DePerno.
Karamo said, "I feel there's been no meaningful investigation into the 2020 election. And again, there is evidence of election fraud that was ignored, mocked, and demonized. And that's my position."
RINO means Republican In Name Only, a favorite term of Trump and his supporters.
Ive been working to elect conservative Republicans for over 30 years, Roe said. I'm not going to be called a RINO by anybody, particularly people who Id never heard of before a couple of years ago.
DePerno said, "I think all of these incumbents need to put on their big boy pants and come to the table and support the endorsed candidate. Acting like children only means we are going to lose in November. Maybe thats their goal."
Trump has a firm grip on northern Macomb County.
The convention in Grand Rapids was led by Trump loyalist and Republican co-chair Meshawn Maddock.
We asked her for an interview for this report. She said it probably wasnt a good idea.
Trump has a firm grip on northern Macomb County. How will this all play out in the months ahead? We talked with voters at the Jams Restaurant & Bar and found mixed support for Trump and the Stop the Steal movement.
Obviously, him being the last Republican president does have some leeway, but I wouldn't say it's super important, Zack Kaiser, who leans Republican, said.
Carol Russell, who supports Trump, said, I think he has the right to do it.
Russell says that would not determine how she votes.
Its nonsense sheer, unadulterated garbage, Syma Echeandia, who does not support Trump, said.
Party loyalists say Republicans need to be focused on the issues of taxes, roads and inflation.
Re-litigating the 2020 election doesnt help us stop any of the bad things that are going on right now. And in fact, its a distraction from the real problems that were facing in this state and in the country, Roe said.
We reached out to the Democratic party chair to comment but did not hear back.
Gov. Gretchen Whitmer, a Democrat, is running unopposed.
I know theres been a lot of chaos. I dont pay a whole lot of attention to it, Whitmer said.
The Republican candidate for governor wont be decided by voters until August.
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