SAN DIEGO, Dec. 22, 2014 /PRNewswire/ -- MEI Pharma,
Inc. (Nasdaq: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, today announced that the
clinical response milestone has been reached in the Company's
ongoing Phase II study of its investigational drug candidate
Pracinostat in combination with a hypomethylating agent (HMA) in
patients with myelodysplastic syndrome (MDS) who previously failed
treatment with single-agent HMA.
Of the first 28 patients who received Pracinostat in combination
with azacitidine (marketed as Vidaza®) or decitabine
(marketed as Dacogen®) after progressing while being
treated with the same HMA alone, three have now achieved clinical
responses, one partial response (PR) and two marrow complete
responses (mCR), exceeding the pre-specified clinical improvement
rate for expansion of study enrollment.
"A year ago we set out to execute a comprehensive development
program for Pracinostat in order to determine the most efficient
registration path forward," said Daniel P.
Gold, Ph.D., President and Chief Executive Officer of MEI
Pharma. "The primary objective of this refractory MDS study was to
determine if the addition of Pracinostat to a hypomethylating agent
can result in clinical benefit following disease progression with a
HMA alone. Observing clinical responses in this most difficult to
treat patient population only reinforces our confidence in the
activity of Pracinostat. Now we will complete enrollment in this
study and continue to follow patients for response and survival.
Meanwhile we eagerly await the unblinding of our randomized,
placebo-controlled Phase II study in front line MDS in March 2015 as we prepare for the initiation of
our Phase III study in front line AML in June 2015."
The primary endpoint of the refractory MDS study is clinical
improvement rate, defined as the proportion of patients with CR,
mCR, PR and hematologic improvement. Secondary endpoints include
overall response rate, duration of response, transfusion
independence, progression-free survival and overall survival. The
combination of Pracinostat and azacitidine or decitabine has been
generally well-tolerated in the study, with no unexpected
toxicities. The most common treatment-emergent adverse events
include anemia, fatigue and gastrointestinal disorders.
About Pracinostat
Pracinostat is an oral histone deacetylase (HDAC) inhibitor that
has been tested in a number of Phase I and Phase II clinical trials
in advanced hematologic disorders and solid tumor indications in
both adult and pediatric patients. Pracinostat has been generally
well tolerated in more than 300 patients to date, with manageable
side effects often associated with drugs of this class, including
fatigue, myelosuppresion and gastrointestinal toxicity. In a Phase
I dose-escalation trial, Pracinostat demonstrated evidence of
single-agent activity in elderly acute myeloid leukemia (AML)
patients, including two out of 14 (14%) who achieved a CR, with
durable responses persisting 206+ and 362 days, respectively. In
addition, results from a pilot study of Pracinostat in combination
with azacitidine in patients with advanced MDS showed an overall
response rate of 90% (nine out of 10), including six patients who
achieved a CR.
Earlier this month, significant clinical activity from a Phase
II study of Pracinostat in combination with azacitidine in elderly
patients with newly diagnosed AML were reported at the American
Society of Hematology (ASH) Annual Meeting. According to the
presentation, 15 of 33 evaluable patients (45%) achieved the
primary endpoint of CR plus complete response with incomplete blood
count recovery (CRi) plus morphologic leukemia-free state. No
patient who achieved a clinical response has progressed. The
Company plans to report full top line data from all 50 patients
enrolled in the study in June
2015.
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 lead drug candidate is Pracinostat, a potential
best-in-class, oral HDAC inhibitor currently being developed for
MDS and AML. In August 2014, the
Company completed enrollment in a randomized, placebo-controlled
Phase II study of Pracinostat in combination with azacitidine in
patients with previously untreated intermediate-2 or high-risk MDS.
The Company plans to unblind the study and report topline data in
March 2015. 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 trials 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.
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SOURCE MEI Pharma, Inc.