RedHill Biopharma Announces National Cancer Institute Grant Supporting YELIVA(TM) Phase II Hepatocellular Carcinoma Study
(Thomson Reuters ONE) -
* 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
Pharmaceuticals, Ltd.; (v) YELIVA(TM) (ABC294640) - a Phase II-stage, orally-
administered, first-in-class SK2 selective inhibitor targeting multiple
oncology, inflammatory and gastrointestinal indications with a Phase I/II study
initiated for refractory/relapsed diffuse large B-cell lymphoma (DLBCL);
(vi) MESUPRON® - a Phase II-stage first-in-class uPA inhibitor, administered by
oral capsule, targeting gastrointestinal and other solid tumors; (vii) RP101 -
currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage
first-in-class Hsp27 inhibitor, administered by oral tablet, targeting
pancreatic and other gastrointestinal cancers; (viii) RIZAPORT(TM) (RHB-103) -
an oral thin film formulation of rizatriptan for acute migraines, with a U.S.
NDA currently under discussion with the FDA and marketing authorization received
in Germany in October 2015; and (ix) RHB-101 - a once-daily oral pill
formulation of the cardio drug carvedilol.
This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Such statements may be
preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes,"
"potential" or similar words. Forward-looking statements are based on certain
assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company's control, and cannot be
predicted or quantified and consequently, actual results may differ materially
from those expressed or implied by such forward-looking statements. Such risks
and uncertainties include, without limitation, risks and uncertainties
associated with (i) the initiation, timing, progress and results of the
Company's research, manufacturing, preclinical studies, clinical trials, and
other therapeutic candidate development efforts; (ii) the Company's ability to
advance its therapeutic candidates into clinical trials or to successfully
complete its preclinical studies or clinical trials; (iii) the extent and number
of additional studies that the Company may be required to conduct and the
Company's receipt of regulatory approvals for its therapeutic candidates, and
the timing of other regulatory filings, approvals and feedback; (iv) the
manufacturing, clinical development, commercialization, and market acceptance of
the Company's therapeutic candidates; (v) the Company's ability to establish and
maintain corporate collaborations; (vi) the Company's ability to acquire
products approved for marketing in the U.S. that achieve commercial success and
build its own marketing and commercialization capabilities; (vii) the
interpretation of the properties and characteristics of the Company's
therapeutic candidates and of the results obtained with its therapeutic
candidates in research, preclinical studies or clinical trials; (viii) the
implementation of the Company's business model, strategic plans for its business
and therapeutic candidates; (ix) the scope of protection the Company is able to
establish and maintain for intellectual property rights covering its therapeutic
candidates and its ability to operate its business without infringing the
intellectual property rights of others; (x) parties from whom the Company
licenses its intellectual property defaulting in their obligations to the
Company; (xi) estimates of the Company's expenses, future revenues capital
requirements and the Company's needs for additional financing; (xii) competitive
companies and technologies within the Company's industry; and (xiii) the impact
of the political and security situation in Israel on the Company's business.
More detailed information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the Company's
filings with the Securities and Exchange Commission (SEC), including the
Company's Annual Report on Form 20-F filed with the SEC on February 25, 2016.
All forward-looking statements included in this Press Release are made only as
of the date of this Press Release. We assume no obligation to update any written
or oral forward-looking statement unless required by law.
1 Gomma AI et al., Hepatocellular carcinoma: epidemiology, risk factors and
pathogenesis, World J Gastroenterol, 2008 Jul 21; 14(27): 4300-8.
2 Forner A et al., 'Hepatocellular Carcinoma', Lancet, 2012 Mar
31; 379(9822): 1245-55.
3 World Health Organization International Agency for Research on Cancer,
GLOBOCAN 2012: Estimated Cancer Incidence , Mortality and Prevalence Worldwide
in 2012.
4 Datamonitor
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi(at)redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus(at)troutgroup.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: RedHill Biopharma Ltd. via GlobeNewswire
[HUG#2009948]
Datum: 04.05.2016 - 14:21 Uhr
Sprache: Deutsch
News-ID 468696
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contact information:
Town:
Tel-Aviv
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Business News
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