Israeli biotech Can-Fite BioPharma is hoping to trudge ahead with a late-stage study of its experimental cancer drug, despite it failing a mid-stage study in patients with advanced liver cancer.
The drug, namodenoson, was being tested in a 78-patient Phase II study in patients with advanced liver cancer in patients with underlying cirrhosis, whose disease had progressed despite firstline treatment with Bayer’s Nexavar.
Can-Fite’s drug missed the main goal of overall survival; in fact namodenoson-treated patients actually performed worse: median OS was 4.1 months for namodenoson versus 4.3 months for placebo.
Shares of the company $CANF tumbled more than 27% in pre-market trading to 94 cents on Tuesday.
Patients with advanced liver cancer are divided into subclasses based on cirrhosis severity, using a widely used tool as measured by the Child-Pugh score, which was originally developed in 1973 to estimate the risk of operative mortality in patients with bleeding esophageal varices.
In the trial, patients given the Child Pugh B (CPB) score were enrolled, and within that category patients were further divided into three subcategories denoting increasing severity — CPB7, CPB8, and CPB9.
Secondary study endpoints included safety, progression free survival (PFS) and the percentage of patients whose tumors partially shrank after treatment, or partial response (PR).
CPB7 patients — the largest subcategory in the trial (n=56) — did live longer when given namodenoson. Namodenoson-treated patients (n=34) experienced median OS of 6.8 months compared to placebo (n=22) with 4.3 months. Similarly, for these patients, PFS was 3.5 months in the namodenoson-treated group versus 1.9 months in the placebo group.
For the entire patient population, 9% of those treated by namodenoson achieved PR versus none in the placebo group.
The drug has already been granted fast-track status by the FDA, and Can-Fite appeared encouraged by the data set.
“These data strongly support the progression into Phase III,” Can-Fite said in a statement, adding that the company plans to discuss the results with regulatory agencies to determine its next steps.
“The global incidence of liver cancer continues to increase and has more than tripled in the United States over the last three decades, and currently there are no recommended systemic treatment options for patients with advanced HCC and severe liver dysfunction (Child Pugh B),” said Josep Llovet, founder of the Liver Cancer program at Mount Sinai, in a statement. “(T)he current data from this Phase II trial suggest a signal of efficacy that supports continuing the development of Namodenoson with a Phase III study in this population. I will be happy to help with the design of the Phase III and serve as the principal investigator of the trial.”
Can-Fite’s tech platform is based on research that points to targeting the Gi protein coupled A3 adenosine receptor (A3AR), which is understood to be overexpressed in inflammatory and cancer cells. The company has a trifecta of drugs in development, including namodenoson, which is also being tested for use in NASH.
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