Toronto, ON – August 7th, 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 completed customs clearance and delivery of over 500 capsules of the company’s LaNeo 40mg MDMA to Merhavim Mental Health Centre of Beer Yaakov, Israel (“Merhavim”).
“We believe that this delivery sets a precedent in terms of the innovative terms agreed-to with Merhavim – terms that allows researchers to explore new and complex mental health indications with less financial risk while allowing PharmAla to develop important intellectual property in a cost-effective manner,” said Nick Kadysh, CEO of PharmAla Biotech. “However it also continues to show PharmAla’s ability to work rapidly on behalf of our clients, with just 6 months between execution and delivery of the shipment – even with complexity in not only cross-border trade and tariff pressure, but also a significant conflict in the region.”
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. 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.
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