SAN DIEGO, Nov. 5, 2015 /PRNewswire/ -- MEI Pharma, Inc.
(Nasdaq: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, today announced the
publication of new data from the Company's Phase II clinical
studies of the investigational drug Pracinostat in patients with
previously untreated myelodysplastic syndrome (MDS) and elderly
patients with acute myeloid leukemia (AML). Results from these
studies were recently selected for oral presentation at the
upcoming American Society of Hematology (ASH) Annual Meeting in
Orlando on December 7, 2015. The abstracts are now available
on the ASH website at www.hematology.org.
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"The data contained within the abstracts released this morning
point to certain trends worth highlighting," said Daniel P. Gold, Ph.D., President and Chief
Executive Officer of MEI Pharma. "Since the unblinding of our
randomized study in front-line MDS, we have learned that the
combination of Pracinostat and azacitidine resulted in a high rate
of discontinuations due to adverse events compared to azacitidine
alone. These discontinuations occurred predominantly within the
first two cycles of treatment and often before a response
assessment could be performed, leading to a higher complete
response (CR) rate overall with azacitidine alone. However,
exploratory sensitivity analyses among patients who were able to
tolerate treatment for at least four cycles (n=54) suggest that
patients treated with Pracinostat plus azacitidine appear to derive
benefit compared to azacitidine alone, with hazard ratios for
progression progression-free survival (0.37), event-free survival
(0.33) and overall survival (0.59) all favoring the Pracinostat
plus azacitidine arm.
"The data from our open-label study in elderly patients with
newly diagnosed AML," continued Dr. Gold, "demonstrate that many
patients are achieving responses within the first two cycles and
continue to improve with ongoing therapy, with fewer
discontinuations due to adverse events than in our MDS study.
Overall, 54% of patients (27 of 50) have achieved a clinical
response with 42% (21 of 50) achieving a CR. The 60-day mortality
rate in the study is 10% (5 of 50) and the one-year survival rate
is estimated at 60%. All of these data points compare favorably to
a recent study of azacitidine alone in this population1.
Median overall survival, the most important measure in determining
the development path forward for this combination, still has not
been reached. We will continue to follow these patients and look
forward to the presentation of updated overall survival data at ASH
next month."
The data contained within the abstracts listed below are as of
the ASH submission deadline on August 4,
2015. In accordance with ASH policies, information that goes
beyond that which is contained within these abstracts is embargoed
until their presentation on December 7,
2015.
Title: Final Results from a Phase 2 Study of Pracinostat
in Combination with Azacitidine in Elderly Patients with Acute
Myeloid Leukemia (Abstract #453)
Session Name: 613. Acute Myeloid Leukemia: Clinical Studies:
Advances in Therapy
Session Date: Monday, December 7,
2015
Session Time: 7:00 AM - 8:30
AM
Presentation Time: 7:30 AM
Title: A Randomized, Placebo-Controlled, Phase II Study
of Pracinostat in Combination with Azacitidine in Patients with
Previously Untreated Myelodysplastic Syndrome (Abstract #911)
Session Name: 637. Myelodysplastic Syndromes – Clinical
Studies I
Session Date: Monday, December 7,
2015
Session Time: 6:15 PM - 7:45
PM
Presentation Time: 7:15 PM
About Pracinostat
Pracinostat is an orally available inhibitor of a group of
enzymes called histone deacetylases, or HDACs. HDACs belong to a
larger set of proteins collectively known as epigenetic regulators
that can alter gene expression by chemically modifying DNA or its
associated chromosomal proteins. Abnormal activity of these
regulators is believed to play an important role in cancer and
other diseases. Pracinostat has been tested in multiple Phase I and
Phase II clinical studies in advanced hematologic diseases and
solid tumor indications. The results of these studies suggest that
Pracinostat has potential best-in-class pharmacokinetic properties
when compared to other oral HDAC inhibitors, with side effects
often associated with drugs of this class, including fatigue and
myelofibrosis. Pracinostat has not been approved for commercial
distribution in the U.S.
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 in Phase II
studies for advanced hematologic diseases. The Company is also
developing ME-344, a novel mitochondrial inhibitor that has shown
evidence of clinical activity in refractory solid tumors. In
addition, the Company has completed a first-in-human study of
PWT143, a highly selective, oral PI3K delta inhibitor. For more
information, please visit www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has
been investigated in clinical studies 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 trial 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.
1 Dombret H et al. International phase 3 study of
azacitidine vs conventional care regimens in older patients with
newly diagnosed AML with >30% blasts. Blood. 2015 May 18.
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