Category Archives: Psychedelics

A new study has compared the effects of varied doses ofpsilocybin and LSD for the first time. These two popular psychedelics have been of increasing interest in clinical research. The new paper, which detailed a double-blinded, randomized and placebo-controlled study of 28 healthy volunteers, compared the impact of placebo, LSD (100 and 200g) and psilocybin (15 and 30mg). The study was a collaboration between the Liechti Lab at Switzerlands University Hospital Basel and MindMed, an established player in the psychedelics drug development industry.

Technology Networks caught up with Rob Barrow, CEO of MindMed, to discuss the findings in more detail and explore pressing issues around blinding in psychedelic drug development.

Barrow spent 10 years as the chief operating officer of a clinical stage private pharma company before joining the psychedelic non-profit Usona Institute, followed by a move to MindMed in 2020. Barrow says that his vision for MindMed was of a psychedelics company that can operate at scale and juggle multiple assets. It's an ambitious goal. In this interview, he discusses how this aim has been realized in 2022.

Ruairi J Mackenzie (RM): How are doses in psychedelic drug studies decided upon and measured?

Rob Barrow (RB): As in most drug development programs, dosing is one of the key aspects you need to fully characterize throughout early development. When you go into your pivotal phase III studies, you need to have your dose nailed down. There are a number of elements that can factor into dosing on an individual basis, but you're arriving at a dose that you feel is reliably going to induce the pharmacology that you want, to lead to the clinical outcomes that you're seeking to provide to patients.

When we think about dosing with psychedelics, there has been, fortunately, decades of research to well characterize the pharmacokinetics and dynamics and we really have a good understanding of how those interactions play out.

To have a drug that you can bring out to market at scale, you typically end up at a fixed dose regimen unless there's a particular concern, often more of a concern for safety, which tends to not be the case with this drug class. Most of the studies look at metabolic phenotyping and genotyping and drug-drug interactions with LSD; all these things are important in terms of labeling. But often it's not the case that they're labeled for an efficacy or pharmacodynamic reason, they're labeled because of safety. When you think about psychedelics, at this point we feel like we're confident enough in the safety that we are aiming for a fixed dose regimen.

We have launched a phase IIb dose optimization study of LSD. That's really to explore which of those fixed doses reliably gives you the activity that you're seeking to generate both acutely, but also more importantly, in terms of clinical outcomes over the course of several weeks.

RM: You compared LSD and psilocybin doses in a new study. What were the key findings?

RB: The key finding is that LSD is much more potent than psilocybin (which we knew previously) but also that it does appear to induce the same acute psychoactivity and acute perceptual effects as psilocybin. What we don't know this is the key question that remains from this work what we aren't certain of is whether that acute activity directly modulates the clinical response. Whether the acute, perceptual effects are directly causative to antidepressant or anxiolytic effects of these molecules. Nonetheless, we certainly think that this study provides a solid evidence base to allow us to read across the assets.

As we look at data from psilocybin, it gives us increased confidence that we can learn from those results and that they would be applicable to LSD, for instance, which gives us an enormous additional opportunity to learn from research outside of our own programs. And it continues to de-risk our approach and give us more opportunities for expansion of our label and where we might go with marketing one day if we get these therapies approved.

RM: Were these results surprising to you?

RB: It wasnt terribly surprising, given the thousands of patients that have been administered LSD and psilocybin, and anecdotally, you can certainly look at the evidence and say, these are going to behave similarly. But it's important to definitively establish these things. Having scientific evidence to link the two is much more valuable than just anecdotal observation. At the end of the day, its not particularly surprising that there's quite similar activity.

One remaining question is, based on the differences between LSD and psilocybin, and based on the doses that we are exploring between the two molecules, does LSD more reliably induce a certain response at a certain dose? There's a lot more to be discovered about that translation in terms of clinical activity.

This was not done in a population with a diagnosis. We need to understand if there's a similar response in the clinic or how they differentiate. Some of the observational evidence we have from our colleagues who have been working with LSD for a long time is that it very well may be even better at treating the clinical outcomes. Now, we have to prove that.

