Toronto, ON – January 20th, 2024 - PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it has executed an agreement with Merhavim Mental Health Centre of Beer Yaakov, Israel (“Merhavim”). All data generated in the clinical trial, entitled “MDMA Assisted Psychotherapy for PTSD of Early Sexual Trauma Compared to All Trauma in Adulthood”, will be licensed to PharmAla for regulatory and commercial purposes in exchange for the clinical trial material, which will be provided by PharmAla on a zero- cost basis. MAPS Israel, an Israeli non-profit organization whose mission is to develop psychedelic research and educational programs based in public health, is also a partner to the clinical trial.
“The recent announcement of a cease-fire in the Gaza conflict means that now is the time to work towards healing. We look forward to supporting Merhavim in their clinical trial, which we believe will help patients in Israel, and ultimately worldwide,” said Nicholas Kadysh, CEO, PharmAla Biotech. “There is now an incredibly deep and broad set of clinical data proving MDMA’s efficacy in the treatment of Post-Traumatic Stress Disorder, and PharmAla works day-in and day-out to expand that data with our customers and research partners. However, to the best of our knowledge, this will be the first trial to explicitly examine MDMA’s efficacy in the treatment of recent versus aged trauma.”
PharmAla will seek to ship its LaNeo MDMA Clinical Research Materials to Merhavim at the first opportunity, subject to customary regulatory approvals. PharmAla looks forward to additional opportunities to collaborate with MAPS Israel on other research projects.
Researchers can access a tool, offered at https://pharmala.ca/clinical-trials, which provides access to drug product quality information, which researchers can examine directly. PharmAla is confident that it can offer research customers rapid support to convert their clinical trial registrations and IRB approvals to the LaNeo MDMA Chemistry, Manufacturing and Control package.
PharmAla will consider discounts in favour of data sharing where appropriate. Qualified researchers may contact sales@pharmala.ca.
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.
Nicholas Kadysh, CEO
press@pharmala.ca