CNBX Selects API Supplier Purisys to Support Planned IND Fillings and Phase I/II (a) Clinical Trials
Cannabics Pharmaceuticals (OTCQB: CNBX) announced a collaboration with Purisys for the supply of GMP-grade APIs for its colorectal cancer drug candidate, RCC-33. The agreement includes support for the IND filing process with the FDA. This partnership is aimed at ensuring high purity and regulatory compliance. Purisys, recognized for its expertise in cannabinoid APIs, will assist CNBX in launching Phase I/II clinical trials in 2022. This collaboration marks a significant development in CNBX's efforts to advance its cannabinoid-based cancer treatments.
- Agreement with Purisys for supply of GMP-grade APIs for RCC-33.
- Support for IND filing process with the FDA included.
- Preparation for Phase I/II clinical trials planned for 2022.
- None.
TEL AVIV, Israel and BETHESDA, Md., Nov. 4, 2021 /PRNewswire/ -- Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, announced today that it has signed an agreement with Purisys, a leading Active Pharmaceutical Iingredient (API) manufacturer, for supply of Good Manufacturing Practice (GMP) grade APIs required for the manufacturing of RCC-33, the company's colorectal cancer treatment drug candidate. Under said agreement, Purisys will also support CNBX throughout an IND filing process, including providing all necessary and related information concerning Chemistry Manufacturing and Controls (CMC) in the form of a comprehensive technical package to be presented to the FDA. APIs supplied under said agreement will be used by Company in Phase I/II (a) clinical studies that it is planning to launch in 2022.
Gabriel Yariv, Cannabics Pharmaceuticals' Executive Chairman, said: "We have been carefully searching for an API supplier to support our planned IND fillings for quite some time now, and in Purisys we found all the various parameters we were looking for. Purisys is the leading provider of synthetically-derived cannabinoid APIs to researchers and product developers looking to navigate health authority-regulated pathways. Accordingly, we became confident that Purisys will be able to provide us with an ultra-high purity API product on the one hand, and with all the necessary regulatory and CMC related support required for our planned approach of the FDA on the other. I am pleased to report that this agreement marks an important step in the right direction for the company."
Josh Hoerner, Purisys LLC. General Manager commented: "We are excited about the opportunity to provide pharmaceutical grade ultra-pure cannabinoid APIs to Cannabics Pharmaceuticals for their innovative drug candidate for the treatment of colorectal cancer. To that end, the pharmaceutically-compliant cannabinoid APIs produced by Purisys are backed by state-of-art manufacturing technology, a commercial-scale pharmaceutical supply chain, comprehensive technical files and strong regulatory CMC support. CNBX is a leader in the field of cannabinoid-based anti-cancer treatment, with a growing pipeline of additional drug candidates, and we look forward to establishing a long and fruitful relationship with the company, one that could potentially help bring new, critical treatment alternatives to large groups of patients around the globe."
About Purisys:
Headquartered in Athens, Georgia, Purisys is a leading provider of API contract manufacturing and development services including custom synthesis and analytical development services for clinical stage compounds. Purisys' expertise includes extensive scientific and regulatory know-how, state-of-the-art manufacturing technologies and a track record of delivering projects on time. Purisys can develop a broad range of APIs including clinical stage compounds used to treat a variety of indications including therapeutic areas such as cardiovascular, CNS and oncological drugs. The company has a long-term, successful regulatory track record in the pharmaceutical industry with a commitment to high purity, consistency, and compliance. Purisys also has a comprehensive set of CDMO offerings and a robust reference standard program to support the pharmaceutical industry deliver innovative new therapies to patients.
About Cannabics Pharmaceuticals:
Cannabics Pharmaceuticals Inc. (OTCQB: CNBX) is a U.S. public company and a global leader in the development of cancer related cannabinoid-based medicine. The Company's R&D is based in Israel, where it is licensed by the Ministry of Health to conduct scientific and clinical research on cannabinoid formulations and cancer. For more information, please visit www.cannabics.com. For the latest updates on Cannabics Pharmaceuticals follow the Company on Twitter @Cannabics, Facebook @CannabicsPharmaceuticals, LinkedIn, and on Instagram @Cannabics_Pharmaceuticals.
Read more:
Recent expansion of Company's IP Portfolio with filing of 2 new Provisional Patents; Recent expansion of Cannabics Pharmaceuticals' Board of Advisors to include: Prof. Caroline Robert (MD, Ph.D.), a Melanoma expert, and, Dr. Sigal Tavor (MD), a Hematology expert, along with Prof. Amos Toren (MD), Prof. Zamir Halpern (MD), Prof. Noam Shomron (Ph.D.), Dr. Erez Scapa (MD), Dr. Dana Ben-Ami Shor (MD), Dr. Sigalit Arieli-Portnoy (Ph.D.) and Dr. Tal Mofkadi (Ph.D.); Recent expansion of Cannabics Pharmaceuticals' Board of Directors to include: Dr. Inbar Maymon-Pomeranchik (Ph.D.), and Dr. Gil Feiler (Ph.D.) as Independent Directors.
Disclaimer:
Certain statements contained in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. Such statements include but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions. The statements in this release are based upon the current beliefs and expectations of our Company's management and are subject to significant risks and uncertainties. Actual results may differ from those outlined in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials and other studies, the challenges inherent in new product development initiatives, the effect of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and regulation, potential litigation by or against us, any governmental review of our products or practices, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission including, without limitation, our latest 10-Q Report filed July 14th, 2021. We undertake no duty to update any forward-looking statement or any information contained in this press release or other public disclosures at any time. Finally, the investing public is reminded that the only announcements or information about Cannabics Pharmaceuticals Inc., which are condoned by the Company, must emanate from the Company itself and bear our name as its source.
For more information about Cannabics:
Cannabics Pharmaceuticals Inc.
+1 (877) 424-2429
info@cannabics.com
https://www.cannabics.com
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SOURCE Cannabics Pharmaceuticals Inc.
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