SAN DIEGO, April 3, 2012 /PRNewswire/ -- Marshall
Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the
clinical development of novel therapeutics targeting cancer
metabolism, announced today that data from a Phase I clinical trial
of the Company's lead drug candidate ME-143 has been selected for
presentation at the American Society of Clinical Oncology (ASCO)
Annual Meeting, to be held June 1-5,
2012, in Chicago. An
abstract of the presentation, entitled "ME-143, a novel inhibitor
of tumor-specific NADH oxidase (tNOX): Results from a
first-in-human phase I study," will be available online at
www.asco.org approximately two weeks before the Annual Meeting.
"This represents an exciting opportunity to present the data
from our trial of ME-143 to oncology thought leaders from around
the world," said Robert Mass, M.D.,
Chief Medical Officer of Marshall
Edwards. "These data will be instrumental as we prepare for
the first of our randomized Phase II clinical trials later this
year. We are grateful for the ongoing commitment of the clinical
investigators, trial coordinators and especially the patients who
participated in this study."
Marshall Edwards recently
completed enrollment of the fourth cohort in the Phase I clinical
trial of ME-143. The dose-escalation trial is evaluating the safety
and tolerability of ME-143 in patients with refractory solid
tumors. In addition, the trial is designed to characterize the
pharmacokinetic profile of intravenous ME-143 and describe any
preliminary clinical anti-tumor activity observed. The multi-center
trial is being conducted in collaboration with the Sarah Cannon
Research Institute.
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 in laboratory
studies 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 plans to present safety and
pharmacokinetic data from the trial at the American Society of
Clinical Oncology Annual Meeting in 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 immediately
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.