mgland
4年前
Pharmadrug's Supersmart Launches Psilocybin Online Retail Platform in the Netherlands
8:49 am ET June 7, 2021 (Newsfile) Print
Toronto, Ontario--(Newsfile Corp. - June 7, 2021) - PharmaDrug Inc. (CSE: BUZZ) (OTC Pink: 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 its Super Smart division has launched a Slim Winkel branded online retail platform in The Netherlands and Europe.
The European Slim Winkel online store will sell psilocybin truffles as well as functional mushrooms in The Netherlands. The website will also service other parts of Europe, but without the access to psilocybin truffles. Management believes launching the online smart shop will enable the company to establish and build its brand while the brick-and-mortar strategy was put on hold until the end of the pandemic. The website was launched this morning with a domain name of slim-winkel.nl.
The online strategy will benefit Super Smart in four distinct ways. Firstly, it will help establish the Slim Winkel brand and Super Smart's evolved Smart Shop concept. Secondly, it will enable the company to continue to curate quality products, which will eventually include its own branded psilocybin truffles in The Netherlands. Thirdly, it will enable Super Smart to continue to develop its psilocybin supply chain. Lastly, by introducing the store in other European countries, it will enable Super Smart to capitalize on an already established distribution model and psilocybin supply chain when other European countries legalize. This last point also includes the U.S. Slim Winkel platform.
The introduction of a specialty online smart shop featuring a carefully curated selection of both psilocybin truffles and functional mushrooms with educational content is a first for the smart shop industry. The current product offering is an initial curated assortment that will continuously grow as the team sources new products that meet the company's stringent guidelines. Visitors to the Dutch Slim Winkel e-commerce site will be treated to informative blogs and educational tips that will allow them to easily integrate functional mushrooms and psilocybin micro dosing into their lifestyle. Super Smart believes these educational resources are the backbone of the Slim Winkel concept. The Company believes that by providing these additional services its customers will have a deeper understanding of the benefits of Super Smart's product offering.
"Our concept with Slim Winkel is to create a more modern retail experience in the space; one that blends information and education. We want to move away from a tourist centric approach to a lifestyle one. Our goal is to bring psychedelics out of the shadows and make micro dosing a normal part of everyday mental health" said Harry Resin, President of Super Smart. The brick-and-mortar strategy will resume once management is confident the lockdowns have subsided. As previously mentioned, the Company has located several premium locations in Amsterdam for the building of a major flagship store. The buildout of that store is a core focus and management will move immediately to sign a lease and commence the build out as soon as the country opens up on a seemingly permanent basis. Management also still intends to follow through on a build out or acquisition of stores in 5 other identified cities in The Netherlands.
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. The Company owns 80% of Pharmadrug Production GmbH, 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 EU. The Company also owns 100% of Super Smart, a Dutch company building a modern adult use psychedelic retail business with an elevated and educational focus. PharmaDrug recently acquired Sairiyo Therapeutics, a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through regulatory and research driven clinical trials.
For further information, please contact:
Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-1824
mgland
4年前
LMLLF news. PharmaDrug Announces First FDA Orphan Drug Designation of DMT for the Prevention of Ischemia-Reperfusion Injury from Organ Transplantation
8:03 am ET April 28, 2021 (Newsfile) Print
Toronto, Ontario--(Newsfile Corp. - April 28, 2021) - PharmaDrug Inc. (CSE: BUZZ) (OTC Pink: 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 the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") to dimethyltryptamine ("DMT") for prevention of ischemia-reperfusion injury ("IRI") in patients undergoing solid organ transplantation, which includes the liver, kidney, heart and lung, to the Company's wholly-owned subsidiary Sairiyo Therapeutics Inc. The FDA ODD granted is broader than the Company's original application for kidney transplantation, recognizing the pernicious consequences of IRI in all solid organ transplantation.
