Can-Fite Provides Update on Phase 3 Liver Cancer Study

Can-Fite BioPharma Ltd., a biotechnology firm listed on the NYSE American and TASE, has provided an update on its primary oncological drug candidate, Namodenoson, which is being developed to treat advanced liver cancer. The pivotal Phase 3 study of Namodenoson now boasts 31 active recruiting centers across Europe, Israel, and the United States. The drug has been granted Orphan Drug status by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, and it has also secured Fast Track Status from the FDA. Additionally, a compassionate use program for Namodenoson is ongoing in Israel and Romania.

The previous Phase 2 study of Namodenoson demonstrated promising results for patients with advanced liver cancer. Patients experienced prolonged survival and maintained a good quality of life. Notably, two patients showed clearance of peritoneal carcinomas, and one patient had a complete response lasting more than seven years.

Hepatocellular carcinoma (HCC), the most common type of liver cancer, presents a significant global health challenge due to its high incidence and associated mortality. Effective treatment options, especially for patients with severe liver dysfunction (Child-Pugh B stage), are limited. According to the American Cancer Society, liver cancer causes over 700,000 deaths annually worldwide. The prognosis for HCC is generally poor, and the market for its treatment is projected to reach $3.8 billion by 2027, according to Delveinsight.

The ongoing double-blind, placebo-controlled trial, named LIVERATION, plans to enroll 450 patients diagnosed with advanced HCC and underlying Child-Pugh B7 cirrhosis. These patients will be randomly assigned to receive either 25 mg of Namodenoson or a placebo twice daily, with a 2:1 ratio favoring Namodenoson as a second- or third-line treatment option. The trial's primary endpoint is overall survival, but other key outcomes, such as tumor response rates and median progression-free survival, will also be measured. Standard safety parameters will be evaluated, and an interim analysis will be performed by an Independent Data Monitoring Committee after half of the participants have been treated.

Namodenoson is an orally bioavailable small molecule that selectively binds to the A3 adenosine receptor (A3AR). This receptor is highly expressed in diseased cells but has low expression in normal cells, which contributes to the drug's favorable safety profile. Namodenoson has been tested in Phase II trials for HCC as a second-line treatment and for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Can-Fite BioPharma Ltd. is a clinical-stage drug development company focused on creating treatments for cancer, liver diseases, and inflammatory conditions. The company's leading drug candidate, Piclidenoson, has reported positive topline results in a Phase III trial for psoriasis and is set to commence another pivotal Phase III trial. Namodenoson, another key drug in Can-Fite's portfolio, is currently undergoing a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) and a Phase III trial for HCC. Plans are also in place for a Phase IIa study in pancreatic cancer. Namodenoson holds Orphan Drug Designation in both the U.S. and Europe and Fast Track Designation from the FDA as a second-line treatment for HCC. The drug has also shown potential in treating other cancers such as colon, prostate, and melanoma. Can-Fite's third drug candidate, CF602, has demonstrated efficacy in treating erectile dysfunction.

In summary, Can-Fite BioPharma continues to make significant strides in the development of Namodenoson for advanced liver cancer, supported by its Orphan Drug and Fast Track statuses, and is committed to expanding its clinical trials and exploring the drug's potential in treating other serious conditions.