In a July 8 research note, Dawson James Securities analyst Jason Kolbert reported that Can-Fite BioPharma Ltd. (CANF:NYSE.MKT) was green-lighted by the U.S. Food and Drug Administration and the European Medicines Agency to proceed with its proposed pivotal Phase 3 trial of Namodenoson for the treatment of patients with advanced hepatocellular carcinoma with underlying Child-Pugh B7 (CPB7) cirrhosis.
The study will evaluate Namodenoson as a second-line or third-line treatment for CPB7 patients in whom other approved therapies were not or no longer are effective. The purpose of the trial is to support a new drug application for Namodenoson, as well as eventual approval of it.
Total enrollment, to be done at multiple sites globally, is expected to be 450 patients. After 50% of enrolled patients receive treatment, an interim analysis by an independent data monitoring committee will be done.
Kolbert pointed out that an Israeli compassionate use program, in which seven patients were enrolled as of March 2021, is using Namodenoson to treat patients with liver cancer. Also, two patients with advanced liver cancer, in Can-Fite's previous Phase 2 trial, reached an overall survival of four-plus years while being treated with Namodenoson. Thus, they are continuing treatment.
As for the use of Namodenoson in nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH), Phase 2 data were positive: 25% of the group treated with 25 milligrams of the drug experienced resolution of their NASH. In comparison, in the placebo group, the number of patients who developed NASH increased 5.9% from none.
"We expect to see progression to a Phase 2b trial with liver biopsy as one of the endpoints," Kolbert commented.
Dawson James has a Buy rating and a $5 per share price target on Can-Fite, the stock of which is trading now at about $2.30 per share.
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Disclosures for Dawson James Securities, Can-Fite BioPharma, July 8, 2021
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