The Phase 1/2 study is recruiting patients with advanced or treatment-refractory HCC. Patients in this trial are tested at entry for infection with hepatitis C virus (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, one patient was found to be HCV-positive with a circulating viral load of >106 IU/ml at entry.
The result of the study demonstrated that over the viral load fell by >1.4 log10 in the absence of any other intervention, providing indication for a significant effect of CF102 in suppressing viral replication in the liver.
Earlier, Can-Fite BioPharma’s 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.
Can-Fite BioPharma has recently completed Phase I clinical study with CF102 under an IND in the US, showing a safety profile and a linear pharmacokinetic behavior of the drug.
Pnina Fishman, CEO of Can-Fite BioPharma, 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 hepatitis C viral 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 hepatitis C.”