Can-Fite BioPharma (NYSE American: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced that the final data analysis from its Phase 2 study of Namodenoson in the treatment of patients with non-alcoholic fatty liver disease (NAFLD) with or without non-alcoholic steatohepatitis (NASH) has been completed. As a whole, the data show that Namodenoson at the 25 mg dose produced statistically significant results in all measures of efficacy, while also having a strong safety profile and well tolerated.
Why it Matters: New data resulting from the final analysis included additional results from MRI-PDFF (proton density fat fraction on magnetic resonance imaging) and liver stiffness measured by CAP Fibroscan. An evaluation based on per patient liver volume revealed that liver fat volume decreased in the Namodenoson treated groups vs. the placebo (12.5 mg=81.2; 25 mg =102.1, vs. placebo= 33.0) with a high significance (12.5mg p=0.036; 25mg p=0.027, respectively). The percentage of fat volume decrease was also statistically significant, with the Namodenoson 12.5 mg group declining by 3.68%, and the 25 mg group declining by 4.33% vs. the placebo at 2.61% (25 mg p=0.036). This provides additional support for the anti-steatotic effect of Namodenoson and additional assurance that 25 mg is the more efficacious dose.
Key Quote: “We are very pleased with these compelling data. The next clinical trial protocol to advance Namodenoson in the treatment of NASH and NAFLD is now being developed. With the clear need for approved drugs in this indication, I believe distribution partners for Can-Fite will likely take notice of these results.” – Prof. Rifaat Safadi, Principal Investigator
Backstory: Can-Fite is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and COVID-19. The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Piclidenoson has been approved for a pilot clinical trial in Israel to treat COVID-19 infected patients with moderate-to-severe symptoms. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.
Disclosure
Can-Fite Biopharma (CANF) is a client of RedChip Companies, Inc. CANF agreed to pay RedChip Companies, Inc. a cash fee of $5,000 monthly, beginning in August 2019, and 16,500 shares of CANF Rule 144 stock for 6 months of RedChip investor awareness services and consulting services.
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