Cannabics Pharmaceuticals has signed an agreement with a 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 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.
"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," Eyal Barad, Cannabics Pharmaceuticals CEO, said.
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.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"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," Dr. Eyal Ballan, Cannabics Pharmaceuticals CTO, said.