Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, announced today that it has signed an agreement with a leading clinical quality and validation processes consultancy to oversee the preparation and submission of a Pre-IND Meeting request to the FDA on its anti-tumor Drug Candidate CANNABICS™ RCC-33, the world’s first cannabinoid-based antitumor Drug Candidate for the treatment of Colorectal Cancer. The pre-IND Meeting request with the FDA is expected to be submitted during Q1 of 2021, and subsequently take place in the first half of 2021.
Eyal Barad, Cannabics Pharmaceuticals CEO, said: “The company’s decision to move forward with an FDA regulatory path for this specific product is based on a combination of factors including: the promising pre-clinical findings from our licensed in-house Drug Discovery platform in Israel, our proprietary related IP, and our positive market analysis. After many years of R&D and of developing our expertise in anti-cancer drug discovery, we are truly excited to have developed what we believe to be the world’s first cannabinoid-based medicine targeting colorectal cancer.”
Prior to filing the request for a pre-IND Meeting, the company plans to carry out a Proof of Concept (POC) study using In-vivo animal models, and a completion of the synopsis of the first in-human phase 1/2a clinical study. All this in conjunction with the development of the CANNABICS™ RCC-33’s clinical Chemistry Manufacturing & Control (CMC) protocols.
Dr. Eyal Ballan, Cannabics Pharmaceuticals CTO, said “This cooperation has enabled the company to factor in cumulative experience for approaching the FDA on a cannabinoid-based drugs for various specific indications, and we are confident that this collective experience will prove invaluable in the clinical validation process for our CANNABICS™ RCC-33.”
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 therapeutic formulations and medicines. 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.
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, 2020. 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.