Can-Fite delays phase 2 trial of liver cancer drug Namodenoson

However, the company is positive on the outcome of the trial with its final analysis, which is based on survival, delayed due to the unexpected longevity of the participating patients.  

Can-Fite said that it now expects analyzing the results of the key trial in patients with advanced hepatocellular carcinoma (HCC) before the year end.

A small orally bioavailable drug, Namodenoson binds with high affinity and selectivity to the A3 adenosine receptor (A3AR), which is highly expressed in diseased cells while low expression is found in normal cells, said the company.

The global mid-stage trial for Namodenoson, being held in the US, Europe and Israel, is evaluating it for the treatment of advanced HCC in patients whose disease has progressed on Nexavar (sorafenib) therapy.

In the ongoing phase 2 trial, patients with advanced HCC, Child Pugh B, who did not respond to Nexavar as a first line treatment are being treated with 25 mg of oral Namodenoson or placebo, twice daily using a 2:1 randomization.

Overall survival (OS) is the primary endpoint of the mid-stage trial with the secondary endpoints being progression free survival (PFS), safety, and the relationship between outcomes and A3AR expression.

The trial started enrolling patients in December 2014 and in August 2017, Can-Fite completed enrollment of 78 patients.

Can-Fite said that out of the 78 patients originally enrolled, 19 completed at least 12 cycles of treatment with each cycle being 28 days of treatment. Out of the 19, three completed at least 24 cycles.

The Israeli firm said that the longest-treated patient has been subjected to Namodenoson treatment for nearly three years.

Can-Fite medical director Michael Silverman said: “Historically, HCC patients who have failed treatment with sorafenib and are Child Pugh B, have 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.”

Namodenoson has an orphan drug designation in Europe and the US. It also has a fast track designation in the US as a second line treatment for HCC.

Image: Can-Fite is evaluating Namodenoson for the treatment of advanced hepatocellular carcinoma. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.