MEI Pharma's Mitochondrial Inhibitor Drug Candidate ME-344 Named
One of Top 10 Oncology Products for 2012
SAN DIEGO, Nov. 19, 2012 /PRNewswire/ -- MEI Pharma,
Inc. (Nasdaq: MEIP), an oncology company focused on the clinical
development of novel therapies for cancer, announced today that its
lead mitochondrial inhibitor drug candidate, ME-344, has been named
one of the Top 10 Most Licensable Oncology Products to Watch for
2012 by Elsevier Business Intelligence and Campbell Alliance.
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"We are honored to have ME-344 considered among the most
attractive oncology opportunities in the industry," said
Daniel P. Gold, Ph.D., President and
Chief Executive Officer of MEI Pharma. "We believe ME-344 is a
novel compound with a unique mechanism of action that has the
potential to complement standards-of-care and significantly improve
treatment outcomes for patients with cancer. Our Phase I clinical
trial of ME-344 in patients with solid refractory tumors is nearing
completion of enrollment and we look forward to reporting its
results, along with our plans for its next phase of clinical
development, during the second quarter of 2013."
Projects were selected using a set of judging criteria that
included unmet medical need, market potential, diversity of
indications, strong science, multi-level partnering opportunities
(biotech and pharma), potential for new opportunities beyond
initial indications and corporate stability. Selected projects will
be presented at the Windhover Therapeutic Area Partnerships
conference in Boston on
November 29, 2012. More information
can be found at www.tapartnerships.com.
About ME-344
ME-344 is MEI Pharma's lead mitochondrial inhibitor and an
active metabolite of NV-128, its first-generation compound. In
April 2011, Ayesha Alvero, M.D., Department of Obstetrics,
Gynecology and Reproductive Sciences at Yale
University School of Medicine, presented data at the
American Association for Cancer Research Annual Meeting from a
pre-clinical study of NV-128 demonstrating its ability to induce
mitochondrial instability, ultimately leading to cell death in
otherwise chemotherapy-resistant ovarian cancer stem cells. These
results were later published in the August
2011 issue of Molecular Cancer Therapeutics. In
additional pre-clinical studies, ME-344 demonstrated superior
anti-tumor activity against a broad range of human cancer cell
lines compared to NV-128.
A Phase I trial of intravenous ME-344 in patients with solid
refractory tumors is ongoing. The trial is evaluating the safety
and tolerability of intravenous ME-344 in five escalating dose
cohorts and is expected to enroll up to 24 patients. Dosing of the
fourth cohort (10 mg/kg) is nearly complete; no dose-limiting
toxicities have been observed to date. Final safety and
pharmacokinetic data is expected in the second quarter of 2013.
MEI Pharma owns exclusive worldwide rights to all of its drug
candidates, including ME-344.
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 histone deacetylase (HDAC) inhibitor, which has
been tested in multiple Phase I and pilot Phase II clinical trials,
including advanced hematologic malignancies such as myelodysplastic
syndrome (MDS), acute myeloid leukemia and myelofibrosis. The
Company expects to initiate a randomized Phase II trial of
Pracinostat in combination with azacitidine in patients with MDS by
the second quarter of 2013. In addition, MEI Pharma is developing
two drug candidates derived from its isoflavone-based technology
platform, ME-143 and ME-344. For more information, go to
www.meipharma.com.
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.
SOURCE MEI Pharma, Inc.