RM: Theres been a lot of discussion in the field recently about the issue of blinding in clinical trials. In your new study, which was double-blinded, participants were able to guess whether they were taking a drug or a placebo96% of the time. What are the ways forward to try and minimize these issues with blinding?

RB: Its a fascinating topic, I've personally had a lot of interesting engagement, both with researchers and the FDA about this. The FDA and other researchers have preferences in terms of what we're using as control conditions; niacin has been offered up many times, some studies have used diphenhydramine. At the core, the reality is that it is going to be very difficult to fully blind LSD or psilocybin in a two-armed randomized controlled study. We're doing this study with four active doses of LSD plus a placebo. That probably gives you the best quality of the blind if you're looking at dose response, because it's going to be harder to differentiate 50 g from 100 g or 200 g, and 100 g from 200 g. That gives you some complexity that will aid in blinding, but in a two-arm study, it's going to be very difficult.

That said, it's also important for us to not forget that this is not a unique problem to psychedelics. If you look at think of any other CNS-active drug, very often, there is a clear perceptual effect that is going to make it more difficult to blind.

That may be more profound with psychedelics. But consider ketamine, which is a dissociative agent. If you look at the adverse event tables for esketamine versus placebo in the esketamine approval [esketamine is one of the two molecules that make up the racemic mixture of ketamine and was approved by the FDA for treatment resistant depression in 2019], the rate of dissociation in the esketamine arm was many-fold higher than in the placebo group.

RM: Two years is a long time in psychedelics research how do you feel MindMed has moved closer to your goals of making psychedelic research more high-throughput since you joined?

RB: Weve been building substantially over the last year. When I came into the organization, we had only about 10 employees and now we're at about six times that. We've been bringing in the talent and the people from pharma who know how to build big organizations and how to take on challenges in a scalable way and take on multiple programs at the same time. We have been absolutely delivering on that vision internally. In drug development, clinical trials do take a long time, this is just the reality of any development program is that a single trial can often take several years. Were still in a phase where we're continuing to build and have announced new programs over the last year. We also have a number of the studies with our collaborators in the Liechti lab at University Hospital Basel. There are a number of studies they have ongoing with LSD and other indications with other molecules. These give us good evidence to make decisions about how well continue to grow and how we think about potential label expansion and new programs. All of that has been progressing very well.

As we look out over the next year or two years, there are going to be many data sets coming out that are going to be quite informative to us and to the wider world about where the potential lies with LSD and where we think other molecules may fit into the pipeline.

We added a program in the second half of last year, which is the R-enantiomer of MDMA for treatment of autism spectrum disorder. We're making sure to remain laser focused on executing what is in front of us and what we've already taken on, but we are continuing to see an enormous opportunity and one that spans far beyond just a single asset and a single indication and we're continuing to make advancements across all our programs to achieve that goal.

Rob Barrow was speaking to Ruairi J Mackenzie, Senior Science Writer for Technology Networks

Read the rest here:

Behind the Scenes on the First Study To Compare the Effects of LSD and Psilocybin - Technology Networks

VANCOUVER, British Columbia--(BUSINESS WIRE)--REVITALIST LIFESTYLE AND WELLNESS LTD. (Revitalist or the Company) (CSE: CALM) (OTCQB: RVLWF) (FSE: 4DO), one of the largest publicly listed US based ketamine clinic operations, is pleased to report updates on strategic initiatives accomplished in April including becoming a founding partner with the American Association of Psychedelics.

Revenue April 2022 sales of approximately $480,000 CAD represented a 319% increase from the same month in 2021 and a 15% increase compared to March 2022.

Insurance Over 80 medical and mental health providers directly associated with Revitalist have now been accepted and considered to be in-network with top commercial insurance payers including Blue Cross Blue Shield, Aetna, Cigna, Humana, Optum, United Healthcare, and federal insurers including Veterans Affairs Community Care Network and Medicare. In network verifies the providers have met the insurers quality standards giving greater financial security to consumers and payers.

