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2016-02-08

RedHill Biopharma Ltd. : RedHill Biopharma Announces Collaboration With Germany's Fraunhofer Institute for Oncology Drug RP101

TEL-AVIV, Israel, Feb. 08, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli
biopharmaceutical company primarily focused on the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for inflammatory and gastrointestinal diseases,
including cancer, today announced a research collaboration with Leipzig-based
Fraunhofer Institute for Cell Therapy and Immunology (IZI), a research unit
of the Fraunhofer Society, one of the largest and most prominent applied
research organizations in the world, for the evaluation of RedHill's Phase
II-stage oncology drug candidate, RP101.

The research collaboration tests RP101 in pre-clinical oncology models,
including pancreatic cancer, in combination with standard-of-care
chemotherapies to support existing Phase I and Phase II clinical data. RP101
is a proprietary, first-in-class, orally-administered, heat shock protein 27
(Hsp27) inhibitor intended to prevent the induction of resistance to
chemotherapy (chemoresistance), thus maintaining sensitivity of the tumor to
chemotherapy and potentially enhancing patient survival. RP101 has completed
several clinical studies, including a Phase II study in pancreatic cancer and
has been granted Orphan Drug Designation for the adjunct treatment of
pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA).

As part of the collaboration, Fraunhofer IZI is conducting real-time
monitoring of tumor engraftment, tumoricidal efficacy, and response to
treatment with RP101 in combination with standard-of-care chemotherapies.
Results from the studies are expected during the first half of 2016. The
preclinical program is intended to support the existing Phase I and Phase II
clinical data with RP101 and to assess the drug's clinical development path.

In August 2014, RedHill entered into an exclusive option agreement with
RESprotect GmbH, a privately-held Germany-based biotech company, under which
RedHill obtained the option to acquire the worldwide exclusive rights to
RP101 for all indications, other than for the pancreatic cancer indication in
South Korea. RedHill announced in July 2015 that it had extended the term of
the exclusive option agreement for an additional year.

About RP101:

RP101 is a nucleoside analogue found by Prof. Rudolf Fahrig at the Fraunhofer
Institute for Toxicology and Experimental Medicine (ITEM) in Hannover,
Germany, to inhibit development of chemoresistance in various cancer models.
It is an orally-administered, patent-protected small molecule which binds to
heat shock protein 27 (Hsp27) and inhibits its anti-apoptotic effects. Hsp27
is a chaperone protein which is found in abnormally high levels in cancer
cells. The overexpression of Hsp27, which results in anti-apoptotic effects,
has been linked to tumor resistance to cytotoxic drugs and the development of
metastasis. By inhibiting Hsp27, RP101 may prevent the induction of
resistance to chemotherapy (chemoresistance) and maintain sensitivity of
tumors to chemotherapy, thus potentially enhancing patient survival. RP101
has been studied in several Phase I and Phase II clinical studies with a
total of 249 subjects treated, including a Phase II study in pancreatic
cancer. RP101 has been granted Orphan Drug Designation for the adjunct
treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency (EMA).

About RedHill Biopharma Ltd.:

RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is an emerging Israeli
biopharmaceutical company 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 top-line 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; (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; (iv) RHB-106

-

an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.;
(v) YELIVA
(TM)

(ABC294640)

-

an 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.

About Fraunhofer IZI:

The Fraunhofer Institute for Cell Therapy and Immunology IZI investigates and
develops specific problem solutions at the interfaces of medicine, life
sciences and engineering. The Institute practices contract research for
biotechnological, pharmaceutical and medical-technological companies,
hospitals, diagnostic laboratories and research facilities. The Institute's
core competencies are located in the field of Regenerative Medicine, in
particular in the indication areas of oncology, ischemia and autoimmune,
inflammatory and infectious diseases. The Institute is clinically oriented
and conducts quality checks and the GMP-compliant manufacture of
investigational medicinal products. Moreover, the Institute provides support
in obtaining manufacturing authorizations and approvals.
www.izi.fraunhofer.de

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 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;
(vii) the implementation of the Company's business model, strategic plans for
its business and therapeutic candidates; (viii) 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; (ix) parties
from whom the Company licenses its intellectual property defaulting in their
obligations to the Company; (x) estimates of the Company's expenses, future
revenues capital requirements and the Company's needs for additional
financing; (xi) competitive companies and technologies within the Company's
industry; and (xii) 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 26, 2015. 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@redhillbio.com

IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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

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