PharmAla to supply Mt. Sinai Hospital with LaNeo MDMA
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) has been contracted to supply its GMP LaNeo™ MDMA to a clinical trial at Mt. Sinai Health System. The company, focused on MDMA research and manufacturing, will support Mt. Sinai's researchers with high-quality clinical trial drug product. PharmAla has launched a new tool on their website for researchers to access drug product quality information.
Additionally, PharmAla announced the termination of its supply agreement with CCrest Labs, which was previously contracted to distribute PharmAla's MDMA to doctors under the Special Access Program. The company will now rely on other contracted distributors for this purpose.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) è stata incaricata di fornire il suo MDMA LaNeo™ GMP per uno studio clinico presso il Mt. Sinai Health System. L'azienda, focalizzata sulla ricerca e produzione di MDMA, supporterà i ricercatori di Mt. Sinai con un prodotto farmacologico di alta qualità per le prove cliniche. PharmAla ha lanciato un nuovo strumento sul proprio sito web per consentire ai ricercatori di accedere alle informazioni sulla qualità del prodotto farmacologico.
Inoltre, PharmAla ha annunciato la risoluzione del suo contratto di fornitura con CCrest Labs, che in precedenza era stata incaricata di distribuire l'MDMA di PharmAla ai medici nel contesto del Programma di Accesso Speciale. L'azienda farà ora affidamento su altri distributori contrattati per questo scopo.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) ha sido contratada para suministrar su MDMA LaNeo™ GMP a un ensayo clínico en el Sistema de Salud Mt. Sinai. La empresa, centrada en la investigación y fabricación de MDMA, apoyará a los investigadores de Mt. Sinai con un producto farmacológico de calidad superior para el ensayo clínico. PharmAla ha lanzado una nueva herramienta en su sitio web para que los investigadores accedan a información sobre la calidad del producto farmacéutico.
Además, PharmAla anunció la terminación de su acuerdo de suministro con CCrest Labs, que anteriormente estaba contratada para distribuir el MDMA de PharmAla a médicos bajo el Programa de Acceso Especial. La empresa ahora dependerá de otros distribuidores contratados para este propósito.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF)는 GMP LaNeo™ MDMA를 공급하도록 계약을 체결했습니다 이는 Mt. Sinai Health System에서 임상 시험을 위한 것입니다. MDMA 연구 및 제조에 주력하는 이 회사는 Mt. Sinai의 연구자들에게 고품질의 임상 시험 약물을 지원할 것입니다. PharmAla는 연구자들이 약물 품질 정보를 이용할 수 있도록 웹사이트에 새로운 도구를 출시했습니다.
또한 PharmAla는 CCrest Labs와의 공급 계약 종료를 발표했습니다, 이는 이전에 PharmAla의 MDMA를 의사들에게 특수 접근 프로그램 하에 배포하기 위해 계약된 바 있습니다. 이 회사는 이제 이 목적을 위해 다른 계약된 유통업체에 의존하게 될 것입니다.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) a été
De plus, PharmAla a annoncé la résiliation de son contrat de fourniture avec CCrest Labs, qui avait été précédemment mandaté pour distribuer le MDMA de PharmAla aux médecins dans le cadre du Programme d'Accès Spécial. L'entreprise comptera désormais sur d'autres distributeurs sous contrat pour cet objectif.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) wurde beauftragt, sein GMP LaNeo™ MDMA für eine klinische Studie am Mt. Sinai Health System zu liefern. Das Unternehmen, das sich auf MDMA-Forschung und -Herstellung konzentriert, wird die Forscher von Mt. Sinai mit qualitativ hochwertigen klinischen Studienprodukten unterstützen. PharmAla hat ein neues Tool auf seiner Website eingeführt, das Forschern den Zugang zu Informationen über die Qualität des Arzneimittels ermöglicht.
Darüber hinaus gab PharmAla die Beendigung seines Liefervertrags mit CCrest Labs bekannt, das zuvor beauftragt war, PharmAlas MDMA im Rahmen des Programms für besonderen Zugang an Ärzte zu verteilen. Das Unternehmen wird nun auf andere beauftragte Vertriebsunternehmen angewiesen sein.
- Secured contract to supply LaNeo MDMA for clinical trial at prestigious Mt. Sinai Health System
- Launched new tool for researchers to access drug product quality information
- Potential for future supply contracts with Mt. Sinai Health System
- Termination of supply agreement with CCrest Labs
TORONTO, Oct. 21, 2024 (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 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.
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.
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