SAN DIEGO, Jan. 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 the U.S. Patent and Trademark
Office has issued a new method of use patent, U.S. Patent No.
8,084,628, covering a number of the Company's mitochondrial
inhibitor compounds, including lead drug candidate ME-344, for the
treatment of cancer or a tumor mass. The patent is expected to
provide protection until September
2025.
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. The Company has completed the necessary
pre-clinical animal toxicity studies to support submission of an
Investigational New Drug (IND) application for ME-344 this quarter,
and expects to initiate a Phase I clinical trial of intravenous
ME-344 shortly thereafter.
"Given the increased interest in oncology compounds that can
impact both the mTOR1 and mTOR2 pathways, we are particularly
pleased to receive patent coverage for the use of ME-344 in
cancer," said Daniel P. Gold, Ph.D.,
President and Chief Executive Officer of Marshall Edwards. "This new patent reaffirms our
ongoing commitment to expanding and strengthening our intellectual
property portfolio while adding to the value of our drug
development pipeline. A strong patent estate is essential to the
commercial potential of our drug candidates and should be
recognized by potential partners."
About Marshall Edwards
Marshall Edwards, Inc. (Nasdaq:
MSHL) is a San Diego-based
oncology company focused on the clinical development of novel
anti-cancer therapeutics. The Company's lead programs focus on two
families of small molecules that result in the inhibition of tumor
cell metabolism. The first and most advanced is a NADH oxidase
inhibitor program that includes lead candidate ME-143. The Company
initiated a Phase I clinical trial of intravenous ME-143 in
patients with solid refractory tumors in September 2011 and expects final data from the
trial by the second quarter of 2012. The second program is a family
of mitochondrial inhibitors that includes lead candidate ME-344.
The Company has completed the necessary pre-clinical animal
toxicity studies to support submission of an Investigational New
Drug (IND) application for ME-344 in the first quarter of 2012. 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.