Recently, Cannabics Pharmaceuticals announced the latest research results in the treatment of colorectal cancer. The study evaluated the company's patented drug RCC-33 (the world's first cannabinoid-based anticancer drug) to treat colorectal cancer in nude mice. Efficacy. The final study results showed that RCC-33 has a significant and strong inhibitory effect on tumor growth. The tumor volume of mice exposed to RCC-33 was reduced by 33% compared with control mice (p≤0.016).
(The effect of RCC-33 on tumor formation in mice inoculated with human colorectal cancer cells)
Research design and results:
(1) Both the experimental group and the control group were inoculated with human colorectal cancer cells;
(2) Daily intraperitoneal injection of RCC-33 or sham control from day 5;
(3) After the 5th day of treatment (that is, the 10th day), observe the difference in tumor volume between the two groups. The previously published interim results showed that the tumor volume decreased by 27% after 12 days of treatment (day 17), and the p value was ≤0.022;
(4) The study ended after 16 days of treatment (day 21), and a subject in the control group reached a predetermined tumor size.
The final result showed that compared with the control group, the tumor volume of mice treated with RCC-33 was significantly reduced by 33%, with a p value of ≤0.016.
Eyal Barad, co-founder and CEO of Cannabics Pharmaceuticals, said: "A recent McKinsey report shows that according to the outlook of the oncology market, sales of therapeutic drugs in this field are expected to reach US$250 billion by 2024. Although this is ours The market that I finally see, but the current initial breakthroughs of RCC-33 are mainly focused on the development of a colorectal cancer treatment drug to meet the'massive unmet demand' with a market value of 10 billion US dollars, as McKinsey stated in the same report As stated".
Gabriel Yariv, the company’s president and chief operating officer, said: “After successfully completing this in vivo POC (proof of concept) study, the company is currently planning to complete the preparation of its product file for submission to the FDA, hoping to be able to prove that RCC- 33 functions and entered the official ranks of the FDA, and at the same time requested the pre-IND meeting of RCC-33."
What is a Pre-IND meeting: Before the initiator submits an IND application to the FDA, the initiator can request a Pre-IND meeting with the FDA review leader. The main purpose of the meeting is to evaluate and reach consensus on the design of animal research needed to support the first human trial, which can speed up the development of new drugs, effectively shorten the time for new drug approval, and save development costs.
(RCC-33 colorectal cancer preparation)
It is reported that the pre-IND meeting request with the FDA will be submitted in the first quarter of 2021, and then held in the first half of 2021. Gabriel Yariv also said: “We are providing a potential new treatment method for colorectal cancer patients. This method may have an important positive impact on a large number of patients. We are satisfied with this and look forward to combining our scientific data. Submit to regulatory agencies for review".
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