SAN DIEGO, May 29, 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 first cohort of patients has
been dosed in a Phase I clinical trial of ME-344, the Company's
lead mitochondrial inhibitor drug candidate, in patients with
refractory solid tumors. The dose escalation trial is expected to
enroll up to 24 patients in up to five cohorts with final safety
and pharmacokinetic data expected in the first half of 2013.
"We are very pleased to see the excitement surrounding our
initial clinical trial of ME-344, with the first cohort of patients
now well underway just a month after our Investigational New Drug
application was approved by the FDA," said Robert D. Mass, MD, Chief Medical Officer of
Marshall Edwards. "ME-344 is a novel
compound that showed compelling anti-tumor activity in pre-clinical
studies. Now we look forward to gathering valuable clinical data in
the months ahead, all of which will help to optimize the design of
our Phase II efficacy studies."
The Phase I clinical trial is evaluating the safety and
tolerability of intravenous ME-344 in escalating dose cohorts of
1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. In addition,
the trial is designed to characterize the pharmacokinetic profile
of ME-344 and describe any preliminary clinical anti-tumor activity
observed. Patients in the trial are 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 open-label trial is being conducted in collaboration with
the Sarah Cannon Research Institute at three sites: Florida Cancer
Specialists in Sarasota,
University of Oklahoma in Oklahoma City and Tennessee Oncology in
Nashville. Additional information
regarding the trial, including enrollment criteria, is available on
the U.S. National Institutes of Health (NIH) clinical trials
database at www.clinicaltrials.gov.
About ME-344
ME-344 is Marshall Edwards' lead
mitochondrial inhibitor and an active metabolite of NV-128, the
Company's 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 initiated a Phase I clinical trial of intravenous
ME-344 in patients with solid refractory tumors shortly thereafter.
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.