RedHill Biopharma Announces Positive Final Results with Primary and Secondary Endpoints Met in Phase 1 Study with YELIVA(TM) in Advanced Solid Tumors
(Thomson Reuters ONE) -
* Final results from the Phase I study with YELIVA((TM)) (ABC294640) in
patients with advanced solid tumors confirmed that the study, conducted at
the Medical University of South Carolina (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
* Twenty-one patients with advanced solid tumors were treated with
YELIVA((TM)) in the study, the majority of which were gastrointestinal
cancer patients, including pancreatic, colorectal and cholangiocarcinoma
cancers
* The study included the first-ever longitudinal analyses of plasma
sphingosine 1-phosphate (S1P) levels as a potential pharmacodynamic
biomarker for activity of a sphingolipid-targeted drug; administration of
YELIVA((TM)) resulted in a rapid and pronounced decrease in levels of S1P
with several patients having prolonged stabilization of disease
* The Phase I study was supported by grants from the U.S. National Cancer
Institute (NCI) awarded to MUSC Hollings Cancer Center, an NCI-Designated
Cancer Center, and from the U.S. FDA Office of Orphan Products Development
(OOPD) awarded to Apogee Biotechnology Corp. (Apogee)
* A Phase I/II study with YELIVA((TM) )for refractory or relapsed multiple
myeloma is planned to be initiated in the coming weeks and is supported by a
$2 million NCI grant awarded to Apogee in conjunction with Duke University;
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; a Phase II study with YELIVA((TM) )for the
treatment of advanced hepatocellular carcinoma is planned to be initiated in
Q3/2016 and is also supported by an NCI grant awarded to MUSC
* YELIVA((TM)) 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
TEL-AVIV, Israel, June 21, 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 positive final results
from the Phase I study with YELIVA((TM)) (ABC294640) in advanced solid tumors.
YELIVA((TM)) 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.
"We are very pleased with the results of the Phase I study with YELIVA((TM) )in
advanced solid tumors. The study demonstrated the safety and tolerability of
this novel drug candidate, as well as its potential efficacy, with several
patients in the study who experienced stable disease with progression-free
survival for significant terms, despite the advanced nature of their
cancers," said Terry Plasse, MD, RedHill's Medical Director. "We are excited
about the therapeutic potential of YELIVA((TM) )for multiple oncology,
inflammatory and gastrointestinal indications, and look forward to initiation of
additional Phase II studies by the end of this year. Given YELIVA((TM))'s unique
mechanism of action, we also strongly believe that it could provide an added
benefit to cancer patients in combination with several of the leading oncology
drugs currently available, and we are currently exploring potential
collaboration opportunities to evaluate YELIVA((TM)) as an add-on therapy."
The Phase I Clinical Study Report (CSR) confirms the positive top-line results
previously announced by the Company. The final 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. The study included the first-ever
longitudinal analyses of plasma S1P levels as a potential pharmacodynamic
biomarker for activity of a sphingolipid-targeted drug. 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, which is consistent with
clearance of the drug. In addition, one patient had a prolonged partial
remission and several patients had prolonged stabilization of disease.
The primary objectives of the study were to identify the maximum tolerated dose
(MTD), the dose limiting toxicities (DLTs) and to evaluate the safety of
YELIVA((TM)). The primary objectives were all met and the drug was found to be
safe and well tolerated, with grade 1-2 fatigue and nausea being the most common
side effects. Several patients experienced mild neuropsychiatric symptoms, such
as anxiety and mood changes. These were resolved quickly upon discontinuation of
study medication. All treatment-related adverse events were rapidly reversible
upon dose reduction or study drug removal.
The secondary objectives of the study, to determine the pharmacokinetic (PK) and
pharmacodynamic (PD) properties of YELIVA((TM)) and to assess its antitumor
activity, were also met.
