SAN DIEGO, March 23, 2015 /PRNewswire/ -- MEI Pharma,
Inc. (Nasdaq: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, today announced top-line
data from a randomized Phase II clinical study of its
investigational drug candidate Pracinostat in combination with
azacitidine in patients with previously untreated intermediate-2 or
high-risk myelodysplastic syndrome (MDS). The double-blind,
placebo-controlled study enrolled a total of 102 patients,
randomized one-to-one, at 19 sites in the U.S.
According to the top-line data, the combination of Pracinostat
and azacitidine showed no difference in the rate of complete
remission (CR), the study's primary endpoint, compared to
azacitidine alone. Data from event-driven endpoints, including
duration of response, event and progression free survival and
overall survival, are immature and will require longer follow-up in
order to achieve meaningful conclusions. There were no new or
unexpected toxicities observed in the study. Fatigue,
gastrointestinal toxicities and myelosuppresion occurred more
frequently in the combination group and resulted in a higher rate
of drug discontinuations compared to azacitidine alone. The Company
expects to present full results of the study at a scientific
meeting later this year.
"Our goal when we initiated this study was to build on prior
data and rigorously assess the clinical benefit of Pracinostat in
combination with azacitidine in MDS," said Daniel P. Gold, Ph.D., President and Chief
Executive Officer of MEI Pharma. "While we are disappointed with
these top-line response data, we are diligently analyzing the
entire data set as well as subsets from this study. Specifically,
we are trying to fully assess the impacts of discontinuations on
clinically important efficacy outcomes, including duration of
response, event and progression free survival and overall survival.
These findings will be important to inform the future development
path for Pracinostat."
At the American Society of Hematology (ASH) Annual Meeting In
December 2014, the company reported
significant clinical activity from 33 evaluable patients in an
open-label, single-arm Phase II study of Pracinostat and
azacitidine in elderly patients with newly diagnosed acute myeloid
leukemia (AML). Further follow-up indicates that the response rate
and overall survival of these patients continued to increase. To
date, 12 patients have been on study for more than six months,
including five who have surpassed one year. Data from all 50
patients enrolled in this study have been submitted for
presentation at the European Hematology Association (EHA) Annual
Congress in June 2015.
"AML represents another important component of our Pracinostat
development strategy," continued Dr. Gold. "We remain encouraged by
the durable responses and long-term tolerability observed in our
ongoing Phase II study and will continue to monitor these patients
closely to get a better estimate of the survival benefit. However,
we do not intend to initiate any further studies of Pracinostat and
azacitidine until we have gained a more complete understanding of
the totality of clinical data surrounding the combination. We
expect to be in a position to share more information regarding
these findings and future development plans for Pracinostat later
this year."
About Pracinostat
Pracinostat is an oral histone deacetylase (HDAC) inhibitor that
has been tested in a number of Phase I and Phase II clinical
studies in advanced hematologic disorders and solid tumor
indications. Pracinostat has been generally well tolerated in more
than 300 patients, with manageable side effects often associated
with drugs of this class, notably fatigue. Pracinostat has
exhibited pharmacokinetic properties in these studies that compare
favorably to other oral HDAC inhibitors, including
Zolinza® (vorinostat) and Farydak®
(panobinostat).
MEI Pharma owns exclusive worldwide rights to Pracinostat.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on
the clinical development of novel therapies for cancer. The
Company's portfolio of drug candidates includes Pracinostat, a
potential best-in-class, oral HDAC inhibitor currently being
developed for advanced hematologic diseases, such as MDS and AML.
MEI Pharma is also developing ME-344, a mitochondrial inhibitor
currently in a Phase Ib study in combination with topotecan in
patients with small cell lung or ovarian cancer who failed initial
therapy. In addition, the Company expects to initiate a
first-in-human study of PWT143, a highly selective PI3K delta
inhibitor, in the first half of 2015.
Under U.S. law, a new drug cannot be marketed until it has
been investigated in clinical studys and approved by the FDA as
being safe and effective for the intended use. Statements included
in this press release that are not historical in nature are
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are
subject to a number of risks and uncertainties, including, but not
limited to, our failure to successfully commercialize our product
candidates; costs and delays in the development and/or FDA
approval, or the failure to obtain such approval, of our product
candidates; uncertainties or differences in interpretation in
clinical study results; our inability to maintain or enter into,
and the risks resulting from our dependence upon, collaboration or
contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution
of any products; competitive factors; our inability to protect our
patents or proprietary rights and obtain necessary rights to third
party patents and intellectual property to operate our business;
our inability to operate our business without infringing the
patents and proprietary rights of others; general economic
conditions; the failure of any products to gain market acceptance;
our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry
practice; and one-time events. We do not intend to update any of
these factors or to publicly announce the results of any revisions
to these forward-looking statements.
Zolinza® is a registered trademark
of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Inc. Farydak® is a registered trademark of
Novartis AG.
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SOURCE MEI Pharma, Inc.