Senhwa Biosciences Inc (生華生物科技) yesterday said that its partner Center For Advanced Research & Education (CARE) in Gainesville, Georgia, has filed an application to the US Food and Drug Administration (FDA) to conduct a phase II clinical trial of its new drug Silmitasertib for use by COVID-19 patients.
Since Silmitasertib, developed to treat cancer, has been proven safe in phase I human trials that Senhwa conducted on bile duct cancer patients in the US, CARE has applied to conduct the phase II clinical trial directly, Senhwa said by telephone.
The phase II trial would be led by Christopher Recknor, an internist at CARE, and the drug would be given for 14 days to 10 patients infected with COVID-19 to see if it is effective in fighting the coronavirus, a much lower number of patients than a regular phase II clinical trial, as it would be investigator-initiated, Senhwa said in a filing with the Taiwan Stock Exchange.
If the drug is proven to be effective, it would consider applying for another trial under the FDA’s emergency use authorization program, Senhwa said.
Another US partner, Banner Health, a non-profit health system based in Phoenix, Arizona, last week gained an emergency investigational new drug license, which enables it to use Silmitasertib on COVID-19 patients, Senhwa said.
Banner Health is to enroll five to 10 patients, who would be given Silmitasertib for 14 days to see if their symptoms diminish, it said.
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