Research Revitalist receives acceptance to present at the American Psychiatric Nursing Associations National Conference discussing its findings on Case Report: Adult with Bipolar Disorder and Autism treated with Ketamine. To request a copy of this report, please email us at corporate@Revitalist.com

Education Revitalist becomes founding partner with the American Association of Psychedelics. The inaugural conference, Ethics Safety, Science takes place in Knoxville, TN, November 17-20, 2022. To learn more visit AAPsychedelics.org

Metaverse Revitalists partnership with Metachain Technologies Inc. to create virtual mental health and wellness clinic chains through its subsidiary, Revitaland, enters alpha testing phases.

CEO Speaking Engagements Gatherverse Mental Wellness Summit, May 24-25, Virtual Conference, gatherverse.org

H.C. Wainwright & Co Global Investment Conference, Miami, FL, May 23-26, 2022,https://hcwevents.com/globalconference/

Athletes Unite Conference, Atlanta GA, July 15 & 16,http://www.shakeoutllc.com/athletes-unite-conference2022

American Psychiatric Nursing Association, Long Beach, CA, October 19-22,https://www.apna.org/apna-annual-conference/

American Association of Psychedelics, Knoxville, TN, November 17-20AAPsychedelics.org

Treatment Center Investment and Valuation Retreat, Phoenix, AZ, December 5-7https://www.treatmentcenterretreat.com

Revitalist CEO, Kathryn Walker, states: April was a terrific month for the Company. We closed the first tranche of our financing for $3,869,000 and ended the month with our best sales performance yet. Considering the barriers many companies are facing at this time with inflation and market fluctuations, this proves the strength of our company even in trying times. I am continuously amazed as we continue to trail blaze this industry executing at accelerated speeds in various revenue producing capacities changing and saving lives every day.

ABOUT REVITALIST LIFESTYLE AND WELLNESS LTD.Revitalist Lifestyle and Wellness Ltd. (CSE: CALM) (OTCQB: RVLWF) (FSE: 4DO) is one of the largest publicly listed, ketamine focused clinic operations operating in the United States. Revitalist proudly offers hope to patients suffering from treatment resistant pain and mood conditions through ketamine assisted psychotherapy (KAP). Each clinic enables access to psychedelic medicine, vitamin infusions and other lifestyle optimization services provided by medical professionals, mental health experts, and chronic pain specialists. Since opening their first clinic in 2018, Revitalist has provided thousands of ketamine infusions through its network of 9 clinics operating in 6 states. Its founder and CEO, Kathryn Walker, has witnessed firsthand the transformative impact of KAP and intends on offering other psychedelic treatments as they become available. For additional information and to be added to the Companys mailing list, please click here.

Twitter: @RevitalistCorp Facebook: @RevitalistLifestyleandWellnessLtd.Instagram: @RevitalistCorp LinkedIn: @RevitalistLifestyleAndWellnessLtd

On Behalf of the BoardKathryn WalkerChief Executive Officer

Forward Looking StatementsThis news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Revitalist to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release.

Risks, uncertainties, and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Read the rest here:

Revitalist's Strategic Initiatives Continue to Exceed Expectations for Execution Giving Company Record High Revenues Since Opening in 2018. - Business...

In the cold dark streets with tears streaming down his face, he sought them out, but he was really in search of something more solace from the post-traumatic stress disorder hed acquired while serving in a combat zone in the United States Army.

Until recently PTSD wasnt well understood. Until very recently it wasnt taken seriously. There werent many options for people like Lubecky, who had been home from Iraq for less than 60 days.

When Lubecky finally found the bells of Sacred Heart, the century-old neo-gothic cathedral was so full that he was turned away.

He lingered near the North Carolina Veterans Monument for a time, staring up at the solitary white obelisk of Mt. Airy granite topped by a dark bronze Lady Liberty hoisting a tobacco leaf high above her head.

