PharmAla To Supply Merhavim Mental Health Centre Clinical Trial in Exchange for Full Data License, in Partnership with MAPS Israel
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.
PharmAla Biotech Holdings (CSE: MDMA) (OTC:MDXXF) ha stipulato un accordo con il Centro di Salute Mentale Merhavim di Beer Yaakov, Israele, per fornire materiali per studi clinici per la ricerca sulla psicoterapia assistita con MDMA. Lo studio, che si concentra sul trattamento del PTSD derivante da traumi sessuali precoci rispetto ai traumi in età adulta, fornirà a PharmAla diritti completi di licenza sui dati in cambio di materiali per studi clinici gratuiti.
La partnership, che include MAPS Israel, si colloca in un momento significativo dopo l'annuncio di un cessate il fuoco a Gaza. La sperimentazione rappresenta un'indagine unica sull'efficacia del MDMA nel trattamento dei traumi recenti rispetto a quelli storici. PharmAla fornirà i suoi materiali di ricerca clinica LaNeo MDMA, in attesa delle approvazioni normative.
I ricercatori possono accedere alle informazioni sulla qualità del prodotto farmacologico tramite uno strumento sul sito web di PharmAla, e l'azienda offre supporto per la conversione delle registrazioni degli studi clinici nel pacchetto Chimica, Produzione e Controllo del LaNeo MDMA. Si prevedono ulteriori collaborazioni di ricerca con MAPS Israel.
PharmAla Biotech Holdings (CSE: MDMA) (OTC:MDXXF) ha entrado en un acuerdo con el Centro de Salud Mental Merhavim de Beer Yaakov, Israel, para suministrar materiales para ensayos clínicos para la investigación de psicoterapia asistida por MDMA. El estudio, que se centra en el tratamiento del PTSD por trauma sexual temprano en comparación con el trauma en adultos, proporcionará a PharmAla derechos completos de licencia de datos a cambio de materiales para ensayos clínicos gratuitos.
La asociación, que incluye a MAPS Israel, llega en un momento significativo tras el anuncio de un alto el fuego en Gaza. El ensayo marca una investigación única sobre la eficacia del MDMA en el tratamiento de traumas recientes frente a traumas históricos. PharmAla proporcionará sus materiales de investigación clínica LaNeo MDMA, a la espera de aprobaciones regulatorias.
Los investigadores pueden acceder a la información sobre la calidad del producto farmacéutico a través de una herramienta en el sitio web de PharmAla, y la empresa ofrece soporte para convertir registros de ensayos clínicos en el paquete de Química, Fabricación y Control de LaNeo MDMA. Se anticipan colaboraciones de investigación adicionales con MAPS Israel.
PharmAla Biotech Holdings (CSE: MDMA) (OTC:MDXXF)은 이스라엘 비어 야코브의 Merhavim 정신 건강 센터와 MDMA 보조 심리치료 연구를 위한 임상 시험 자료를 제공하는 계약을 체결했습니다. 이 연구는 성적 트라우마에 대한 PTSD 치료를 성인 트라우마와 비교하여 초점을 맞추며, PharmAla는 무료 임상 시험 자료와 교환으로 데이터 라이센스 권리를 전부 받을 것입니다.
MAPS Israel을 포함한 이 파트너십은 가자 지구에서의 휴전 발표 이후 중요한 시점에 이루어졌습니다. 이 시험은 MDMA가 최근 트라우마와 역사적 트라우마 치료에 효과적인지에 대한 독특한 조사를 나타냅니다. PharmAla는 규제 승인이 대기 중인 LaNeo MDMA 임상 연구 자료를 제공할 예정입니다.
연구자들은 PharmAla의 웹사이트 도구를 통해 약품 품질 정보를 접근할 수 있고, 회사는 LaNeo MDMA 화학, 제조 및 관리 패키지로 임상 시험 등록을 전환하는 지원을 제공합니다. MAPS Israel과의 추가 연구 협력이 예상됩니다.
PharmAla Biotech Holdings (CSE: MDMA) (OTC:MDXXF) a conclu un accord avec le Centre de Santé Mentale Merhavim de Beer Yaakov, en Israël, pour fournir des matériaux d'essai clinique pour la recherche en psychothérapie assistée par MDMA. L'étude, axée sur le traitement du PTSD lié à des traumatismes sexuels précoces par rapport à des traumatismes à l'âge adulte, donnera à PharmAla des droits complets de licence sur les données en échange de matériaux d'essai clinique gratuits.
Ce partenariat, qui inclut MAPS Israel, survient à un moment important suite à l'annonce d'un cessez-le-feu à Gaza. L'essai marque une enquête unique sur l'efficacité du MDMA dans le traitement des traumatismes récents par rapport aux traumatismes historiques. PharmAla fournira ses matériaux de recherche clinique LaNeo MDMA, sous réserve des approbations réglementaires.
Les chercheurs peuvent accéder aux informations sur la qualité du produit pharmaceutique via l'outil du site web de PharmAla, et l'entreprise offre un soutien pour convertir les enregistrements d'essais cliniques dans le package Chimie, Fabrication et Contrôle de LaNeo MDMA. Des collaborations de recherche supplémentaires avec MAPS Israel sont anticipées.
PharmAla Biotech Holdings (CSE: MDMA) (OTC:MDXXF) hat eine Vereinbarung mit dem Merhavim Zentrum für psychische Gesundheit in Beer Yaakov, Israel, getroffen, um Materialien für klinische Studien zur Erforschung der MDMA-unterstützten Psychotherapie bereitzustellen. Die Studie, die sich auf die PTSD-Behandlung bei frühem sexuellem Trauma im Vergleich zu Erwachsenentrauma konzentriert, wird PharmAla volle Lizenzrechte an den Daten im Austausch für kostenlose klinische Studienmaterialien gewähren.
Die Partnerschaft, die MAPS Israel umfasst, kommt zu einem bedeutenden Zeitpunkt nach der Ankündigung eines Waffenstillstands im Gazastreifen. Die Studie markiert eine einzigartige Untersuchung der Wirksamkeit von MDMA bei der Behandlung von aktuellen im Vergleich zu historischen Traumata. PharmAla wird seine LaNeo MDMA klinischen Forschungsunterlagen bereitstellen, vorbehaltlich der behördlichen Genehmigungen.
Forscher können über das Werkzeug auf der PharmAla-Website auf Informationen zur Produktqualität zugreifen, und das Unternehmen bietet Unterstützung bei der Umwandlung von klinischen Studienregistrierungen in das LaNeo MDMA Chemie-, Herstellungs- und Kontrollpaket. Zusätzliche Forschungskooperationen mit MAPS Israel werden erwartet.
- None.
- None.
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?
How will PharmAla (MDXXF) benefit from the Merhavim clinical trial agreement?
What distinguishes this MDXXF clinical trial from other PTSD studies?
What support does PharmAla (MDXXF) offer to researchers for clinical trials?
How can researchers access PharmAla's (MDXXF) clinical trial materials?
