Can-Fite's CF102 has FDA's Orphan Drug Designation for the treatment of advanced hepatocellular carcinoma
PETACH TIKVA, Israel, June 2, 2014 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that the U.S. FDA has agreed with the Company's study protocol for its Phase II clinical trial of CF102 for the treatment of advanced liver cancer. The FDA has granted Can-Fite Orphan Drug designation for CF102 in this indication.
The planned Phase II study will be conducted in the U.S., Europe, and Israel with 78 subjects who will be dosed with CF102 as a second-line treatment of advanced hepatocellular carcinoma (HCC) with Child-Pugh Class B cirrhosis in patients who have failed sorafenib, an FDA approved drug for the treatment of HCC. The study will investigate the efficacy and safety of CF102 as compared to placebo.
Tufts University School of Medicine is the study's U.S. clinical site. Dr. Keith Stuart, MD, will serve as Principal Investigator for the study at Tufts. He is Chairman, Department of Hematology at Lahey Clinic and Oncology Professor of Medicine, Tufts University School of Medicine.
Data from Can-Fite's completed Phase I/II study demonstrated an excellent safety profile, lack of hepatotoxicity, prolonged survival time as compared to placebo, regression of skin tumor metastases, and a stabilization of the disease in 22% of patients.
HCC, the most common form of liver cancer, is the 4th most common cancer in the world, according to information published by the National Cancer Institute. In the United States, the American Cancer Society estimates there will be 33,190 new cases diagnosed in 2014 and 23,000 deaths due to the disease. As reported by the American Cancer Society, globally each year 700,000 people are diagnosed with HCC each year and 600,000 people die of this cancer. The relative 5-year survival rate from liver cancer is about 15% in the U.S. According to Global Industry Analysts, the global liver cancer drug market is expected to exceed $2 billion by 2015.
"Advanced liver cancer is resistant to chemotherapy and the only approved drug on the market is Nexavar (sorafenib). We will treat patients who have no other treatment options," stated Can-Fite CEO Dr. Pnina Fishman.
CF102 is a small orally bioavailable drug which binds with high affinity and selectivity to the A3 adenosine receptor. The latter is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In our pre-clinical and clinical studies, CF102 induces a robust anti-tumor effect via de-regulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) 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 and inflammatory diseases. The Company's CF101 is in Phase II/III trials for the treatment of psoriasis and the Company is preparing for a Phase III CF101 trial for rheumatoid arthritis. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com
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SOURCE Can-Fite BioPharma Ltd.