Algernon Announces Filing of U.S. FDA Pre-IND Meeting Request for Ifenprodil Coronavirus Trial, Expanded Access, and Emergency Use [Canadian Business Journal (Canada)]
Sanofi - American Depositary Shares (SNY)
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sanofi.com/en/investors
Company Research
Source: Canadian Business Journal
VANCOUVER, British Columbia, March 13, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “ Company In the application, the Company has requested direction regarding the use of Algernon’s planned new propriety injectable and slow release formulation as well as the use of the Company’s currently available Ifenprodil drug supply, for a US clinical trial on an emergency use basis. This filing also includes clarification of the expanded access pathway, also known as the “compassionate use” pathway. The decision to file with the U.S. FDA, was made after a recent independent study found that Ifenprodil significantly reduced ALI and improved survivability in an animal study with Asian H5N1 infected mice by 40%. Asian H5N1 is the most lethal form of influenza known to date with an over 50% mortality rate. The drug was also previously shown in a separate study to prolong survival under anoxic (low oxygen) conditions, as might occur in patients
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