Can-Fite IRB OK for Treatment of Pancreatic Cancer with Namodenoson in Phase IIa Study

 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, today announced that it received an approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel where the study will be conducted. The approved protocol has been submitted now to the Ministry of Health (MOH).

"This Phase IIa study is designed as an open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment. Our positive Namodenoson data in pancreatic carcinoma experimental models together with the positive data in the Phase II advanced liver cancer study, with a patient showing overall survival of >7 years, encouraged us to initiate the current Phase IIa study," stated Can-Fite’s Medical Director Dr. Michael Silverman.

The protocol of the clinical study is CF102-222PC entitled: "A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma," ClinicalTrials.gov Identifier: NCT06387342.

The study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be 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).

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