Can-Fite Achieves Milestone With First Patient Dosing in Pancreatic Cancer Phase 2a Clinical Trial

Can-Fite BioPharma Ltd. recently announced the dosing of the first patient in the Phase 2a  clinical trial in patients with advanced pancreatic adenocarcinoma (NCT06387342).

“We are excited to have the first patient enrolled and hope that we will be able to demonstrate the safety and efficacy of Namodenoson in the pancreatic cancer patient population. This trial provides us the opportunity to explore our innovative treatment approach for patients who are facing significant gaps in effective treatment options,” said Dr. Michael Silverman, Can-Fite’s Medical Officer.

The Phase 2a study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first-line therapy. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

The study is being conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel and by Dr. Al Mutar from the UT Southwestern Medical Center in the US. Orphan Drug Designation has been granted lately by US FDA.

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase 2 trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) 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, liver, and inflammatory disease. The company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase 2b trial for the treatment of MASH a Phase 3 trial for hepatocellular carcinoma (HCC), and the company is planning a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the US and Europe and Fast Track Designation as a second line treatment for HCC by the US FDA. 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 1,600 patients in clinical studies to date. For more information, visit https://www.canfite.com/.