CANF News & Events

Can-Fite BioPharma announced results from its Phase IIa open-label study evaluating namodenoson in patients with advanced pancreatic ductal adenocarcinoma who had progressed following prior systemic therapies. The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases. The study enrolled 20 patients with advanced PDAC who had received one or more prior lines of therapy. Patients represented a high-risk population, including individuals with varying performance status and advanced metastatic disease. Secondary endpoints included overall survival and progression-free survival. Survival follow-up remains ongoing, with 1/3 of patients currently alive at the time of data cut-off. As follow-up continues, survival outcomes are expected to further mature and will be announced during upcoming scientific meetings.Namodenoson is a highly selective A3 adenosine receptor agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer. Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of pancreatic cancer.

Can-Fite BioPharma announced the publication of a peer-reviewed study in the International Journal of Obesity demonstrating the anti-obesity effect of namodenoson, the Company's lead drug candidate. The article, titled "The anti-obesity effect of namodenoson, an A3 adenosine receptor agonist," is now available online as an Open Access publication. The study evaluated the effects of namodenoson in adipocytes in vitro and in a murine high-fat diet model of obesity. The findings are consistent with previously reported data from a Phase IIa clinical study in patients with metabolic dysfunction-associated steatohepatitis, in which treatment with namodenoson for three months was associated with reductions in liver fat and body weight. A Phase IIb MASH study is currently enrolling patients and is designed to evaluate effects on inflammation, fibrosis, steatosis, and body weight.

Can-Fite BioPharma announced that the Canadian Patent Office has issued a notice of allowance for Canadian Patent Application No. 3,126,002, titled "An A3 adenosine receptor ligand for use for achieving a fat loss effect. The patent covers the use of Namodenoson, Can-Fite's orally bioavailable A3 adenosine receptor agonist, for reducing fat mass and body weight, providing intellectual property protection in Canada for its development as an anti-obesity therapy. Can-Fite already holds corresponding patents in the United States and Australia for the use of Namodenoson in obesity and metabolic disorders. Namodenoson is currently in clinical development for Metabolic Dysfunction-Associated Steatohepatitis, advanced liver cancer, and pancreatic cancer, and has demonstrated an excellent safety profile across multiple clinical studies following oral administration. The anti-obesity patent application is based on data demonstrating that treatment of fat cells with Namodenoson reduced fat levels via the increase of the hormone adiponectin, a regulator of fat production in the body. Namodenoson also reduced body weight in an experimental animal model of obesity, induced by high fat diet. In a MASH Phase IIa study, in patients treated with Namodenoson, a 2.3% weight loss has been observed after 3 months with a significant increase in serum adiponectin levels.

Can-Fite BioPharma announced that a patient with advanced decompensated liver cirrhosis who was treated with Namodenoson subsequently underwent a successful liver transplantation. The patient received Namodenoson treatment under a compassionate use framework while suffering from liver disease and complications consistent with decompensated cirrhosis. Throughout the treatment period, Namodenoson contributed to clinical stabilization, allowing the patient to remain a suitable candidate for liver transplantation until a compatible donor organ became available, ultimately resulting in a successful, life-saving liver transplantation. While this is a single case, the outcome suggests a potential supportive role for Namodenoson in patients with severe liver dysfunction awaiting transplantation.