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

  • The $1.8 million U.S. National Cancer Institute (NCI) grant, awarded to the Medical University of South Carolina (MUSC), is intended to support a research program covering a variety of solid tumor cancers, including a Phase II study with YELIVA(TM) (ABC294640) for the treatment of advanced hepatocellular carcinoma, planned to be initiated in Q3/2016 at MUSC and collaborating institutions
  • RedHill previously announced positive top-line results from a Phase I study with YELIVA(TM) in patients with advanced solid tumors; A Phase I/II study with YELIVA(TM) was initiated in the U.S. in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL)
  • A Phase I/II study with YELIVA(TM) for refractory or relapsed multiple myeloma is planned to be initiated in Q2/2016 and is supported by a $2 million NCI grant awarded to Apogee Biotechnology Corp. (Apogee); A Phase II study to evaluate YELIVA(TM) as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy is planned to be initiated in H2/2016
  • YELIVA(TM) is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications
  • The development of YELIVA(TM) was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee, including from the NCI, the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), the Department of Defense and the FDA Office of Orphan Products Development

RedHill Biopharma Ltd. RDHL, -2.21% (tase:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, today announced that the U.S. National Cancer Institute ("NCI") has awarded the Medical University of South Carolina ("MUSC") a $1.8 million grant to support a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers. One component of the studies includes a planned Phase II study with YELIVA [(TM)] (ABC294640) for the treatment of advanced hepatocellular carcinoma ("HCC"), the most common primary malignant cancer of the liver [1] . YELIVA [(TM) ] is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor.

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 [(R)] ). 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 atHadassah 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 worldwide [2] . 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...