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2016-05-04

RedHill Biopharma Ltd. : 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

TEL-AVIV, Israel, May 04, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (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 liver1. 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®). 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.

RedHill previously announced positive top-line results from a Phase I study
with YELIVA(TM) in patients with advanced solid tumors, the majority of which
were gastrointestinal cancer patients, including pancreatic, colorectal and
cholangiocarcinoma cancers. Top-line results demonstrated that YELIVA(TM) can
be safely administered to cancer patients at doses that provide circulating
drug levels that are predicted to have therapeutic activity, based on levels
required in preclinical models. Final results are expected in the coming
weeks. The Phase I study included the first-ever longitudinal analysis of
plasma sphingosine-1-phosphate (S1P) levels as a potential pharmacodynamic
biomarker for activity of a sphingolipid-targeted drug. The administration of
YELIVA(TM) resulted in a rapid and pronounced decrease in S1P levels over the
first 12 hours, with return to baseline at 24 hours, consistent with
clearance of the drug, with several patients having prolonged stabilization
of disease.

A Phase I/II clinical study was initiated in June 2015 in the U.S. evaluating
YELIVA(TM) in patients with refractory/relapsed diffuse large B-cell lymphoma
(DLBCL), including in patients with HIV-related DLBCL. The study is being
conducted at the Louisiana State University Health Sciences Center (LSUHSC)
in New Orleans and is supported by a grant awarded to Apogee from the NCI
Small Business Technology Transfer (STTR) program, as well as additional
support from RedHill.

A Phase I/II study with YELIVA(TM) for the treatment of refractory or relapsed
multiple myeloma is planned to be initiated in the second quarter of 2016.
The study will be conducted at Duke University Medical Center. The study is
supported by a $2 million grant from the NCI Small Business Innovation
Research Program (SBIR) awarded to Apogee in conjunction with Duke
University, with additional support from RedHill.

A Phase II clinical study to evaluate YELIVA(TM) as a radioprotectant to
prevent mucositis in cancer patients undergoing therapeutic radiotherapy is
planned to be initiated in the U.S. during the second half of 2016, subject
to regulatory and other conditions.

The Phase I/II clinical studies in patients with DLBCL and multiple myeloma,
as well as the Phase I clinical study in cancer patients with advanced solid
tumors are registered on www.ClinicalTrials.gov, a web-based service by the
U.S. National Institute of Health which provides public access to information
on publicly and privately supported clinical studies.

About YELIVA(TM) (ABC294640):

YELIVA(TM) (ABC294640) is a Phase II-stage, 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. By inhibiting the SK2 enzyme,
YELIVA(TM) blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid
signaling molecule that promotes cancer growth and pathological inflammation.
SK2 is an innovative molecular target for anticancer therapy because of its
critical role in catalyzing the formation of S1P, which is known to regulate
cell proliferation and activation of inflammatory pathways. YELIVA(TM) was
originally developed by U.S.-based Apogee Biotechnology Corp. and completed
multiple successful pre-clinical studies in oncology, inflammation, GI and
radioprotection models, as well as the ABC-101 Phase I clinical study in
cancer patients with advanced solid tumors. A Phase I/II clinical study
evaluating YELIVA(TM) in patients with refractory/relapsed diffuse large
B-cell lymphoma (DLBCL) has been initiated in the U.S. 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 Biotechnology Corp.,
including the U.S. National Cancer Institute, the U.S. Department of Health
and Human Services' Biomedical Advanced Research and Development Authority
(BARDA), the U.S. Department of Defense and the FDA Office of Orphan Products
Development.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a biopharmaceutical
company headquartered in Israel, primarily focused on the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for the treatment of inflammatory and gastrointestinal
diseases, including cancer. RedHill's current pipeline of proprietary
products includes: (i) RHB-105
-
an oral combination therapy for the treatment of Helicobacter pylori
infection with successful results from a first Phase III study; (ii)RHB-104
-
an oral combination therapy for the treatment of Crohn's disease with an
ongoing first Phase III study and an ongoing proof-of-concept Phase IIa study
for multiple sclerosis; (iii) BEKINDA(TM)
(RHB-102)
-
a once-daily oral pill formulation of ondansetron with an ongoing Phase III
study in the U.S. for acute gastroenteritis and gastritis and a Phase II
study for IBS-D; (iv) RHB-106
-
an encapsulated bowel preparation licensed to Salix Pharmaceut...

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