Before filing an Investigational New Drug ("IND") application with the FDA to evaluate DMT in human clinical trials, the Company will advance its overall DMT strategy on three separate initiatives. Firstly, PharmaDrug is already at work evaluating specific DMT formulations aimed at superior delivery and improved efficacy. Secondly, management will contemplate additional pre-clinical research in inflammatory and oxidative stress-induced complications, including organ transplants, to better understand the role DMT plays in the field. Lastly, the Company will broaden its scope to evaluate other rare indications that potentially could benefit from DMT.
"We are the first and only company in the world to receive FDA orphan drug designation for DMT," said Daniel Cohen, CEO of PharmaDrug. "We are incredibly pleased to have reached this significant milestone as it validates our strategy in discovering novel uses, formulations and delivery methods for DMT while also securing market exclusivity and patent protection of DMT for rare diseases. We are building on this achievement by positioning our research initiatives to evaluate DMT in potential human clinical studies for these types of serious and life-threatening indications."
Organ Transplants and DMT
According to the U.S. Organ Procurement and Transplantation Network, there are approximately 107,000 patients waiting for solid organ transplants in the United States, with the four most common organs transplanted being liver, kidney, heart, and lung (Accessed on April 27, 2021. Available online: https://optn.transplant.hrsa.gov/data/)
IRI in organ transplantation can result in a higher incidence of acute and chronic rejection, as well as long-term morbidity and mortality. Quickly restoring blood supply of ischemic organs as soon as possible is crucial for avoiding or reducing injury from ischemia, while strategies used to attenuate the damage induced by reperfusion, include ischemic preconditioning, ischemic postconditioning, and machine perfusion. These strategies are expensive, sometimes technically challenging, and only partially effective at preventing or treating acute organ dysfunction. With a shortage of quality organs and the need for expensive medical strategies, it is clear that novel approaches to improve graft function and patient outcome are desperately needed.
Research studies have shown that DMT activates the sigma-1 receptor ("Sig-1R"), an intracellular chaperone fulfilling an interface role between the endoplasmic reticulum ("ER") and mitochondria in cells. Sig-IR ensures the correct transmission of ER stress into the nucleus resulting in the enhanced production of anti-stress and antioxidant proteins. Consistent with these functions, DMT was found to mitigate ischemia-reperfusion injury (IRI) caused by hypoxia, oxidative stress and inflammation in preclinical models of renal transplantation.[1] The anti-inflammatory protective effects of DMT may provide a novel, more beneficial strategy to attenuate the damage induced by IRI during organ transplantation.
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). The FDA grants ODD status to products that treat and/or prevent rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify DMT for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.
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. The Company owns 80% of Pharmadrug Production GmbH, 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 EU. The Company also owns 100% of Super Smart, a Dutch company building a modern adult use psychedelic retail business with an elevated and educational focus. PharmaDrug recently acquired Sairiyo Therapeutics, a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through regulatory and research driven clinical trials.
For further information, please contact:
Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-1824
mgland
4年前
Psyched: California Psychedelics Bill Passes Second Committee, GH Research Closes $125M Series B, Study Shows Psilocybin Could Equal SSRI Results In Depression
https://www.yahoo.com/finance/news/psyched-california-psychedelics-bill-passes-215031414.html
Natan Ponieman
Mon, April 19, 2021, 2:50 PM
A bill that would remove penalties for the possession, personal use and social sharing of certain natural and synthetic psychedelics in California passed the state Senate Health Committee.
The bill will now be reviewed by the Senate Appropriations Committee, after which it would move to a Senate floor vote if approved.
SB 519 would decriminalize psilocybin, psilocyn, DMT, ibogaine, mescaline, LSD, ketamine and MDMA while expunging the criminal records of those convicted with low-level psychedelics charges.
“It'll still be illegal to sell it. And the bill does not legalize in a regulatory way,” state Sen. Scott Wiener, the bill’s main backer, told Benzinga.
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The legislation also “sets up a working group to evaluate whether to fully legalize and regulate psychedelics in the future, and the working group will make a recommendation to the legislature,” he said.
The working group could make recommendations for the creation of a licensed medical program focused on the use of psychedelics in a therapeutic setting, Wiener said.
The senator also commented on the bill’s chances of becoming law.
