RedHill Biopharma Announces National Cancer Institute Grant Supporting YELIVA(TM) Phase II Hepatocellular Carcinoma Study - Seite 2

The Phase II study, planned to be initiated in the third quarter of 2016, will be conducted at MUSC and additional clinical sites and is intended to evaluate the efficacy and safety of YELIVA(TM) as a second-line monotherapy in patients with advanced HCC. The study is planned to enroll up to 39 patients who have experienced tumor progression following treatment with first-line single-agent sorafenib (Nexavar®). Carolyn D. Britten, MD, Director of Hematology/Oncology Division in the Department of Medicine at MUSC and Associate Director for Clinical Investigations at the MUSC Hollings Cancer Center, will act as Principal Investigator for the study.

Prof. Ran Oren, MD, Head of the Institute of Gastroenterology and Liver Diseases at Hadassah University Hospital, Ein Kerem, and a Member of RedHill's Advisory Board, Said: "Hepatocellular carcinoma (HCC) is one of the most common malignancies worldwide, with one of the highest mortality rates among cancers. It arises most frequently in patients suffering from chronic liver disease and poses an increasing problem in the Western world due to hepatitis B and hepatitis C virus infections, alcoholic cirrhosis and non-alcoholic steatohepatitis resulting from high obesity rates. Curative treatments, such as hepatic resection and liver transplant, are available only to patients diagnosed with early HCC. While these treatments offer good prognosis, they are extremely limited in their application. Over two-thirds of HCC patients in the developed world are diagnosed at advance stages of the disease, emphasizing the strong need for novel therapeutic treatments for both early and late stage HCC."

The NCI grant covers a five-year period. The Phase II HCC study will be further supported by additional funding from RedHill, which acquired the exclusive worldwide rights to YELIVA(TM) from Apogee Biotechnology Corp. ("Apogee").

HCC is the most common primary malignant cancer of the liver. It is the sixth most prevalent cancer and the third most frequent cause of cancer-related death worldwide2. Annual worldwide incidence of liver cancer was estimated to have reached 782,000 cases in 2012, with mortality of 746,000; the corresponding U.S. numbers are 30,000 and 24,000, respectively3. Most patients with HCC suffer from liver cirrhosis, which develops following long periods of chronic liver disease. The majority of HCC cases are associated with hepatitis B and hepatitis C virus infections. Additional causes for HCC include heavy alcohol consumption, obesity, diabetes, tobacco smoking, metabolic syndrome leading to fatty liver and hemachromatosis. The prognosis of patients with HCC is affected by the disease stage at diagnosis and by the underlying liver function. Few treatment options exist for patients diagnosed at an advanced stage, representing the majority of HCC patients. Sorafenib (Nexavar®) is a targeted drug approved for the treatment of HCC in patients who are not candidates for surgery and do not have severe cirrhosis. The worldwide and U.S. markets for the treatment of HCC are estimated to reach approximately $895 million and $471 million in 2017, respectively4.