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PharmAla Biotech appoints Kevin Roy to its Board of Directors

PharmAla Biotech appoints Kevin Roy to its Board of Directors

Mr. Roy will bring exceptional financial expertise to PharmAla’s Board and improve the company’s corporate governance

VANCOUVER, BC, July 4, 2022 /CNW/ – PharmAla Biotech Holdings Inc. (CNSX: MDMA) is pleased to announce that it has appointed Mr. Kevin Roy to its board of directors. An exceptionally qualified former CFO, Mr. Roy will lend his financial expertise to the company.

“I’m so pleased to welcome Kevin to the PharmAla Board. He brings exactly the kind of experience we need to our team,” said Jodi Butts, PharmAla’s Board Chair. “His strong accountancy and fiduciary experience will increase the company’s corporate governance and allow us to continue growing the business of supporting clinical trial practitioners globally.”

Mr. Roy is a former executive team member at FirstService Corporation (FSV: TSX, NASDAQ), having served as CFO of FirstService Brands division, and is a Chartered Professional Accountant. He lives in Toronto with his family. Mr. Roy will serve as chair of the Company’s Audit Committee.

“I’m excited to join PharmAla’s board and contribute to the company’s growth,” said Kevin Roy. “The company’s development over the past year has been impressive, and I am fully committed to the company’s mission of developing MDMA as a treatment for a number of mental health conditions.”

PharmAla Biotech also announces, with gratitude and regret, the resignation of former Director Solomon Elimimian.
For more information, please visit www.PharmAla.ca, where you can sign up to receive regular news updates.

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

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PharmAla Biotech Registers Trademark for MDMA

PharmAla Biotech Registers Trademark for MDMA

The Company’s clinical-grade GMP MDMA product is now known as “Laneo”

VANCOUVER, June 24, 2022 (Canada Newswire) – PharmAla Biotech (CSE:MDMA) has registered a trademark for its clinical-grade MDMA product, which shall be marketed as Laneo MDMA. PharmAla is currently the only publicly-traded company to have developed a full manufacturing value chain for MDMA.

“While MDMA is a generic drug, there’s a huge difference between illicit drug manufacture and our clinical-grade product. Only one is appropriate for use in scientific research: Laneo MDMA,“ said Nick Kadysh, CEO of PharmAla Biotech. “With this trademark registration, PharmAla continues to establish itself as the leader in MDMA manufacture, research, and development.”

A number of customers have already made deposits for Laneo MDMA, and the company anticipates initial product deliveries to be made in Fall of 2022. Laneo MDMA is initially available to customers in both a 40mg formulated clinical trial capsule and as pure Active Pharmaceutical Ingredient (API) which can be compounded by a qualified pharmacist. In the future, a range of drug product formulations can be developed.

“We’re speaking to customers every day who are excited to initiate clinical trials with MDMA – but they are unable to do so because up until now, they didn’t have access to clinical trial supply of drug product,” said David Purcell, Director of Sales at PharmAla Biotech. “PharmAla Biotech’s Laneo MDMA is the answer.”

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

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PharmAla Biotech Supports Decision to Decriminalize Possession of MDMA in British Columbia

PharmAla Biotech Supports Decision to Decriminalize Possession of MDMA in British Columbia

The Decision, taken by Health Canada, to decriminalize possession of MDMA under 2.5g, comes pursuant to a request from the Government of British Columbia

VANCOUVER, BC, June 2, 2022 /CNW/ – PharmAla Biotech (CSE: MDMA) strongly endorses the decision by the Government of Canada to decriminalize possession of 2.5g or less of MDMA in the province of British Columbia.

“This decision is critically important. As a company focused on the manufacturing of legal MDMA for clinical research, we strongly believe that MDMA is safe for human use, and of medical benefit if taken as part of a treatment regimen,” said Jodi Butts, Board Chair of PharmAla Biotech. “While more work needs to be done, we are happy to see the Government of Canada take this historic action in British Columbia.”

PharmAla Biotech is the only manufacturer of MDMA for clinical use in North America. It does not engage with, nor will it benefit in any way, from the decision taken by the Governments of British Columbia and Canada over the possession of illicit MDMA.

