Can-Fite BioPharma’s (NYSE MKT:CANF; TASE:CFBI) drug candidate, CF102, which is currently in Phase 2 trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, will be expanded into the treatment for non-alcoholic steatohepatitis (NASH).
NASH is characterized by excess fat in the liver along with inflammation and liver damage. While it resembles alcoholic liver disease, it occurs in people who drink little or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. The addressable pharmaceutical market for NASH is estimated to reach $35-billion to $40-billion by 2025.
In a statement, CEO, Dr. Pnina Fishman, said results from the company’s recently concluded preclinical study of CF102 in liver disease revealed compelling data. Based on these findings, Can-Fite has filed a patent for CF102 in the treatment of NASH.
“Because the prevalence of NASH continues to grow and no treatment currently exists, our data support the development of CF102 for the treatment of NASH,” she added.
Dr. Fishman said CF102 revealed its capability to improve liver pathology in a NAFLD (non-alcoholic fatty liver disease)/diabetes animal model of NASH. In prior preclinical studies, CF102 has shown efficacy in the treatment of liver regeneration and function following liver surgery.
Can-Fite currently has an IND application active with the FDA for CF102. CF102 is currently being evaluated as a second-line treatment for HCC through a global Phase 2 trial. Data from the Phase 2 HCC study are expected in 2016.
Can-Fite has received orphan drug designation for CF102 for this indication in Europe and the U.S., as well as fast track status in the U.S.