PharmAla To Supply Merhavim Mental Health Centre Clinical Trial in Exchange for Full Data License, in Partnership with MAPS Israel

Rhea-AI Summary

PharmAla Biotech Holdings (CSE: MDMA) (OTC:MDXXF) has entered into an agreement with Merhavim Mental Health Centre of Beer Yaakov, Israel, to supply clinical trial materials for MDMA-assisted psychotherapy research. The study, focusing on PTSD treatment for early sexual trauma compared to adult trauma, will provide PharmAla with full data licensing rights in exchange for free clinical trial materials.

The partnership, which includes MAPS Israel, comes at a significant time following the announcement of a cease-fire in Gaza. The trial marks a unique investigation into MDMA's effectiveness in treating recent versus historical trauma. PharmAla will provide its LaNeo MDMA Clinical Research Materials, pending regulatory approvals.

Researchers can access drug product quality information through PharmAla's website tool, and the company offers support for converting clinical trial registrations to the LaNeo MDMA Chemistry, Manufacturing and Control package. Additional research collaborations with MAPS Israel are anticipated.

TORONTO, Jan. 20, 2025 (GLOBE NEWSWIRE) -- 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.

About PharmAla

PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) 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 as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. 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.

For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: www.PharmAla.ca

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

FAQ

What is the purpose of PharmAla's (MDXXF) clinical trial partnership with Merhavim Mental Health Centre?

The partnership aims to study MDMA-assisted psychotherapy for PTSD, specifically comparing early sexual trauma to adult trauma, with PharmAla providing free clinical trial materials in exchange for full data licensing rights.

How will PharmAla (MDXXF) benefit from the Merhavim clinical trial agreement?

PharmAla will receive full licensing rights to all data generated from the clinical trial for regulatory and commercial purposes, in exchange for providing their LaNeo MDMA materials at no cost.

What distinguishes this MDXXF clinical trial from other PTSD studies?

This is reportedly the first trial to specifically examine MDMA's efficacy in treating recent trauma versus aged trauma in PTSD patients.

What support does PharmAla (MDXXF) offer to researchers for clinical trials?

PharmAla provides access to drug product quality information through their website tool and assists in converting clinical trial registrations to their LaNeo MDMA Chemistry, Manufacturing and Control package.

How can researchers access PharmAla's (MDXXF) clinical trial materials?

Qualified researchers can contact sales@pharmala.ca and access drug product quality information through PharmAla's website tool at pharmala.ca/clinical-trials.