“MDMA does not fit the profile of a Schedule I narcotic. It is, generally speaking, well-tolerated. However, the threat of illegal supply and toxic contaminants is a serious public health risk,” said Nick Kadysh, PharmAla’s CEO. “PharmAla developed the only MDMA manufacturing value chain in North America in order to provide clinical researchers with the supplies they need to complete valuable scientific research – and our own research into novel MDMA analogs will heighten the safety profile of this molecule, so it can be used as a medicine.”

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

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World’s first psychedelic trade association

Psychedelics Canada Announces The Launch Of The First National Trade Association For Legal Psychedelics Companies

Cybin (CYBN), PharmAla Biotech (MDMA), PharmaTher (PHRM), and 9 other companies joined forces to create Psychedelics Canada – the first ever national trade association for legal psychedelics companies.

The association will speak on behalf of the psychedelics industry to government, the press, and the public to advance psychedelic research and policy change.

PDF of article

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PharmAla Biotech & SABI Mind Announce MDMA Supply Agreement

PharmAla Biotech & SABI Mind Announce MDMA Supply Agreement

PharmAla to supply SABI Mind’s Healing Centres, subject to Health Canada approval

VANCOUVER, May 19, 2022 (Canada Newswire) – PharmAla Biotech (CSE:MDMA) is pleased to announce that it has signed an agreement with SABI Mind Inc. which will allow for its GMP MDMA to be administered to patients at SABI Mind’s Healing Centres. SABI Mind is a leading and rapidly growing psychedelic clinic and research organization that provides psychedelic-assisted therapies in Calgary and at upcoming locations in Edmonton and Victoria.

“We’re very pleased to announce this supply agreement with PharmAla to increase access to psychedelic-assisted therapies for patients in need”, says Philippe Lucas PhD, President at SABI Mind. “Research has shown MDMA to be a safe and effective treatment for PTSD, end of life anxiety, and other treatment-resistant mental health issues, and our clinical team is looking forward to working with patients, Health Canada and the highly qualified team at PharmAla to provide MDMA-based treatments to authorized patients.”

Through this agreement, PharmAla will provide GMP, clinical-grade MDMA to SABI Mind, subject to regulatory approval. The MDMA will come from PharmAla’s GMP MDMA value chain, the first to be established in North America. As part of the agreement, PharmAla will have a right to access anonymized patient data collected during treatment by SABI Mind.

“I have long respected SABI and their principals for operating at high ethical and regulatory standards. Their work on developing the Canadian Psychedelic Survey prove that they are true academic leaders in the psychedelics industry,” said Nick Kadysh, PharmAla’s CEO. “As such, I think this is a natural partnership for both of our companies, and should allow for SABI Mind to expand their current offerings of psychedelic-assisted therapies.”

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

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PharmAla Biotech to supply Mind Medicine Australia with GMP MDMA for Clinical Trial

PharmAla Biotech to supply Mind Medicine Australia with GMP MDMA for Clinical Trial

PharmAla’s GMP MDMA will accelerate trial work funded by Australia’s premier Psychedelics charity

VANCOUVER, BC, April 8, 2022 /CNW/ – PharmAla Biotech is proud to have been selected as the MDMA manufacturing partner for Mind Medicine Australia. Mind Medicine Australia’s order will be available for delivery later this year, for use in an ethics approved healthy persons trial and will be subject to all necessary government approvals being obtained.

“We’d like to congratulate Nick and his team for the ground-breaking work that they have done in developing GMP, medical grade MDMA for use in clinical trials and regulatory approved expanded access schemes,” said Peter Hunt, Board Chair of Mind Medicine Australia. “There is a desperate need for innovation in the mental health sector for hard-to-treat illnesses such as post-traumatic stress disorder which cause enormous suffering. Clinical trials have shown that MDMA assisted therapy is safe to use in clinically controlled environments and can achieve high remission rates for people suffering from post-traumatic stress disorder”.

