RedHill Biopharma Announces YELIVA® (ABC294640) Abstract Presentation at the 2017 Cholangiocarcinoma Foundation Annual Conference
(Thomson Reuters ONE) -
* The abstract, to be presented at the upcoming 2017 Cholangiocarcinoma
Foundation Annual Conference, describes positive findings from non-clinical
studies and the Phase I clinical study with YELIVA(®) (ABC294640),
suggesting that YELIVA(®) may be an effective drug for the treatment of
cholangiocarcinoma
* A Phase I study with YELIVA(®) in patients with advanced solid tumors
successfully met its primary and secondary endpoints
* Of the three cholangiocarcinoma patients in the Phase I study, one patient
had a sustained partial response (Overall Survival (OS) = 20.3 months) and
the other two had stable disease (OS = 17.6 and 16.3 months)
* YELIVA(®) is a proprietary, first-in-class, orally-administered sphingosine
kinase-2 (SK2) selective inhibitor, with anti-cancer and anti-inflammatory
activities
* RedHill is pursuing several Phase I/II clinical studies with YELIVA(®) in
the U.S., targeting multiple oncology and inflammatory indications, some of
which are supported by National Cancer Institute (NCI) grants awarded to
Apogee Biotechnology and U.S. universities
TEL-AVIV, Israel, Jan. 06, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company primarily focused on the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for gastrointestinal and inflammatory diseases and cancer,
today announced the presentation of an abstract relating to YELIVA(®), the
Company's proprietary, first-in-class, orally-administered sphingosine kinase-2
(SK2) selective inhibitor, at the 2017 Cholangiocarcinoma Foundation Annual
Conference, on February 2, 2017, in Salt Lake City, UT.
The abstract, entitled 'Targeting Sphingosine Kinase-2 for the Treatment of
Cholangiocarcinoma (CCA)'(1), was authored by scientists from the Mayo Clinic,
Apogee Biotechnology Corp. (Apogee), the Medical University of South Carolina
(MUSC) and RedHill. It will be presented by one of its authors, Dr. Lewis R.
Roberts, M.B., Ch.B., Ph.D, a gastroenterologist and hepatologist at Mayo Clinic
and the External Co-Chair of The Cancer Genome Atlas (TCGA) Cholangiocarcinoma
Project of the National Cancer Institute (NCI).
The authors of the abstract assessed the effects of YELIVA(®) on
cholangiocarcinoma cells in culture and in patients in the Phase I clinical
study with YELIVA(®), concluding that the findings from these studies suggest
that YELIVA(®) may be an effective drug for the treatment of cholangiocarcinoma.
Cholangiocarcinoma (bile duct cancer) is a highly lethal malignancy for which
there is a need for more effective systemic treatments. Surgery with complete
resection remains the only curative therapy for cholangiocarcinoma, however only
a minority of patients are classified as having a resectable tumor at the time
of diagnosis(2).
RedHill announced in June 2016 that the final results from the Phase I study
with YELIVA(®) in patients with advanced solid tumors confirmed that the study,
conducted at MUSC Hollings Cancer Center, successfully met its primary and
secondary endpoints, demonstrating that the drug is well-tolerated and can be
safely administered to cancer patients at doses that provide circulating drug
levels that are predicted to have therapeutic activity.
Of the three patients with cholangiocarcinoma in the Phase I study, one subject
achieved a sustained partial response (Overall Survival (OS) = 20.3 months) and
the other two subjects had stable disease (OS = 17.6 and 16.3 months).
YELIVA(®) 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(®) blocks the
synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that
promotes cancer growth and pathological inflammation.
A Phase II study with YELIVA(®) for the treatment of advanced hepatocellular
carcinoma (HCC) was initiated at MUSC Hollings Cancer Center. The study is
supported by a $1.8 million grant from the NCI, awarded to MUSC, which is
intended to fund a broad range of studies on the feasibility of targeting
sphingolipid metabolism for the treatment of a variety of solid tumor cancers,
with additional support from RedHill.
A Phase Ib/II study with YELIVA(®) for the treatment of refractory or relapsed
multiple myeloma was initiated 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 I/II clinical study evaluating YELIVA(®) in patients with
refractory/relapsed diffuse large B-cell lymphoma was initiated in June 2015 at
the Louisiana State University Health Sciences Center in New Orleans and was
recently amended to address overall recruitment prospects. The study will now
also include Kaposi sarcoma patients. The study is supported by a grant from the
NCI awarded to Apogee, with additional support from RedHill.
A Phase Ib study to evaluate YELIVA(®) as a radioprotectant for prevention of
mucositis in head and neck cancer patients undergoing therapeutic radiotherapy
is planned to be initiated in the first half of 2017.
Additional Phase I/II studies with YELIVA(®) for other indications are in
various stages of preparation.
About YELIVA(®) (ABC294640):
YELIVA(®) (ABC294640) is a Phase II-stage, proprietary, first-in-class, orally-
administered, sphingosine kinase-2 (SK2) selective inhibitor with anti-cancer
and anti-inflammatory activities. RedHill is pursuing with YELIVA(®) multiple
clinical programs in oncology, inflammatory and gastrointestinal indications. By
inhibiting the SK2 enzyme, YELIVA(®) 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(®) 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. The Phase I study included the
first-ever longitudinal analysis of plasma S1P levels as a potential
pharmacodynamic (PD) biomarker for activity of a sphingolipid-targeted drug. The
administration of YELIVA(®) resulted in a rapid and pronounced decrease in S1P
levels, with several patients having prolonged stabilization of disease. The
development of YELIVA(®) 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 specialty
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 gastrointestinal and
inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with
Concordia for Donnatal(®), a prescription oral adjunctive drug used in the
treatment of IBS and acute enterocolitis. RedHill's clinical-stage pipeline
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 a completed proof-of-concept
Phase IIa study for multiple sclerosis; (iii) BEKINDA(®) (RHB-102) - a once-
daily oral pill formulation of ondansetron with an ongoing Phase III study for
acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D;
(iv) RHB-106 - an encapsulated bowel preparation licensed to Salix
Pharmaceuticals, Ltd.; (v) YELIVA(®) (ABC294640) - a Phase II-stage, orally-
administered, first-in-class SK2 selective inhibitor targeting multiple
oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase
II-stage first-in-class, orally-administered uPA inhibitor, targeting
gastrointestinal and other solid tumors and (vii) RIZAPORT(®) (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. More information about the Company is available
at: www.redhillbio.com.
(1) The abstract was authored by Lewis R. Roberts, Xiwei Ding, Melanie B.
Thomas, Carolyn D. Britten, Mark L. Levitt, Lynn W. Maines and Charles D. Smith
(2) Banales JM et al. Expert consensus document: Cholangiocarcinoma: current
knowledge and future perspectives consensus statement from the European Network
for the Study of Cholangiocarcinoma (ENS-CCA), Nat Rev Gastroenterol
Hepatol. 2016;13:261-280.
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.
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 Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: RedHill Biopharma Ltd. via GlobeNewswire
Datum: 06.01.2017 - 14:00 Uhr
Sprache: Deutsch
News-ID 516229
Anzahl Zeichen: 15396
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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