SAN DIEGO, April 10, 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 received approval from the U.S Food and Drug Administration
(FDA) of its Investigational New Drug (IND) application for ME-344,
the Company's lead mitochondrial inhibitor. The Company is now in
the process of initiating a Phase I clinical trial of intravenous
ME-344 in patients with solid refractory tumors.
"With this important milestone, we have now successfully
advanced our two most promising oncology drug candidates into the
clinic," said Daniel P. Gold, Ph.D.,
President and Chief Executive Officer of Marshall Edwards. "As we near the completion of
our Phase I clinical trial of ME-143 and prepare for its next phase
of development, we are excited to initiate our first human study of
ME-344. We believe ME-344 is a novel compound that has the
potential to significantly improve treatment outcomes for patients
with cancer, but first it is important to confirm its safety and
tolerability in patients while establishing an optimal dose for
future trials."
The Phase I clinical trial of ME-344 is being conducted in
collaboration with the Sarah Cannon Research Institute. The
open-label, dose-escalation trial will evaluate the safety and
tolerability of intravenous ME-344 in patients with refractory
solid tumors. In addition, the trial is designed to characterize
its pharmacokinetic profile and describe any preliminary clinical
anti-tumor activity observed. Patients will be administered
intravenous infusions of ME-344 once weekly for three weeks and,
after safety assessment, may continue weekly dosing if a clinical
benefit is determined. The trial is expected to enroll up to 24
patients at three sites. Additional information regarding the
trial, including enrollment criteria and site information, is
available on the U.S. National Institutes of Health (NIH) clinical
trials database at www.clinicaltrials.gov.
About ME-344
ME-344 is the Company's lead mitochondrial inhibitor and an
active metabolite of NV-128, a 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 has demonstrated far
superior anti-tumor activity against a broad range of human cancer
cell lines compared to NV-128, including breast, colorectal and
ovarian. Marshall Edwards owns
exclusive worldwide rights to all of its drug candidates, including
ME-344.
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 received approval of its Investigational
New Drug application for ME-344 in April
2012 and is in the process of initiating a Phase I clinical
trial of intravenous ME-344 in patients with solid refractory
tumors. 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.