DGAP-News: RedHill Biopharma Ltd. / Key word(s): Miscellaneous
RedHill Biopharma Ltd.: RedHill Biopharma Announces Collaboration with
Germany's Fraunhofer Institute for Oncology Drug
08.02.2016 / 14:09
The issuer is solely responsible for the content of this announcement.
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Press Release
RedHill Biopharma Announces Collaboration with Germany's Fraunhofer
Institute for Oncology Drug RP101
TEL-AVIV, Israel, February 8, 2016 RedHill Biopharma Ltd. (NASDAQ/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/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(R) - 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.
<pre>
Company contact: IR contact (U.S.):
Adi Frish Marcy Nanus
Senior VP Business Development & Senior Vice President
The Trout Group
Licensing +1-646-378-2927
RedHill Biopharma Mnanus@troutgroup.com
+972-54-6543-112
adi@redhillbio.com
</pre>
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service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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435485 08.02.2016
DGAP-News: RedHill Biopharma Ltd.: RedHill Biopharma Announces Collaboration with Germany's Fraunhofer Institute for Oncology Drug
| Source: EQS Group AG