Toronto, ON – Oct 21, 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 excited to announce that it has been contracted as a supplier of its GMP LaNeo™ MDMA to a clinical trial at Mt. Sinai Health System.
“We’re looking forward to supporting the team at Mt. Sinai Health System with high quality clinical trial drug product,” said Nicholas Kadysh, CEO, PharmAla Biotech. “Sinai houses some of the best researchers in the world, executes a significant amount of work for the Veterans Affairs administration (the “VA”), and has fantastic new facilities for MDMA-assisted therapy. We will work diligently to supply both the current contract, and any future needs that they may have for GMP MDMA drug product.”
Researchers can access a new tool, offered at https://pharmala.ca/clinical-trials, which provides access to drug product quality information, which researchers can examine directly. PharmAla has, and will continue to support its research customers in converting their clinical trial registrations and IRB approvals to the LaNeo MDMA Chemistry, Manufacturing and Control package.
Termination of Contract with CCrest Labs
PharmAla and CCrest Labs have terminated their supply agreement. CCrest was contracted in 2022 to distribute PharmAla’s MDMA to doctors under the Special Access Program. PharmAla will rely on other contracted distributors to complete this work moving forward.
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