He was trying to figure out the best way to kill himself.

Something from his training popped into his thoughts, so Lubecky hopped in his car and drove to the Womack Army Medical Center at Fort Bragg.

He told them he wanted to take his own life.

They gave him six Xanax and said not to take them all at once or he would succeed.

Instead Lubecky drove home, downed a fifth of vodka, put a Beretta to his temple and pulled the trigger.

More than 15 years later, an estimated 22 American veterans still commit suicide each day as thousands more are left searching for something Jonathan Lubecky couldnt find on that Christmas Eve.

Stigma associated with seeking mental health assistance and a general lack of education about PTSD both contribute to the death toll, as do palliative treatments that dont nearly help all of the people all of the time.

That may soon change, and Western North Carolina is at the tip of the spear thanks to a promising new treatment that involves an overlooked psychedelic compound called MDMA.

Jonathan Lubecky, seen here outside the White House in 2019, continues to advocate for increased access to psychedelics like MDMA for PTSD patients. Donated photo

Miraculously, Jonathan Lubecky didnt die on Christmas Eve in 2006. A manufacturers defect in the cartridge prevented the round from leaving the barrel.

You still get a bang, Lubecky said. And I did it in front of a mirror. I thought I was dead. And I was like, This is what dead is?

Born in Ohio, Lubecky reported to Marine Corps Recruit Depot, Parris Island nine days after graduating high school in 1995 and served as a C-130 loadmaster until he left the Marines in 1999. He returned after the Sept. 11 terror attacks, and was sworn into the North Carolina National Guard three days after the initial invasion of Iraq in 2003.

Iraqs Balad Air Base, where Lubecky was stationed in 2005 and 2006, was the target of thousands upon thousands of mortar attacks. Each and every day, Lubecky said, the dry desert air rained steel. Sirens blared. Soldiers scrambled. Defensive weapons roared as explosions peppered the base, leaving the distinct smell of cordite wafting over them all.

Theres also one specific incident Lubecky doesnt want to talk about.

Then, as he prepared to return home in late 2006, his life rapidly became a country music song.

His wife took their dog, sold his motorcycle and moved in with another man, leaving him only an empty house in Sanford, not far from Fort Bragg.

Occasionally you could hear helicopters flying overhead or impacts from artillery. When I started hearing those and they werent there, he said, I realized I was starting to have a problem. Things devolved rapidly from there.

Thats what led Lubecky, weeks later, to that lonely Christmas Eve at the bar and the church and the monument and the hospital and his face in the mirror with a gun against his head.

It was his first suicide attempt, and hed try four more times over the next eight years, all the while still searching.

They had me on I think a total of 42 pills a day for mental health and chronic pain and stuff like that, said Lubecky of his experience with the VA. And then on Nov. 4, 2013, I slit my wrists, which was my final suicide attempt.

The history of ineffective treatments for PTSD parallels the history of PTSD itself. First described by the ancient Greeks, PTSD has been known for millennia by different names shell shock, war nerves, combat neurosis, soldiers heart.

Its not limited to combat veterans or veterans in general and can affect anyone whos been through acute or chronic trauma, be it emotional, physical or sexual.

Roughly 12 million Americans are walking around with PTSD in any given year, according to the U.S. Department of Veterans Affairs .

Civilians experience comparatively less trauma than members of the armed forces. Studies from the VA suggest that 15% of Vietnam veterans, 12% of Gulf War veterans and somewhere from 11-20% of veterans from operations Iraqi Freedom and Enduring Freedom have PTSD.

In 2019, about 17 civilians per 100,000 committed suicide, while the rate for veterans was closer to 27.

Jonathan Lubecky may have continued on his path to becoming one of them, but after his last unsuccessful suicide attempt, someone at the Charleston VA slid a folded up note across the table, told him not to tell anyone about it and not to open it until he got home.