“This idea has never been introduced in the legislature before, so for many of my colleagues, this is the first time that they're seeing it. So there's a lot of education and a learning curve, and so we may not be able to pass it this year, but if not this year we'll keep trying. I think it’s an important issue and I’m committed to it,” said Wiener.
GH Research Closes $125M Series B For 5-Meo-DMT Research
The Dublin-based biotech company GH Research announced the closing of a Series B financing round for $125 million.
The company focuses on researching 5-MeO-DMT, a very potent psychedelic compound naturally produced by the Sonoran Desert frog. In November, the company completed a Phase 1 clinical trial using GH001, its main drug candidate, which is an inhalable version of 5-MeO-DMT.
The study showed the compound was well-tolerated in healthy subjects, which allowed the company to move to a Phase 1/2 clinical trial testing the product in patients with treatment-resistant depression.
GH Research said its goal is to develop a way of administering GH001 in single-day, individualized interventions, leading to a possible fast and durable remission of depression symptoms.
The company stated plans to continue research of GH001 into other psychiatric and neurological conditions, as well as researching GH002, an injectable version of 5-MeO-DMT that is in preclinical stages.
New Head-To-Head Trial Shows Psilocybin Could Be At Least As Effective As SSRIs In Depression Treatment
A study published Thursday in the New England Journal of Medicine did not find a significant difference in antidepressant effects between psilocybin and escitalopram, a commonly used antidepressant of the selective serotonin reuptake inhibitor class.
The trial was led by Robin Carhart-Harris, head of the Centre for Psychedelic Research at the Imperial College London.
The Phase 2, double-blind, randomized, controlled trial examined 59 participants with major depressive disorder who were divided into two groups.
A first group received a dose of 25 milligrams of psilocybin on two occasions with a space of three weeks, as well as a placebo for the SSRI during six weeks.
The other group received a very small (1-milligram) dose of psilocybin in two occasions and six weeks of real escitalopram.
All patients received psychological support.
The psilocybin used in the study was COMP360, Compass Pathways’ (NASDAQ: CMPS) proprietary crystalline psilocybin formulation.
Results were measured using a 16-item depressive symptomatology self-report questionnaire.
The mean scores for the psilocybin group were slightly more positive.
The paper stated that nonetheless, “larger and longer trials are required to compare psilocybin with established antidepressants.”
Maine Lawmakers Look Into All-Drug Decriminalization
State Rep. Anne Perry has introduced a bill in the Maine legislature that intends to decriminalize the possession of all illicit drugs in an effort to correct some of the harms caused by the war on drugs.
The measure would make low-level possession of scheduled substances a civil violation punishable with a $100 fine. The individuals charged would also be referred to a drug treatment program.
The measure is similar to a legislation that passed in November in Oregon by a ballot vote, by which simple possession of illegal drugs became a low-level offense in the Beaver State.
The bill will first head over to the Maine legislature’s Criminal Justice and Public Safety Committee for consideration.
The Milestone Round
Silo Wellness announced the inking of a binding letter of intent with Jungle Med Inc. for the commercialization of Silo’s patent-pending psilocybin nasal spray in Brazil and Colombia.
The letter proposes a five-year licensing contract with an upfront licensing fee of $250,000.
Red Light Holland Corp. (Pink: TRUFF) entered a non-binding letter of intent to purchase 80% of Happy Caps Farm, a Canadian mushroom farm that specializes in the sale of “grow your own” mushroom kits.
Cybin (OTCQB: CLXPF) announced plans to commence preclinical work on two novel tryptamine formulations: CYB003, an orally dissolving tablet, and CYB004, an inhaled version of the same compound.
See more from Benzinga
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California Bill To Decriminalize Psychedelics Moves Forward: Legislation's Sponsor Talks 'Learning Curve,' Why MDMA, LSD Are Included
Adult-Use Cannabis Is Now Legal In New Mexico: Gov. Signs Legalization, Expungement Bills
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oatsuzn
4年前
PharmaDrug Provides Update on Its Annual General Meeting
Toronto, Ontario--(Newsfile Corp. - March 12, 2021) - PharmaDrug Inc. (CSE: BUZZ) (OTC Pink:LMLLF) ("PharmaDrug" or the "Company"), will hold its Annual General Meeting ("AGM" or "Meeting") on March 25, 2021 at 10:00AM Eastern Standard Time at its corporate office, Suite 2905 - 77 King Street West, Toronto. The call-in number for the Meeting is 1-855-473-1059 and the access #0091269.
