Can-Fite Receives IRB Approval to Commence Patient Enrollment in Phase II NAFLD/NASH Trial in Q1 2017
PETACH TIKVA, Israel, Jan. 9, 2017 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory and liver diseases, cancer, and sexual dysfunction, today announced it has received approval to commence patient enrollment in a Phase II study of its liver drug candidate Namodenoson (CF102) in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH). Approval came from the Institutional Review Boards (IRBs) of Hadassah Medical Center and Rabin Medical Center, two leading medical institutions in Israel where the study will be conducted.
"Based on the swift and positive response from these leading medical institutions, we are ready to commence patient enrollment in the first quarter of 2017 in our Phase II NAFLD/NASH trial," stated Can-Fite CEO Dr. Pnina Fishman. "A growing body of preclinical data point to the potential efficacy of Namodenoson in the treatment of NAFLD/NASH and we are eager to validate these results in humans."
The approved clinical protocol is a Phase II multicenter, randomized, double-blinded, placebo-controlled, dose-finding study of the efficacy and safety of Namodenoson in the treatment of NAFLD/NASH. Approximately 60 patients with NAFLD, with or without NASH, will be enrolled in three arms, including two different dosages of Namodenoson and a placebo, given via oral tablets twice daily. The study's primary endpoints will be percent change from baseline in liver triglyceride (fat) concentration measured by nuclear magnetic resonance spectroscopy (NMRS) and safety. Secondary endpoints to be evaluated are the effects of Namodenoson on metabolic abnormalities in subjects with NAFLD, including body weight, waist circumference, serum triglyceride and high-density lipoprotein cholesterol levels, and serum liver transaminase. In addition, an assessment of the pharmacokinetics (PK) of Namodenoson and the A3 adenosine receptor (A3AR) biomarker will be evaluated prior to treatment and its correlation to patients' response to the drug will be analyzed upon study conclusion. Furthermore, the exploratory objective of this study is to evaluate the effects of Namodenoson on relevant biomarkers, such as adiponectin, leptin, C-reactive protein (CRP), and liver stiffness as determined by Fibroscan. The trial design is based on preclinical studies showing Namodenoson's efficacy in reducing liver fat in NASH models as compared to placebo, improving liver function, and regenerating liver cells.
About NAFLD/NASH
NAFLD is characterized by excess fat accumulation in the form of triglycerides (steatosis) in the liver. According to a recent study published in Hepatology, an estimated 25% of the population in the U.S. has NAFLD, with a higher prevalence in people with type II diabetes. Incidence is increasing based on rising obesity rates. NAFLD includes a range of liver diseases, with NASH being the more advanced form, manifesting as hepatic injury and inflammation. According to the NIH, the incidence of NASH in the U.S. is believed to affect 2-5% of the population. The spectrum of NAFLDs resembles alcoholic liver disease; however, they occur in people who drink little or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer.
