Can-Fite BioPharma Ltd. announced the company’s oncology drug candidate, Namodenoson, has been granted Orphan Drug Designation by the FDA for the indication of pancreatic cancer, one of the most aggressive malignancies. The designation as an orphan drug will provide among others, potential for market exclusivity for seven years after approval and several and regulatory advantages.
Can-Fite is now completing all the preparatory work for a Phase II study in patients with pancreatic cancer. The study will be a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient 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).
”We are advancing our plans to start our Phase 2 study in pancreatic cancer and aim to commence the study by the end of year; we are thrilled that the FDA has granted Orphan Drug Status,” stated Can-Fite CEO Motti Farbstein”.
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