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2016-12-19

RedHill Biopharma Ltd. : RedHill Biopharma Announces First Patient Dosed in Phase Ib/II Study with YELIVA® for Multiple Myeloma

* The first patients have been screened and a first patient has been dosed in
the open-label, dose escalation Phase Ib/II study with YELIVA® (ABC294640)
for multiple myeloma
* The Phase Ib/II clinical study is intended to evaluate the safety and
efficacy of YELIVA® in up to 77 patients with refractory or relapsed
multiple myeloma who have previously been treated with proteasome
inhibitors and immunomodulatory drugs
* The study is supported by a $2 million grant from the National Cancer
Institute (NCI) awarded to Apogee Biotechnology Corp., with additional
support from RedHill
* 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 and Phase II clinical
studies with YELIVA ® in the U.S., targeting multiple oncology and
inflammatory indications
* Worldwide sales of multiple myeloma therapies are estimated to exceed $12
billion in 2016

TEL-AVIV, Israel, Dec. 19, 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
gastrointestinal and inflammatory diseases and cancer, today announced that
the first patients have been screened and a first patient has been dosed in
the Phase Ib/II clinical study evaluating YELIVA® (ABC294640) in patients
with refractory or relapsed multiple myeloma.

The open-label, dose escalation Phase Ib/II study is being conducted at Duke
University Medical Center and is expected to enroll up to 77 patients with
refractory or relapsed multiple myeloma who have previously been treated with
proteasome inhibitors and immunomodulatory drugs.

Dr. Yubin Kang, MD, Associate Professor in the Division of Hematologic
Malignancies and Cellular Therapy in the Department of Medicine at Duke
University School of Medicine, is the lead investigator for the study.

The study is supported by a $2 million grant from the National Cancer
Institute (NCI) Small Business Innovation Research Program (SBIR) awarded to
Apogee Biotechnology Corp. (Apogee), in conjunction with Duke University,
with additional support from RedHill.

YELIVA® is a proprietary, first-in-class, orally-administered sphingosine
kinase-2 (SK2) selective inhibitor, with anti-cancer and anti-inflammatory
activities. 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.

RedHill is pursuing and evaluating multiple clinical programs in oncology,
inflammatory and gastrointestinal indications with YELIVA®, as well as
potential collaboration opportunities with larger pharmaceutical companies to
evaluate YELIVA® as an add-on therapy to existing oncology treatments.

Results from a Phase I study with YELIVA® in patients with advanced solid
tumors confirmed that the study, conducted at the Medical University of South
Carolina Hollings Cancer Center (MUSC), 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.

A Phase II study with YELIVA® for the treatment of advanced hepatocellular
carcinoma (HCC) was initiated at MUSC Hollings Cancer Center, following
ethics approval and successful submission to the U.S. FDA. 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 I/II clinical study evaluating YELIVA® in patients with
refractory/relapsed diffuse large B-cell lymphoma was initiated at the
Louisiana State University Health Sciences Center in New Orleans in June 2015
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.

The ongoing studies with YELIVA® (ABC294640) 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 Multiple Myeloma:
Multiple myeloma is a malignant plasma cell disorder which is usually not
curable1. Symptomatic multiple myeloma is characterized by a clonal
proliferation of plasma cells preceding clinical findings that include bone
lesions, fractures, anemia, renal failure and hypercalcemia2. Approximately
30,000 new cases of multiple myeloma are expected to be diagnosed in the U.S.
in 2016, accounting for 1.8% of all cancers. The 5-year survival rate of
myeloma is estimated at 48.5% and approximately 95,000 people are living with
myeloma in the United States3. The risk of multiple myeloma increases as
people age. Most patients diagnosed with this cancer are at least 65 years
old4, making treatment with the most effective therapies problematic. The
worldwide sales of multiple myeloma therapies are estimated to exceed $12
billion in 20165.

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 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's 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 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.

1 Ludwig, H., et al.
Survival and years of life lost in different age cohorts of patients with
multiple myeloma. J Clin Oncol
28, 1599-1605 (2010).

2 Kyle, R.A.&Rajkumar, S.V. Multiple myeloma. Blood
111, 2962-2972 (2008).

3 'Surveillance, Epidemiology, and End Results Program', Myeloma

4 American Cancer Society, Multiple Myeloma (January 2016)

5 GlobalData Pharma eTrack, multiple myeloma estimated market size (September
2016)

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 re...

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