In light of the ongoing COVID-19 situation, the Company strongly encourages registered shareholders and proxyholders not to attend the AGM in person, and Shareholders are encouraged to vote using one of the methods described in the Management Information Circular ("MIC") which can be viewed on SEDAR. The Meeting can be accessed by conference call. This call will be listen-only and shareholders will not be able to vote or speak at, or otherwise participate in the Meeting via the conference call. The Corporation's board of directors and auditors do not plan to attend the Meeting in person.
mgland
4年前
PharmaDrug Announces Drug-Repurposing Expert Moshe Rogosnitzky Joins Sairiyo Therapeutics Scientific and Clinical Advisory Board
8:02 am ET March 9, 2021 (Newsfile) Print
Toronto, Ontario--(Newsfile Corp. - March 9, 2021) - PharmaDrug Inc. (CSE: BUZZ) (OTC Pink: LMLLF) ("PharmaDrug" or the "Company") wholly-owned subsidiary, Sairiyo Therapeutics Inc. ("Sairiyo"), a biotechnology company focused on the research and development of Cepharanthine, a repurposed and reformulated naturally-derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases, is pleased to announce that world-renowned drug-repurposing expert, Moshe Rogosnitzky, has been appointed to Sairiyo's newly-formed scientific and clinical advisory board for Cepharanthine as a potential treatment for cancer, neurological, inflammatory and infectious diseases.
Moshe Rogosnitzky, heads Drug Rediscovery Group Ltd in Rehovot, Israel, focusing on the repurposing of generic drugs for diseases such as ophthalmic disorders, viral infections, insomnia, pain disorders, and opioid addiction. He also serves as executive director of the MedInsight Institute, a US/Israel non-profit organization that educates physicians and patients about treatment opportunities using generic drugs in an off-label fashion. A pioneer in the generic drug-repurposing field, and in personalized cancer therapy, Mr. Rogosnitzky has more than 15 years of experience in the use of Cepharanthine for treating advanced cancers, as well as androgenic alopecia, or male-pattern baldness. In 2011, he published a comprehensive review on the potential of Cepharanthine for a range of clinical conditions. Most recently he has published a review of Cepharanthine's potential in treating COVID-19.
"I am passionate about repurposing safe and well-established drugs for treating cancer, whether alone or as adjuvants to existing therapies. Cepharanthine presents a unique opportunity to repurpose an extremely safe drug that has been approved and used in Japan for other clinical indications for many years," said Mr. Rogosnitzky. "It is my hope that this plant-derived drug, possessing an enviable safety record, will provide fresh hope to patients suffering from incurable cancers and other serious and life-threatening diseases."
"We are grateful to have Moshe Rogosnitzky join us as an advisor to support our development plans with Cepharanthine which has tremendous potential in not only cancer but also in other serious and rare diseases," said Daniel Cohen, CEO of PharmaDrug. "Moshe Rogosnitzky has an in-depth knowledge and appreciation for Cepharanthine's potential and him joining our scientific and clinical advisory board dedicated to unlocking Cepharanthine's clinical utility for cancers and other indications brings value to our objective in developing a unique franchise with Cepharanthine."
Sairiyo received U.S. Food and Drug Administration ("FDA") orphan drug designation approval for Cepharanthine in the treatment of esophageal cancer.
Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to treat a variety of acute and chronic diseases. In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties1. Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials.
The Company's pharmaceutical strategy with Cepharanthine will focus on expanding its potential in cancer through pre-clinical and clinical research, forming research collaborations with academic institutions and industry and adding medical and clinical experts to its scientific and clinical advisory board.