Published data suggest that MDMA has value as a post-traumatic stress disorder treatment. Multidisciplinary Association for Psychedelic Studies infographic

In his Waynesville office, the bearded, bespectacled Dr. Raymond Turpin sits behind a modest desk piled with papers, folders and a webcam. The place screams calm, with soothing natural light streaming through the partially drawn window shades, casting sepia hues over the rich wood trim.

Strewn about the high-ceilinged room are several chairs and couches where patients of the Pearl Psychedelic Institute come to discuss their trauma with Turpin.

A Georgia native, Turpin was an advertising major at the University of Georgia in the mid-1980s until he had his first encounter with psilocybin, the active ingredient in hallucinogenic mushrooms. The experience led him to change his major to psychology and earn a masters degree at West Georgia College, and then a PhD at the California Institute of Integral Studies. He moved to Waynesville in 2001.

All along, Ive been interested in psychedelics as medicines and being used for mental health treatment, Turpin said.

Psychedelics are a class of compounds that trigger dramatically altered states of consciousness. Natural psychedelics like peyote and psilocybin have been known to humans for thousands of years and were sometimes utilized in religious or spiritual ceremonies.

Recreational users also consumed them for the pleasant physical and emotional effects they can produce, alongside auditory and visual hallucinations.

More than a century ago, the pharmaceutical industry began to study these compounds and isolate or synthesize new ones, hoping to find some commercial use for the relatively potent substances.

Swiss chemist Albert Hoffman first synthesized LSD in 1938 but experienced the psychedelic effects firsthand on April 19, 1943 now called Bicycle Day , because of Hoffmans interesting ride home from work. Bicycle Day is also recognized as the dawn of the modern psychedelic age.

Wayne State University professor Dr. Calvin Stevens invented ketamine in the early 1960s, which ended up being a go-to surgical anesthetic on the battlefields of Vietnam. Now, its an FDA-approved nasal spray that treats depression.

MDMA, discovered by Dr. Anton Kllisch of Merck Pharmaceuticals in 1912, sat on a shelf until a Dow chemist named Dr. Alexander Shulgin rediscovered it in 1976, and began testing it on himself.

Through ever-increasing dosages, Shulgin eventually experienced the psychoactive effects of MDMA and suggested to his friend, Oakland psychologist Leo Zeff , that it might be good for psychotherapy.

Dr. Raymond Turpin sees hope in a new treatment for PTSD. Jeffrey Delannoy photo

At one time, Turpin said, there were around 4,000 mental health professionals legally using MDMA in their psychotherapy practices.

But MDMA had also been adopted by the early-1980s underground party culture, where it was used recreationally as a supplement to the loud music, colorful flashing lights and gyrating revelers.

Users reported feelings of euphoria, increased energy, sensory elevation and tactile stimulation that earned MDMA the moniker of ecstasy, or simply, X. More recently, its been called Molly.

Blowback ensued, and by 1988, MDMA was classified as a Schedule I narcotic by the U.S. Drug Enforcement Agency, along with heroin, LSD, marijuana, methaqualone (quaaludes) and peyote. Schedule I substances are defined as drugs with no currently accepted medical use and a high potential for abuse.

In the mid-1990s, Dr. Charles Grob of UCLA received FDA permission to conduct the first phase-one study on the physiological and psychological effects of MDMA in healthy volunteers.

Other than a temporary elevation in heart rate and blood pressure, and maybe body temperature, people could tolerate it well and there werent any adverse effects, Turpin said. That opened the door to phase two, which was where they actually started to look at it for PTSD. And there was a lot of evidence from the legal period there during those 10 years in the late 1970s/early 1980s that it might be very effective with people who had traumatic histories.

In 2017, Turpin returned to the California Institute of Integral Studies for a certificate program in psychedelic studies and research, where he met Dr. Michael Mithoefer and his wife Annie , a registered nurse. Mithoefer conducted one of the seminal phase two studies testing MDMAs suitability for treating PTSD.

The results were really pretty strong, said Turpin. These were folks that had severe chronic PTSD for an average of 17 or 18 years. One year after the protocol, 67% of the people that had entered the study with PTSD no longer qualified for [a diagnosis of] PTSD.