Mind Medicine Australia is a registered charity founded by Tania de Jong AM and Peter Hunt AM in 2019. Mind Medicine Australia supports clinical research and is working towards regulatory-approved and evidence-based psychedelic-assisted therapies being available through the medical system in Australia for patients suffering from relevant treatment resistant mental illnesses including depression and post-traumatic stress disorder. Mind Medicine Australia connects medical practitioners, consumers, academia, government, industry, regulatory bodies, philanthropists, investors and other stakeholders and provides therapist training and clinical support for psychedelic assisted therapies through its Mind Medicine Institute. Mind Medicine Australia is focused specifically on the clinical application of regulatory approved medicinal psilocybin and medicinal MDMA assisted therapies for certain mental illnesses; its focus is entirely clinical in nature.

“PharmAla is currently the only company in North America which has completed a full GMP value chain for MDMA. We’re so excited to be able to advance the work of Mind Medicine Australia, an organization which I have long admired for both their scientific rigour and advocacy efforts,” said Nick Kadysh, PharmAla’s CEO. “I know that these research materials will be put to good use, healing people and generating the data which Mind Medicine will use in their continuing efforts to legalize and destigmatize MDMA and other psychedelic-based treatments.”

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

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PharmAla Biotech adds David Purcell as Director of Sales

PharmAla Biotech adds David Purcell as Director of Sales

Purcell to Accelerate PharmAla’s GMP MDMA Manufacturing and Sales Business

VANCOUVER, BC, March 14, 2022 /CNW/ – In order to better serve its clinical trial customers, PharmAla Biotech Holdings Inc. (CSE: MDMA) is pleased to announce the hiring of Mr. David Purcell as Director of Sales. As a seasoned executive with exceptional business development and clinical trial expertise, Mr. Purcell will be bringing the experience and knowledge garnered over two decades of business and product development in both the private and public sectors to PharmAla. The decision to add David Purcell to the team aligns with the company’s continuous expansion to ensure better service delivery to clients.

“PharmAla is currently the only company in North America which has completed a full GMP value chain for MDMA. We’re proud to be supplying scientific researchers globally,” said Nick Kadysh, PharmAla’s CEO. “David will be 100% focused on our customers. In his role as Director of Sales, David will not only grow our customer base, but develop enduring partnerships with institutions, clinical researchers, and our customers from the private sector.”

Prior to joining the team, David was the Chief Commercial Officer of Shelter Cannabis, where he oversaw the Business Development, Sales, Marketing, and Client Care teams, and directed the successful expansion of select cannabis products to new markets throughout Canada. He also led the expansion of the Cannabis Career Training program at Kwantlen Polytechnic University by developing new programs, facilitating the expansion of lab, extraction and testing facilities, and built partnerships with key Canadian and international institutions and industry partners, which built a scalable network of educators for National and International markets.

“I’m excited to join PharmAla at this critical moment in its development,” added David Purcell, incoming Director of Sales. “Supplying clinical-grade MDMA to trials globally is not just about the company’s bottom line – it’s also about ensuring that critical medical research gets done. I’m excited to contributed to that goal.”

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular news updates.

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

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PharmAla Biotech contracts with InterVivo Solutions to validate novel MDMA analogs

PharmAla Biotech contracts with InterVivo Solutions to validate novel MDMA analogs

Proof-of-concept preclinical animal research begun on PharmAla’s patented ABA series of non-scheduled MDXX compounds

VANCOUVER, March 3, 2022 (Canada Newswire) – PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA), a biotech company focused on the research, development and manufacturing of pharmaceuticals in the MDXX class, is pleased to announce that the Company has initiated preclinical research on a new class of patented novel chemical entities (NCEs) at InterVivo Solutions.

“PharmAla’s goal is to create novel drugs with improved toxicology profiles, and to expand use cases and indications for these drugs. PharmAla’s ABA series of drug candidates are based on a molecule in the MDXX class which is not scheduled as a controlled substance in Canada,” said Nick Kadysh, PharmAla’s CEO. “In InterVivo Solutions, we have found an excellent research partner to fast-track the research to select the most promising drug in the ABA series, and bring it forward to the Clinical phase.”

InterVivo Solutions is a well-established pre-clinical contract research organization (CRO) with expertise in neuropsychiatric and neurological diseases. Together with Transpharmation, they form the largest boutique Neuroscience -specialized small and large animal CRO. InterVivo Solutions will study PharmAla’s novel NCEs evaluating the molecules’ pharmacological effects and toxicology as compared to traditional, generic MDMA.

