SAN DIEGO, April 20, 2016 /PRNewswire/ -- MEI Pharma,
Inc. (Nasdaq: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, announced new clinical
data from a first-in-human study of MEI Pharma's investigational
drug candidate, ME-401, a next generation oral PI3K delta
inhibitor. The data, presented today at the American Association
for Cancer Research (AACR) Annual Meeting in New Orleans, suggest that ME-401 has an
excellent pharmacokinetic (PK) and pharmacodynamic (PD) profile and
the potential for an improved therapeutic window compared to other
PI3K delta inhibitors, including the approved drug idelalisib
(marketed as Zydelig®), with a half-life that supports
once-daily dosing.
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A copy of the poster presentation, entitled, "Clinical
Pharmacokinetics and Pharmacodynamics of ME-401, an Oral, Potent,
and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ,
Following Single Ascending Administration to Healthy Volunteers,"
is now available at www.meipharma.com.
"PI3K delta is a class of drugs that has shown great promise in
the treatment of B-cell malignancies, but with certain toxicities,"
said Daniel P. Gold, Ph.D.,
President and Chief Executive Officer of MEI Pharma. "We believe
this provides an opportunity for a next-generation drug that can
produce therapeutic responses at a safe, effective dose. Thus far,
ME-401 has demonstrated all of the attributes we had hoped to see,
including linear PK and on-target activity at very low
concentrations. Now the goal of our upcoming Phase Ib study will be
to show a large therapeutic window in cancer patients. We expect to
dose the first patient in this study by the end of June and look
forward to providing an update later this year."
The Phase I study was designed to assess the safety and
tolerability of ME-401 after single ascending oral doses in healthy
volunteers to select the most appropriate dose for further clinical
evaluation. The open label study enrolled a total of 15 healthy
volunteers in 10, 30, 60, 90 and 150 mg dose levels. ME-401 was
well tolerated at all dose levels. One subject experienced two
treatment-emergent adverse events that were considered
drug-related: pain and headache, graded as mild, after a 60 mg
dose.
The first-in-human study of ME-401 was conducted using Quotient
Clinical's Translational Pharmaceutics® platform, which
collected PK/PD data immediately after each dose and allowed for
real-time decision making and manufacturing between dose
groups.
About ME-401
ME-401 (formerly PWT143) is an orally bioavailable, potent and
selective inhibitor of phosphatidylinositol 3 kinase (PI3K) delta,
a molecular target that has been shown to play a critical role in
the proliferation and survival of certain hematologic cancer cells.
ME-401 has a distinct chemical structure from other PI3K delta
inhibitors, including idelalisib. Data presented at the American
Society of Hematology Annual Meeting in December 2012 demonstrated that ME-401 has
superior pre-clinical activity compared to idelalisib. In
March 2015, the U.S. Food and Drug
Administration approved an Investigational New Drug application for
ME-401 in B-cell malignancies. MEI Pharma expects to initiate a
Phase Ib dose-escalation study of ME-401 in patients with
relapsed/refractory chronic lymphocytic leukemia (CLL) or
follicular non-Hodgkin's lymphoma (fNHL) in June 2016. The study is expected to enroll 42-84
patients at approximately 10 sites, with a starting dose of 60
mg.
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 that showed positive results in
a Phase II clinical study in combination with azacitidine (marketed
as Vidaza®) in elderly patients with newly diagnosed
acute myeloid leukemia (AML). The Company expects to initiate a
Phase III study of Pracinostat in the second half of 2016. MEI
Pharma's portfolio of drug candidates also includes ME-401, a
highly selective oral PI3K delta inhibitor that is expected to
enter a Phase Ib study in patients with recurrent CLL or fNHL in
June 2016. The Company is also
developing ME-344, a novel mitochondrial inhibitor that is prepared
to begin an investigator-sponsored study in combination with
bevacizumab (marketed as Avastin®) in HER2-negative
breast cancer. 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.
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SOURCE MEI Pharma, Inc.