Among the 16 subjects that were assessable for response by RECIST 1.1 criteria
(Response Evaluation Criteria in Solid Tumors), one subject had a partial
response with a progression-free survival of 16.9 months, and six subjects had
stable disease with a progression-free survival of between 3.5 and 17.6 months.
Of the three patients with cholangiocarcinoma, one had a partial response and
the other two had stable disease, one for over a year. YELIVA((TM)) was well
tolerated over a prolonged period at doses inducing the expected pharmacodynamic
effects.
An important differentiating point between YELIVA((TM)) and the other two
compounds which act on the S1P receptor (GILENYA(®) (fingolimod hydrochloride),
approved for the treatment of multiple sclerosis, and ozanimod hydrochloride,
currently under development for ulcerative colitis, Crohn's disease and multiple
sclerosis), is that YELIVA((TM)) causes only modest decreases in lymphocyte
count. A decrease in lymphocytes may make patients susceptible to certain
infections.
Preliminary positive data from the Phase I study was presented by Apogee
Biotechnology Corp. (Apogee) at the November 2013 Molecular Targets and Cancer
Therapeutics meeting.
The Phase I study was conducted at the Medical University of South Carolina
(MUSC) Hollings Cancer Center, an NCI-Designated Cancer Center, and was
supported by grants from the U.S. National Cancer Institute (NCI) awarded to
MUSC, and from the U.S. FDA Office of Orphan Products Development (OOPD) awarded
to Apogee. The study was led by Principal Investigators Melanie Thomas, MD and
Carolyn Britten, MD. The open-label, dose-escalation, PK and PD first-in-human
Phase I study with YELIVA((TM)) treated 21 patients with advanced solid tumors,
the majority of whom were gastrointestinal cancer patients, including
pancreatic, colorectal, cholangiocarcinoma cancers. The patients were
continuously treated in cycles of 28 days with the study drug, in the absence of
disease progression, and tumors were reimaged every two cycles. Patients were
evaluated for an additional period of up to one year after discontinuing
treatment with YELIVA((TM)).
A Phase I/II clinical study was initiated at the Louisiana State University
Health Sciences Center (LSUHSC) in New Orleans in June 2015 evaluating
YELIVA((TM)) in patients with refractory/relapsed diffuse large B-cell lymphoma
(DLBCL), including in patients with HIV-related DLBCL. Pending consideration of
protocol amendment aimed at improving recruitment prospects, the study is
currently on administrative hold. The study 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 to be initiated in the coming weeks. 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.
A Phase II study with YELIVA((TM) )for the treatment of advanced hepatocellular
carcinoma is planned to be initiated in the third quarter of 2016. The study
will be conducted at the MUSC Hollings Cancer Center and additional clinical
centers in the U.S. The study is supported by a $1.8 million grant from the NCI
awarded to MUSC, intended to support a broad range of studies on the feasibility
of targeting sphingolipid metabolism for the treatment of a variety of solid
tumor cancers, including the Phase II study with YELIVA(TM), and will be further
supported by additional funding from RedHill.
The Phase I/II clinical studies, as well as the completed 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. 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 and 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 an ongoing 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; (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 MUSC Hollings Cancer Center
The Hollings Cancer Center at the Medical University of South Carolina is a
National Cancer Institute-designated cancer center and the largest academic-
based cancer research program in South Carolina. The cancer center is comprised
of more than 120 faculty cancer scientists with a research funding portfolio of
$44 million and a dedication to reducing the cancer burden in South Carolina.
Hollings offers state-of-the-art diagnostic capabilities, therapies and surgical
techniques within multidisciplinary clinics that include surgeons, medical
oncologists, radiation therapists, radiologists, pathologists, psychologists and
other specialists equipped for the full range of cancer care, including more
than 200 clinical trials. For more information, please visit www.hcc.musc.edu.
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 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#2022188]
Datum: 21.06.2016 - 15:31 Uhr
Sprache: Deutsch
News-ID 479104
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