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. The Company owns 80% of Pharmadrug Production GmbH, 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 EU. The Company also owns 100% of Super Smart, a Dutch company building a modern adult use psychedelic retail business with an elevated and educational focus. PharmaDrug recently acquired Sairiyo Therapeutics, a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through regulatory and research driven clinical trials.
For further information, please contact:
Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-1824
swim
4年前
PharmaDrug Files For FDA Orphan Drug Designation For DMT In Kidney Transplantation and Expands on Its Psychedelics Strategy 2021-02-25 07:34 ET - News Release
Toronto, Ontario--(Newsfile Corp. - February 25, 2021) - PharmaDrug Inc. (CSE: BUZZ) (OTC Pink: 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 it has expanded its psychedelic pharmaceutical program with the filing of an application with the U.S. Food and Drug Administration ("FDA") to receive Orphan Drug Designation ("ODD") for N,N-Dimethyltryptamine ("DMT") in the prevention of ischemia reperfusion injury in patients undergoing kidney transplantation.
Pharmaceutical Psychedelics Strategy
Following the acquisition of Sairiyo Therapeutics and its biotech R&D core competencies, PharmaDrug has undertaken efforts to expand its research activities in the pharmaceutical psychedelics space. The Company's psychedelic pharmaceutical strategy will focus specifically on DMT. Through engagement with respected academics and medical/clinical KOLs in the space, management will initiate pivotal preclinical and clinical development activities. Taking advantage of existing expertise and relationships, PharmaDrug will seek to broaden its intellectual property portfolio by creating unique DMT formulations. Further differentiation in the space will be derived from the work that PharmaDrug will initiate around novel uses for DMT; the ultimate goal of which is to fuse outstanding science and clinical translation.
"We have been focused on laying the foundation in becoming an industry leader in the research and development of novel uses for DMT in the treatment of neuropsychiatric, neurological and inflammatory disorders," said Daniel Cohen, CEO of PharmaDrug. "Although DMT is commonly associated with offering an intense psychedelic experience, the therapeutic potential of DMT is fascinating and remains underexplored. We aim to unlock the potential of DMT in treating unmet medical needs beyond its potential utility in mental health disorders. Our orphan drug designation application for DMT in the prevention of kidney injury during transplant surgery fits with our psychedelic pharmaceutical strategy of creating a unique portfolio of DMT therapies targeting rare disorders while also focusing on foundational research with DMT to explore and evaluate its therapeutic potential both in the brain and other human organs."
Kidney Transplants and DMT
The population of patients needing renal replacement therapy worldwide is estimated to be 5 million. There is a significant worldwide shortage of suitable kidney donors for transplantation. The number of kidney transplantations performed worldwide in 2018 was 75.664 [1].
In the U.S., the Human Resources and Services Administration and the Department of Health and Human Services Organ Procurement and Transplantation Network estimated that there are approximately 109,000 individuals currently on the national transplant waiting list and approximately 92,000 of these are waiting for a kidney transplant. In 2020, the number of patients receiving a kidney transplant was 22,871 down 2.5% from 2019 when there were 23,401 kidney transplants.
Ischemia/reperfusion injury (IRI) is caused by a sudden temporary impairment of the blood flow to a particular organ. IRI is associated with a robust inflammatory and oxidative stress response to hypoxia and reperfusion which disturbs the organ function. Quickly restoring blood supply of ischemic kidney remains the cornerstone for avoiding or reducing injury from ischemia. Additional strategies used to attenuate the damage induced by reperfusion include ischemic preconditioning, ischemic postconditioning, and machine perfusion. These strategies are expensive, sometimes difficult to perform in clinical settings, and provide only limited benefit. As such, novel approaches that prevent transplant associated renal IRI are sorely needed.
Research studies have shown that DMT activates the sigma-1 receptor ("Sig-1R"), an intracellular chaperone fulfilling an interface role between the endoplasmic reticulum ("ER") and mitochondria in cells. Sig-IR ensures the correct transmission of ER stress into the nucleus resulting in the enhanced production of anti-stress and antioxidant proteins. DMT has also been shown to have anti-inflammatory properties. Consistent with these functions, DMT was found to mitigate ischemia-reperfusion injury (IRI) caused by hypoxia, oxidative stress and inflammation in preclinical models of renal transplantation.[2] The anti-inflammatory protective effects of DMT may provide a novel, more beneficial strategy to attenuate the damage induced by ischemia and reperfusion during kidney transplantation.
