Can-Fite Reports 9-Year Complete Response in Advanced Liver Cancer Patient as Phase III Trial Enrolls

Can-Fite BioPharma查看公司主页 Ltd. announced that a patient with advanced hepatocellular carcinoma (HCC) treated with its investigational drug Namodenoson查看药品详情 has achieved an unprecedented 9-year overall survival with complete response to treatment. The milestone comes as the biotechnology company actively enrolls patients in a pivotal Phase III clinical study for the oral small molecule drug.

The patient, originally enrolled in Can-Fite's completed Phase II study, continues to receive Namodenoson查看药品详情 through a compassionate use program and remains cancer-free nine years following treatment initiation. The patient meets the definition of a complete responder based on the disappearance of ascites, normal liver function, and good quality of life.

Phase III Trial Advances with Regulatory Support

Can-Fite is currently enrolling patients in Israel, Europe, and the United States for a pivotal Phase III clinical study evaluating Namodenoson查看药品详情 in patients with advanced HCC as a second or third-line treatment. The study protocol has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Namodenoson查看药品详情 has secured Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for HCC treatment. Compassionate use programs are ongoing in Israel and Romania, providing expanded access to the investigational therapy.

"With Namodenoson查看药品详情's potent anti-cancer activity, along with its excellent tolerability, we aim to deliver longer survival for patients and hope to see outcomes that mirror the exceptional 9 year response achieved by the long-treated patient from our prior Phase II study," stated Prof. Pnina Fishman, Can-Fite CSO & Chairperson. "Namodenoson's highly selective action against tumor cells, combined with its protection of healthy liver tissue, has the potential to make our Phase III trial especially promising."

Addressing Critical Unmet Need in Liver Cancer

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC represents an aggressive malignancy with poor survival rates, creating significant unmet medical need for effective treatments. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries.

Mechanism and Broader Development Pipeline

Namodenoson查看药品详情 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). The A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

Beyond the Phase III HCC trial, Namodenoson查看药品详情 is being evaluated in a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH) and in a Phase IIa study in pancreatic cancer. The drug has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma.

Can-Fite's drug candidates have demonstrated an excellent safety profile with experience in over 1,600 patients in clinical studies to date. The company's lead drug candidate, Piclidenoson查看药品详情, reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial, while CF602查看药品详情, the company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction.