8-Year Survival and Complete Cure of Advanced Liver Cancer with Can-Fite's Namodenoson

Can-Fite BioPharma Ltd., a leading biotechnology firm based in Ramat Gan, Israel, has announced a significant milestone in its ongoing efforts to combat advanced liver cancer. The company revealed that a patient under its compassionate use program for Namodenoson has achieved a remarkable overall survival period of eight years with a complete remission of the disease.

This patient, who had severe liver cancer, participated in Can-Fite’s earlier Phase II clinical trial. The individual continues to receive Namodenoson and has experienced an outstanding recovery, evidenced by the disappearance of ascites, restored normal liver function, and an exceptional quality of life. This case is categorized as a long-term complete response, a notable achievement in the fight against liver cancer.

Can-Fite is currently conducting a pivotal Phase III clinical trial for patients with advanced hepatocellular carcinoma (HCC) across Israel, Europe, and the United States. This study aims to validate the effectiveness of Namodenoson as a second or third-line treatment for HCC and is conducted with the endorsement of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Namodenoson, due to its promising therapeutic profile, has been granted Orphan Drug status by both the FDA and EMA, and it also has Fast Track Status from the FDA for HCC treatment. Presently, the compassionate use program for this drug is operational in Israel and Romania.

Professor Salomon Stemmer from the Institute of Oncology at Rabin Medical Center, Israel, highlighted the drug's notable safety and anti-cancer attributes. He expressed optimism that the ongoing Phase III trial would replicate the positive outcomes observed in the long-term patient responder, attributing this to Namodenoson's unique ability to target tumor cells selectively while preserving healthy liver cells.

Liver cancer is a significant global health challenge, responsible for over 700,000 deaths annually according to the American Cancer Society. HCC, a particularly aggressive form of liver cancer, is associated with poor survival rates. The development and approval of effective treatments like Namodenoson are crucial, with market projections estimating the HCC treatment sector to grow to $6.1 billion by 2027 in the G8 countries.

Namodenoson is an orally administered drug that specifically targets the A3 adenosine receptor (A3AR). This receptor is highly expressed in cancerous cells but shows low expression in normal cells, which accounts for the drug's high safety profile. In addition to liver cancer, Namodenoson has been investigated for other conditions, including non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), in Phase II trials.

Can-Fite BioPharma Ltd. is at the forefront of developing innovative treatments for cancer, liver, and inflammatory diseases. The company’s advanced clinical development pipeline includes Piclidenoson, which has shown positive results in a Phase III trial for psoriasis, and Namodenoson, which is being evaluated not only for HCC but also for NASH and other cancers like pancreatic, colon, prostate, and melanoma. Another drug candidate, CF602, is being developed for erectile dysfunction.

Can-Fite’s novel drugs have demonstrated excellent safety across extensive clinical trials involving over 1,600 patients. The company's strategic focus and robust pipeline position it as a key player in addressing significant unmet medical needs in oncology and inflammatory diseases.