“InterVivo Solutions is proud to support the research efforts of PharmAla to develop novel entactogenic chemical entities with improved safety profiles. This safety-first approach will provide key insights that will not only de-risk their transition to clinical use, but also enhances our knowledge base and understanding of the key features of this disruptive class of molecules,” added Mark Duxon, CEO of InterVivo Solutions.

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular news updates.

About InterVivo Solutions/Transpharmation

Recently merged, InterVivo Solutions (IVS)/Transpharmation(TPH) is the world’s leading neuroscience contract research organization, offering translational research services with a focus on next-generation neuroscience drug discovery. IVS/TPH offers in vivo gold-standard pharmacological models, drug metabolism, pharmacokinetics and early safety research studies for a global network of biopharmaceutical clients.

www.intervivo.com

www.traspharmation.co.uk

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Global Wellness Strategies Signs MDMA Supply Agreement with PharmAla Biotech

Global Wellness Strategies Signs MDMA Supply Agreement with PharmAla Biotech

The Shanti Therapeutics Focus on Chronic Pain Market with Psychedelics

Vancouver, British Columbia–(Newsfile Corp. – February 10, 2022) – Global Wellness Strategies Inc. (CSE: GWS) (FSE: O3X4) (OTCQB: GWSFF) (“Global” or the “Company”) and their Contract Research Organization (“CRO”) iNGENü (a fully owned subsidiary of Cannvalate Pty Ltd) sign supply agreement with Canada-based PharmAla Biotech (CSE: MDMA) to supply GMP MDMA for the Shanti Therapeutics upcoming clinical trial.

Global Wellness’ Shanti Therapeutics is a first-in-class biotech utilizing the neuromodulation properties of MDMA (aka Ecstasy) to pre-emptively treat preoperative pain. Shanti has commenced a path to their clinical trial in 22 healthy volunteers comparing the pain tolerance threshold in patients who have had exposure to a proprietary dose and formulation of MDMA. This proof-of-concept clinical study is to gauge the effect size of an increase in the pain threshold in subjects who have been pre-emptively treated with MDMA. iNGENü was chosen as the Contract Research Organization (CRO), as they are a niche CRO specialized in novel psychedelic clinical trials.

“Biotechs face many roadblocks as a drug development journey begins. Choosing the right CRO can make or break a molecule’s future and a bad selection can derail the most aggressive clinical trial. Developing an integrated, big-picture roadmap for a molecule and company can only work with a formidable CRO, as even a lucrative discovery is a challenging and expensive endeavor. Not only do we have both a strong CRO to guide the research and trials plus the recently formed alliance with PharmAla, but also another Canadian partner Pharmascience Inc. completes their MDMA orders, which is Canada’s second largest manufacturer of generic and branded drugs and a tremendous milestone check mark for Shanti! These strategic partnerships are pivotal to the success of Shanti as the sponsor of the project and the discovery of a new molecule to solve the puzzle of chronic pain,” said Meris Kott, CEO, Global Wellness Strategies Inc.

“I’m thrilled that, as the first company to develop a full GMP MDMA value chain in North America, we can now help enable other companies such as Global Wellness Strategies,” said Nick Kadysh, founding CEO, PharmAla Biotech. “Alleviating the backlog of clinical-grade MDMA for research will accelerate the entire Psychedelics category, and help bring MDMA in the mainstream. Over the coming months we will be working diligently to fulfill Global Wellness Strategies’ needs, and support them as they move their research forward.”

ABOUT GLOBAL WELLNESS STRATEGIES

Global Wellness Strategies is a prospect generator that provides high growth companies with financial, operational, and management assistance in the fast-growing market for wellness consumer products. The focus of the Company is on global wellness, psychedelics, mycology, hemp and CBD, healthcare-related target companies.

For further information visit websites:
www.globalwellnessstrategies.com and www.shantitherapeutics.com

Or Contact Meris Kott CEO 604.484.0355 or email to info@globalwellnessstrategies.com

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.