SAN DIEGO, March 6, 2012 /PRNewswire/ -- Marshall
Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the
clinical development of novel therapeutics targeting cancer
metabolism, announced today that it has submitted an
Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA) to initiate clinical testing for oncology
drug candidate ME-344, the Company's lead mitochondrial
inhibitor.
"I am extremely proud of our clinical operations and
pre-clinical research teams in reaching this important milestone,
less than seven months since our IND for ME-143 was approved by the
FDA to begin clinical testing," said Daniel
P. Gold, Ph.D., President and Chief Executive Officer of
Marshall Edwards. "We are prepared
to initiate a Phase I clinical trial of intravenous ME-344 in
patients with solid refractory tumors immediately following
approval by the FDA."
Marshall Edwards also announced
that it has commenced dosing of the fourth cohort in its Phase I
clinical trial of intravenous ME-143 in patients with solid
refractory tumors. The Company expects to collect final safety and
pharmacokinetic data from this trial by June.
"We continue to execute on the clinical development plan we set
forth for our two most promising drug candidates," said
Robert Mass, M.D., Chief Medical
Officer of Marshall Edwards. "Now,
as we await approval of our IND for ME-344 and near the completion
of enrollment in our Phase I clinical trial of ME-143, we are
diligently preparing for our Phase II trials."
Marshall Edwards owns exclusive
worldwide rights to all of its drug candidates, including ME-143
and ME-344.
About ME-344
ME-344 is Marshall Edwards'
lead mitochondrial inhibitor and an active metabolite of NV-128, a
first-generation compound. Treatment of tumor cells with the
Company's mitochondrial inhibitor compounds induces a rapid loss of
cellular energy and leads to the inhibition of both mammalian
target of rapamycin (mTOR1 and mTOR2) pathways. 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 has demonstrated far
superior anti-tumor activity against a broad range of human cancer
cell lines compared to NV-128.
About Marshall Edwards
Marshall Edwards, Inc.
(Nasdaq: MSHL) is a San
Diego-based oncology company focused on the clinical
development of novel therapeutics targeting cancer metabolism. The
Company's lead drug candidates, ME-143 and ME-344, have been shown
to interact with specific enzyme targets resulting in inhibition of
tumor cell metabolism, a function critical for cancer cell
survival. Marshall Edwards initiated
a Phase I clinical trial of intravenous ME-143 in patients with
solid refractory tumors in September
2011 and expects to collect final safety and pharmacokinetic
data from the trial by June 2012. The
Company submitted an Investigational New Drug application for
ME-344 in March 2012 and plans to
initiate a Phase I clinical trial of intravenous ME-344 in patients
with solid refractory tumors following approval by the FDA. For
more information, please visit www.marshalledwardsinc.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 Marshall Edwards, Inc.
