Can-Fite BioPharma Ltd., a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, provided an update on its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of advanced hepatocellular carcinoma (HCC) in patients whose disease has progressed on sorafenib therapy. Can-Fite anticipates analyzing the results of this important trial before the end of the current year.
The global Phase II study is being conducted in the U.S., Europe, and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first-line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization.
The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.
The trial first opened to enrollment in December 2014 and enrollment of 78 patients was completed in August 2017. While the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo), Can-Fite notes that of the 78 subjects originally enrolled.
19 completed at least 12 cycles of treatment (each cycle is 28 days of treatment) of which three completed at least 24 cycles. The longest-treated subject has been receiving study medication for approximately 3 years.
Treatment with Namodenoson
Accumulated safety data to date continue to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.
Michael Silverman, MD, FACP, Can-Fite's Medical Director says, "While the final analysis of this trial, based on survival, has been delayed past our original projections, we are very happy that the reason for this is the unexpected longevity of patients enrolled into this trial."
"Historically, HCC patients who have failed treatment with sorafenib and are Child-Pugh B, have a very limited life expectancy. Although the trial data are still blinded, we are encouraged by the unexpectedly long survival for some patients and hope that this will translate into a survival advantage for the Namodenoson group over the placebo group, and a critical advance for treating patients with HCC."
Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.