About 180 Million People Worldwide Are Infected with HCV; The size of the HCV Therapeutic Market is Currently Estimated to Be Above US$ 3 Billion
PETAH-TIKVA, Israel--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, reported today that a significant decrease in HCV viral load was noted in a patient with liver cancer treated daily, orally with CF102, within the framework of a Phase I/II clinical study in liver cancer (hepatocellular carcinoma, HCC) patients.
This Phase 1/2 study is enrolling patients with advanced or treatment-refractory HCC. Because one of the most important causes for HCC is chronic viral hepatitis, patients in this trial are tested at entry for infection with hepatitis C virus (HCV). Although not part of the primary trial objectives, those patients who are HCV-positive are retested periodically to gauge the effect of CF102 on HCV infection in this population.
In the first, lowest-dose, cohort of the trial, 1 patient was found to be HCV-positive with a circulating viral load of >106 IU/mL at entry. Over the course of treatment with CF102, the viral load fell by >1.4 log10 in the absence of any other intervention, providing a very strong indication for a significant effect of CF102 in suppressing viral replication in the liver.
According to Dr. Pnina Fishman, Can-Fite’s CEO, “these results are especially encouraging for 2 reasons. First, they validate our extensive pre-clinical data indicating CF102’s effectiveness in treating liver disease in general, and hepatitis C viral infection in particular. Second, this result is encouraging for Can-Fite’s other ongoing CF102 trial, a Phase 1/2 study in patients with HCV infection. We are optimistic that CF102 can become part of the treatment arsenal for the millions of people worldwide who suffer from hepatitis C.”
HCV is predominantly transmitted through body fluids and less frequently by sexual intercourse and no vaccines are currently available. About 50% to 85% of HCV infected patients develop a chronic form of the disease, of whom 25% to 76% develop active chronic disease and cirrhosis, which is the leading cause for the need for liver transplantation in Europe and the US and greatly increases the risk of liver cancer. Patients are currently offered drug therapy that generally consists of oral Ribavirin in combination with interferon injections. These drugs have severe adverse events and most patients rapidly become refractory to them. The market size for drugs to treat HCV infection is more than $3 Billion and is estimated to grow to around $8.3 Billion by 2012.
The Company previously reported that preclinical studies have suggested that the drug is active against HCV via inhibition of NS5, RNA dependent RNA polymerase. CF102 was also found to trigger programmed cell death (apoptosis) of liver cancer cells. The Company recently announced the successful completion of a Phase I clinical study with CF102 under an IND in the US, showing a safety profile and a linear pharmacokinetic behavior of the drug.
CAN-FITE BIOPHARMA LTD is a public company traded on the Tel Aviv Stock Exchange. The Company, which commenced business activity in 2000, was founded by Prof. Pnina Fishman, an investigator from Rabin Medical Center, and patent attorney Dr. Ilan Cohn, a senior associate at Reinhold Cohn Patent Attorneys. Prof. Pnina Fishman serves as the CEO of Can-Fite. The Company was founded on the basis of scientific findings made by Prof. Pnina Fishman and focuses on the development of molecule-based drugs that bind to receptors on and inhibit the development of cancer or inflammatory cells.
Can-Fite's development pipeline currently has two drugs, CF101 and CF102. The company is simultaneously conducting clinical trials with the two drugs for various indications. CF101 is being studied for the treatment of inflammatory and Ophthalmic diseases and CF102 is studied for the treatment of Liver Diseases.
KEYWORDS: United States North America Middle East Israel
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Oncology Pharmaceutical