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify DMT for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.
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. The Company owns 80% of Pharmadrug Production GmbH, 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 EU. The Company also owns 100% of Super Smart, a Dutch company building a modern adult use psychedelic retail business with an elevated and educational focus. PharmaDrug recently acquired Sairiyo Therapeutics, a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through regulatory and research driven clinical trials.
For further information, please contact:
Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-1824
oatsuzn
4年前
From Marijuana To Magic Mushrooms: Harry Resin Has 'Cutting Edge' Psychedelic Plans
https://www.benzinga.com/markets/cannabis/20/05/16131724/from-marijuana-to-magic-mushrooms-harry-resin-has-cutting-edge-psychedelic-plans
For Harry Resin, working in the cannabis industry has been quite a trip.
After spending some two decades growing, breeding and writing about pot, the 44-year-old entrepreneur now has his sights set on another niche industry — psychedelics.
Resin, an early inductee into the High Times Seed Bank Hall of Fame, recently inked a deal between his startup — Super Smart — and Pharmadrug Inc., a medicinal research company based in Toronto.
Terms of the deal were not disclosed, but Resin revealed to Benzinga tons of background info on the transaction and the combined company's strategy going forward.
"The approach we are trying to take is to eliminate the stigma associated with magic mushrooms," Resin told me. "By having one-on-one consultations with our customers, we will be able to educate them and offer them a more informed experience."
Below, Oakland-based Resin chats about the "party drug" stigma surrounding psychedelics, his plan to bring "cutting edge" products to market, and why "microdosing" with mushrooms will eventually become mainstream.
BZ: How did the merger with Pharmadrug come about?
HR: I’ve been active in the cannabis sector for a long time and was approached by some investors in Canada to spearhead this new project. They came to me for my years of experience working in Amsterdam.
With my experience as a supply chain coordinator for many of the Dutch coffeeshops, I have a unique understanding of working in a deeply regulated sector like the Dutch smart shop industry. Many of my contacts are involved in that industry so it was a natural fit. This is what led me to the team and putting the SuperSmarty deal together. By luck, an old friend of mine's husband was the CEO of Pharmadrug and we got to talking. One thing led to another and we had a deal.
What made it a great fit?
It’s a great fit because with Pharmadrug’s license, we will have a two-pronged approach: The smart shops in the Netherlands will allow us to build a recreational model selling magic mushrooms, while Pharmadrug will allow us to import alternative plant-based medicine to pharmacies throughout Europe.
Do you still write, or did you transition completely to being CEO of Super Smart?
I still write and I’m still active in cannabis. I pride myself on being at the forefront of industries making the leap from the counter culture to the mainstream. So for me there was a natural evolution with cannabis and psilocybin.
Additionally, the work we are currently doing in cannabis with extraction technology and water solubility will drive product development and brand building in the psilocybin space. By having a retail presence in a legal market like the Netherlands, we will be on the forefront of releasing new products in the space. We are going to work with a strong advisory board in order to also help develop new products in the space. All of which we can test in the legal market in the Netherlands.
Like cannabis, there's a stigma attached to psychedelics – at least in the U.S. What should skeptics know?
As with cannabis we need to look beyond the stigma and beyond the false information circulated during the global “war on drugs.” Psilocybin is currently going through a renaissance because more and more people are realizing it can be used medicinally rather than solely as a party drug. There are currently many studies being undertaken looking at the mental health benefits of microdosing and its become something very popular in the world of nootropics.
2020 has been a troublesome year for small business owners. What trends do you expect to see for the remainder of the year, and heading into 2021?
I see a combination of consolidation and more curated retail experiences. By interacting more intimately with customers and limiting the amount of customers coming into stores at one time, it will fulfill both the role of social distancing and of a more curated experience. The approach we are trying to take is to eliminate the stigma associated with magic mushrooms and by having one-on-one consultations with our customers, we will be able to educate them and offer them a more informed experience.