When Lubecky got home, unfolded the note and read it, it simply said, Google MDMA PTSD.

Once he did, he learned that the Multidisciplinary Association for Psychedelic Studies was conducting a phase two clinical trial, run by the Mithoefers. Founded in 1986, MAPS is a 501(c)(3) nonprofit focusing on the development of cultural, legal and medical shifts in the careful use of psychedelics for mental and spiritual healing.

Interestingly enough, I returned from Iraq on Nov. 22, 2006, and I took my first dose of MDMA on Nov. 22, 2014, Lubecky said. So, on Nov. 22 of this year, I will have been healed of PTSD as long as I had it.

But its not as simple as just taking a single pill and walking away feeling better.

Theres a strict screening process meant to weed out people who could experience an adverse reaction from MDMAs known side effects elevated blood pressure and heart rate. Then, there are three 90-minute prep sessions where therapists get to know the patient and answer questions about the treatment.

Next comes the dosing session, during which two therapists administer the drug via a pill and sit with the patient for between six and eight hours. Sometimes the patient will don eyeshades, or headphones, and listen to calming instrumental music. Other times, theyll talk with therapists as they go through the experience.

It kind of felt like I was in a tight wetsuit in a hot tub, Lubecky said. Its like doing therapy while being hugged by everyone in the world who loves you in a bathtub full of puppies licking your face.

The patient will go on to spend the night and then participate in an integration session following breakfast the next morning, trying to make sense of what was happening during the dosing session.

Typically, three dosing sessions followed by integration sessions will take place over the course of four to six months. After that, no further MDMA use by the patient is anticipated.

Whats actually happening during those dosing sessions is the untangling of complicated processes in the brain that have become dysfunctional due to trauma.

When somebody is undergoing an overwhelming psychological emotional experience, certain higher functions of the brain shut down, and the brain reverts to more primitive processing, Turpin said. The information thats coming in from the traumatic memory the things people are seeing, what theyre hearing, what theyre smelling they dont go through proper processing channels, like a normal memory would. It basically gets stuck in the brain in an improper area where it just sits there. And thats why people have intrusive memories, nightmares, flashbacks. Its all this highly charged, fragmented information.

That information tends to pop up randomly, or when external sensations trigger a re-experiencing of the traumatic event.

Its just kind of living in a state of fear, said Turpin. There could be a car backfiring. They could smell somebodys cologne that reminds them of the smell of the person that raped them. It tends to really throw the body into a state of shock almost.

Such episodes can leave those suffering from PTSD with hypervigilance, but they can also result in the desire for physical seclusion and mental isolation with or without the use of alcohol or other illicit drugs.

The only two FDA-approved drugs for the treatment of PTSD, Paxil and Zoloft, are antidepressants and dont really treat the underlying cause of PTSD. Theyre often prescribed in conjunction with other drugs to combat the effects of PTSD, like sleeplessness and nightmares.

A 2009 study pegged their effectiveness at between 20-30%, although Turpin said its maybe 50% at best.

What weve done for years in treatment is try to give people drugs that have tried to basically throw a blanket on those symptoms and to mitigate those symptoms so that people can go out and function, Turpin said. Unfortunately, we havent done a very good job with those drugs.

What MDMA does, according to Turpin, is shut down the amygdalae the fire alarm of the brain that triggers the normal fight-or-flight response to trauma. That allows the trauma to be processed by the prefrontal cortex, the way it should have happened in the first place.

The positive results from Mithoefers phase two trial, in which Lubecky was a participant, led to the third phase of trials conducted by MAPS .

I think theyre expected to probably do phase three through this year and then wrap it up and turn in hopefully a new drug application to the FDA early next year, Turpin said. The hope is that itll be approved, but theres a special program that the FDA has, called expanded access or compassionate use.

The FDA has approved 10 sites nationwide for the compassionate use program, effectively clearing the way for 50 people to receive the MDMA treatment. Four sites are expected to be up and running soon, but Turpins Waynesville practice has a bit of a head start on the other three.

