A developer of cannabinoid-based therapies has begun the next phase of testing for a cannabis-based anti-tumor treatment for colon cancer.
Maryland-based Cannabics Pharmaceuticals today announced the initiation of a series of proof of concept (POC), in-vivo animal model studies to test the efficacy of its proprietary RCC-33 formulation on mice transplanted with colorectal cancer tumor cell lines.
Cannabics’ R&D operations are based in Israel, where they have approval from the Ministry of Health to conduct scientifiuc and clinical research on cannabinoid formulations and cancer.
Cannabics will include the animal study results in the data package that the company is preparing to submit to the United States Food and Drug Administration (FDA), along with a request for a pre-IND meeting.
Colorectal cancer is the third most commonly diagnosed cancer and the second most lethal cancer worldwide, with 1,848,518 cases and 880,792 deaths in 2018.
In August, Cannabics revealed that it would be establishing a division for RCC-33 as the company began preparing to expand its clinical validation efforts for the formulation.
“We are proud to be at the forefront of cannabinoid-based drug discovery and clinical development,” says Cannabics President and COO Gabriel Yariv. “Our aim is to be the first company to bring a comprehensive pre-clinical data package before the FDA in support of a cannabinoid-based Drug Candidate for the treatment of colorectal cancer. Today marks and important step in that direction.”
Animal studies for RCC-33 follow the completion of in-vitro studies of the formulation on colorectal cancer cell lines and human biopsies that Cannabics obtained under Helsinki Approved Protocols at the company’s laboratory in Israel.
In November, Cannabics concluded the pre-clinical study for RCC-33 on human biopsies, the results of which showed an anti-tumor synergistic effect that confirmed data previously obtained by Cannabics.
Cannabics CTO Eyal Ballan says that the start of in-vivo animal studies signals an important milestone for the company as the start of the clinical path that the company specifically designed to present their RCC-33 drug candidate to the FDA for review.