On November 14, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported the dosing of the first patient in the Phase IIa clinical trial in patients with advanced pancreatic adenocarcinoma (NCT06387342) (Press release, Can-Fite BioPharma, NOV 11, 2024, View Source [SID1234648081]).
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"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," stated Dr. Michael Silverman, Can-Fite’s Medical Officer.
The Phase IIa 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.
About Namodenoson
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 II 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.