Mithoefer was my mentor for that [certificate] program, and they were moving to Asheville, Turpin said. Thats how the conversation got started about maybe getting an expanded access site in Asheville, and since I was over here in Waynesville, I was kind of interested to see if we could pull it off in Waynesville, too.

Currently, two patients are in the screening process and on track for treatment later this year, which would make Waynesville the first expanded access site in the world for the compassionate use of MDMA to treat PTSD.

Ill be honest, Lubecky said. I didnt think this was going to work. Thats entirely why I volunteered. Im like, Im going to die any day, I might as well try this. And then it was a miracle.

Marine Michael Ferguson (left) rides out of Fallujah after 28 days of near-constant firefights. Donated photo

Lubecky hasnt taken MDMA since his initial doses in 2016 and continues to advocate for the treatment he thinks saved his life, which is good news for other veterans like Waynesville resident Michael Ferguson, who hasnt yet had the opportunity to go through the MDMA treatment process.

Ferguson joined the Marine Corps just before the terror attacks of Sept. 11, and became part of a FAST company Fleet Anti-terrorism Security Team.

After the invasion of Iraq, he spent 28 days fighting in the Battle of Fallujah.

Fallujah was kind of, firefight, break. Firefight, break. Youd hear morning prayer about 5 a.m. and youd know everybody was getting up and pretty soon they were going to come find where you are today. At times I remember being on rooftops and looking out over the city and it looked like the entire city was on fire, Ferguson said. Its hard for me to explain it or put it into words and grasp it. Its still odd to me that thats what I did.

Ferguson said he had trouble adjusting when he returned home and was fired from his first nine jobs for his quarrelsome behavior. He still sees snipers lurking in open windows and improvised explosive devices on the sides of Western North Carolinas roads.

Finally, a Vietnam veteran recognized Fergusons symptoms and encouraged him to visit the VA. From 2006 until he was formally diagnosed with PTSD in 2014, he went through several different therapy programs and was on 11 different medications.

I never really found one that even came close to working. Most of what I was given at the time had a side effect of suicidal ideation, he said. Thats the last thing that a person in my position needs is more encouragement towards that.

Ferguson stopped taking medications for PTSD several years ago. He said he still contemplates self-harm but continues to fight it, in hopes that one day soon hell find the solace that Lubecky found perhaps in the research and treatment Turpin and MAPS are currently conducting. When you deal with death that much at such a young age, once somethings on the table, its hard to remove it off the table, he said. Even today I definitely dont have an intent or a will [to commit suicide] but its still something I think about. Its always going to be on the table. The process is just keeping it on the table and not putting it into action. And every day that we do that, we win.

If you or someone you know is contemplating self-harm, call the National Suicide Prevention Lifeline at 800.273.8255. The work of MAPS and the Pearl Psychedelic Institute, both of which are nonprofits, is primarily funded through donations. To learn more or to help, visit pearlpsychedelicinstitute.org/donate.

Go here to read the rest:

MDMA as medicine: Stemming the tide of veteran suicides in Western North Carolina - Smoky Mountain News

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

See original here:

Cybin's CYB0004 Shows Positive Preclinical Results Over ...

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."

More:

Psychedelics played role in Wallace Falls hiker's death ...

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."

Go here to see the original:

The Mainstream Healthcare VCs Dipping Their Toes Into Psychedelics - Business Insider

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.

Post Views:927

Follow this link:

LSD Is Back On Campus, But This Time It's Approved - Green Market Report

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.

Original post:

Mixing mushrooms and alcohol: What you need to know - Medical News Today

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

The rest is here:

Mycotopia Therapies Partners with Public Policy Specialist PsychedelicsEUROPE to Explore Opportunities in the European Market - GlobeNewswire

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."

Story continues

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

More here:

Pharmadrug Advances Opthalmology Program with Final Selection of Lead DMT-Analogue to Provide Sustained Control of Elevated Intraocular Pressure for...