FDA Grants Orphan Drug Designation to Can-Fite’s Namodenoson for Pancreatic Cancer

Can-Fite BioPharma Ltd. recently announced the its oncology drug candidate, Namodenoson, has been granted Orphan Drug Designation by the US 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 (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions).

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,” said Can-Fite CEO Motti Farbstein.”

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR), on the surface of liver and pancreatic cancer cells. Namodenoson, induces  apoptosis of these cancer cell types. Namodenoson was evaluated in Phase 2 liver cancer 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 NASH 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 www.canfite.com.