What about the industry surprises you?
I'd say the scientific advances are what probably surprised me the most. To go from smoking hand-rubbed hash and cannabis flower to dabbing THCA diamond crystals bathed in terpene juice is something else. That's what excited me the most about psychedelics. It becomes the 'what next.'
With our connections and my cannabis experience, we plan on being on the cutting edge of new products in the psychedelic space. Dosing eventually will be a crucial aspect of using the plant as medicine with replicable results. Therefore extracting psilocybin and developing new novel methodologies with which to use that extraction excite us and will be an important part of the future.
Any advancements so far?
Truthfully I was able to make rudimentary ethanol extraction that was dabbable and the effect was interesting. Stronger than a cannabis oil dab, but not quite hallucinogenic. This idea of microdosing and curating experience will be an interesting concept to play within the space. By having the strong retail arm in the Netherlands, we will have a vast sea with which to explore all the possibilities of new products and their interactions with our customers. We will also track our customers' effects through questionnaires so that we can collect as much data as possible in an empirical way when it comes to product efficacy. This will also help us shape the future of the psychedelic industry and what will collectively come up with as the next advancement. To me that's really exciting.
What lessons did you learn over the years?
The lesson I’ve learned is that acceptance is possible. I never thought that the counter culture would reach the mainstream. It's great to see these plants and fungi that have been evolving alongside humanity — finally get the respect they deserve.
oatsuzn
4年前
PharmaDrug Files for FDA Orphan Drug Designation for DMT in Stroke
https://www.newsfilecorp.com/release/74241/PharmaDrug-Files-for-FDA-Orphan-Drug-Designation-for-DMT-in-Stroke
Toronto, Ontario--(Newsfile Corp. - February 11, 2021) - PharmaDrug Inc. (CSE: BUZZ) (OTC: LMLLF) ("PharmaDrug" or the "Company"), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances, natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce it has filed an application with the U.S. Food and Drug Administration ("FDA") to receive Orphan Drug Designation ("ODD") for N,N-Dimethyltryptamine ("DMT") in the treatment of acute ischemic stroke patients presenting for emergency medical assistance within 3-hours of symptom onset.
Acute ischemic stroke is characterized by the sudden loss of blood circulation to an area of the brain, resulting in a corresponding loss of neurologic function. Around 85% of all strokes are due to a blockage cutting off the blood supply to the brain. Stroke-related costs in the United States were approximately $46 billion between 2014 and 2015. (Source: CDC).
In pre-clinical research, DMT has been shown to improve ischemic brain injury in rats, both by decreasing brain lesion volume and by improving subsequent motor function recovery. Following acute ischemic stroke DMT activates the sigma-1 receptor (Sig-1R) and critical downstream pathways known to enhance production of anti-stress and antioxidant proteins; the impact of which, specifically diminishes the deleterious impact of hypoxia and oxidative stress to brain cells. Restoration of blood flow to affected regions of the brain through administration of tissue plasminogen activator (tPA aka alteplase), long considered gold-standard treatment for ischemic stroke, often only partially rescues damaged brain regions. As such, the development of novel approaches to treat ischemic stroke, such as PharmaDrug's DMT program, represent a critical development in reducing patients resulting neurological deficit.
"We are building an industry-leading foundation to explore the clinical potential of DMT in rare neuropsychiatric and neurological disorders. With the submission of our orphan drug application to the FDA now complete we will move swiftly to accelerate the research and development of DMT for acute ischemic stroke," said Daniel Cohen, CEO of PharmaDrug. "Additionally, we will continue to broaden our DMT clinical programs by taking advantage of valuable FDA regulatory incentives such as orphan drug, fast track and breakthrough therapy designations."
The Company's psychedelic pharmaceutical strategy will focus on DMT by expanding its product pipeline through licensing, pre-clinical and clinical research, forming research collaborations with academic institutions and industry, broadening its intellectual property portfolio with unique formulations, development of novel uses and delivery systems, and by adding medical and clinical experts to its scientific advisory board.
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify DMT for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.
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