• PharmAla Biotech (CSE:MDMA) will start an observational trial on patients treated with 3,4 Methylenedioxymethamphetamine (MDMA)
  • The Vancouver-based biotechnology company has completed a letter of intent and received initial Ethics Board approval to begin the trial with the University of Calgary and Heroic Hearts Canada
  • PharmAla Biotech is the only manufacturer of GMP MDMA for clinical use in Canada
  • PharmAla Biotech Holdings Inc. last traded at $0.11 per share

PharmAla Biotech (CSE:MDMA) will start an observational trial on patients treated with 3,4 Methylenedioxymethamphetamine (MDMA).

The Vancouver-based biotechnology company has completed a letter of intent and received initial Ethics Board approval to begin the trial with the University of Calgary and Heroic Hearts Canada, a charity supporting veteran mental health by facilitating access to psychedelic-assisted therapy.

“While clinical evidence in the form of trial data on the efficacy of MDMA as a treatment for PTSD has been published – and is encouraging – this is a global first: an assessment of the efficacy of MDMA in treating PTSD outside the bounds of a clinical trial,” Dr. Leah Mayo, Parker Psychedelics Research chair, University of Calgary, said in a statement

PharmAla Biotech is the only manufacturer of GMP MDMA for clinical use in Canada.

PharmAla will provide drug product to physicians under the Special Access Programme (SAP) through its licensed distribution partners, and connect clinicians and patients with University of Calgary researchers for voluntary data collection.

The University of Calgary, under the direction of Mayo, will assess data pertaining to efficacy of MDMA in the treatment of Post-Traumatic Stress Disorder (PTSD) under real-world circumstances. The university will have full rights to publication of data generated by the trial.

The announcement comes after the release of the Senate of Canada’s Subcommittee on Veterans report earlier this week, titled The Time is Now: Granting equitable access to psychedelic-assisted therapies. The report urged Veterans Affairs Canada to increase research into the treatment of veterans’ “moral injuries” such as PTSD with psychedelic molecules, including MDMA. 

“Our ability to treat patients through SAP, while imperfect, remains a credit to Canadian regulators and an incredibly valuable tool for the collection of evidence of MDMA’s efficacy in real-world clinical outcomes. We’re incredibly pleased to work with Dr. Mayo and Heroic Hearts to bring together patients, clinicians, and scientists,” Nick Kadysh, CEO of PharmAla Biotech, said in a statement. “We are already seeing amazing results in patients, and we believe we are currently the only company in the world that can generate evidence from SAP which can be shared directly with regulators, as well as the scientific community.”

PharmAla Biotech is focused on researching, developing, and manufacturing MDXX class molecules including MDMA.

PharmAla Biotech Holdings Inc. last traded at $0.11 per share and its stock is up 266.6 per cent over the past year.

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