Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced in a news release it launched a clinical research program to evaluate NP-120 (Ifenprodil) in pancreatic cancer.
The company chose to pursue a clinical program in pancreatic cancer after Ifenprodil was shown to cause "a significant anti-tumor effect" in an animal study, as reported in the journal, Clinical Pharmacology: Advances and Applications, the news release noted. The murine study showed that Ifenprodil significantly and quickly shrank the average solid pancreatic tumor size by almost half by day three. In contrast, during the same period in the untreated group, the average tumor size doubled.
"Ifenprodil's anti-tumor effect in this study is very impressive when you consider it does not appear to have the serious side effects typically seen with other chemotherapy agents," Moreau added.
Pancreatic cancer is designated as an orphan disease and has a five-year survival rate of only 7.9%, the company reported.
Another factor in Algernon's decision to expand its clinical investigation is that Ifenprodil has been shown in preclinical and clinical studies "significant effectiveness in treating" various diseases, including cancers, chronic disorders and psychological disorders like addiction and post-traumatic stress disorder, in certain preclinical and clinical studies.
In addition, data from Algernon's own multinational clinical trial of Ifenprodil in COVID-19 were positive, encouraging to the company. In the study, the NMDA receptor antagonist reduced interleukin 6 at day five in the cohort receiving 20 milligrams of Ifenprodil. Interleukin-6 is a pro-inflammatory cytokine involved in numerous diseases, including pancreatic cancer.
The next step is for Algernon to complete and file a request for a pre-investigational new drug application meeting with the U.S. Food and Drug Administration. The purpose of the meeting is to gain insight into how best to advance Ifenprodil into clinic trials in this cancer indication. The biopharma also plans to eventually apply for fast track status and orphan disease and breakthrough therapy designations.
"Our business plan is to have upwards of three to four Phase 2 trials underway in 2022," Algernon CEO Christopher J. Moreau said in the release.
As for its supply of Ifenprodil, Algernon "has synthesized its own supply of Ifenprodil cGMP grade active pharmaceutical ingredient and has now begun the process of advancing to the finished product stage with new formulations planned."
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