Can-Fite: 75 Experts from Europe, US, and Israel Joined Conference to Accelerate Phase 3 Liver Cancer Study Enrollment

Can-Fite BioPharma Ltd., a biotechnology firm focusing on proprietary small molecule drugs for oncological and inflammatory diseases, recently convened a conference in Ramat Gan, Israel, to expedite patient enrollment in its pivotal Phase 3 study for advanced liver cancer. The gathering included 75 oncologists and coordinators involved in the study. During the event, participants were briefed on the drug's chemical and biological properties, the study protocol, and procedures. Dr. Lencioni, an esteemed radiologist specializing in liver tumors from Pisa University School of Medicine in Italy, educated attendees on measuring tumor lesion sizes before and after treatment with namodenoson. These measurements are crucial for determining progression-free survival (PFS) and the objective response rate (ORR) to the drug, which are key objectives of the study. U.S. experts also provided training on the electronic data entry system to be used during the trial.

Dr. Pnina Fishman, Chief Scientific Officer and Executive Chairperson of Can-Fite, expressed satisfaction with the conference's outcome, noting the enthusiasm of the participants for the drug's potential. The company has secured agreements from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the pivotal Phase 3 clinical trial, which is currently enrolling patients in Israel, Europe, and the U.S. An interim analysis is planned by an Independent Data Monitoring Committee (IDMC) once 50% of the patients are enrolled. Namodenoson will be assessed as a second or third-line treatment for CPB7 liver cancer patients who have not responded to other approved therapies. 

Namodenoson holds Orphan Drug status with both the FDA and EMA and has received Fast Track status from the FDA for hepatocellular carcinoma (HCC). Additionally, a compassionate use program for the drug is ongoing in Israel and Romania. Liver cancer is responsible for over 700,000 deaths annually worldwide, with HCC being particularly aggressive and having poor survival rates. The market for HCC treatments is projected to reach $6.1 billion by 2027, according to Delveinsight.

About Namodenoson, it is a small molecule drug that binds selectively to the A3 adenosine receptor (A3AR). Phase II trials have evaluated Namodenoson for two indications: as a second-line treatment for hepatocellular carcinoma and for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is predominantly expressed in diseased cells, which contributes to the drug's excellent safety profile.

Can-Fite BioPharma Ltd. is an advanced clinical-stage drug development company targeting large markets in cancer, liver, and inflammatory diseases. The company’s lead drug candidate, Piclidenoson, recently concluded a Phase III trial for psoriasis and is set to begin a pivotal Phase III study. Another key drug, Namodenoson, is undergoing a Phase IIb trial for steatotic liver disease (SLD) and a Phase III pivotal trial for HCC, with plans for a Phase IIa study in pancreatic cancer. Namodenoson has shown potential to treat other cancers, including colon, prostate, and melanoma. The company’s third drug candidate, CF602, has demonstrated efficacy in treating erectile dysfunction. Can-Fite’s drugs have proven safe in clinical studies involving over 1,600 patients to date. 

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!