Can-Fite's CF102 reports significant decrease in HCV viral load in patient with HCC...

Can-Fite BioPharma reported that a significant decrease in HCV viral load was noted in a patient with liver cancer treated daily, orally with CF102, within the framework of a Phase I/II clinical study in liver cancer (hepatocellular carcinoma, HCC) patients.

The Phase I/II study is enrolling patients with advanced or treatment-refractory HCC. As chronic viral hepatitis is one of the most important causes for HCC, patients in this trial are tested at entry for infection with HCV. Although not part of the primary trial objectives, those patients who are HCV-positive are retested periodically to gauge the effect of CF102 on HCV infection in this population. In the first, lowest-dose, cohort of the trial, 1 patient was found to be HCV-positive with a circulating viral load of >106 IU/mL at entry. Over the course of treatment with CF102, the viral load fell by >1.4 log10 in the absence of any other intervention, providing a very strong indication for a significant effect of CF102 in suppressing viral replication in the liver.

Can-Fite CEO, Dr. Pnina Fishman said, “these results are especially encouraging for 2 reasons. First, they validate our extensive pre-clinical data indicating CF102’s effectiveness in treating liver disease in general, and HCV infection in particular. Second, this result is encouraging for Can-Fite’s other ongoing CF102 trial, a Phase 1/2 study in patients with HCV infection. We are optimistic that CF102 can become part of the treatment arsenal for the millions of people worldwide who suffer from HCV.”

Previously, the company reported that preclinical studies have suggested that the drug is active against HCV via inhibition of NS5, RNA dependent RNA polymerase. CF102 was also found to trigger programmed cell death (apoptosis) of liver cancer cells. The company had announced the successful completion of a Phase I clinical study with CF102 under an IND in the US, showing a safety profile and a linear pharmacokinetic behaviour of the drug.