SAN DIEGO, June 4, 2012 /PRNewswire/ -- Marshall
Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the
clinical development of novel therapeutics targeting cancer
metabolism, announced results from a Phase I clinical trial of its
lead drug candidate ME-143 in patients with solid refractory
tumors. The data were presented at the American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago today.
"We are encouraged by the results from this first-in-human study
of ME-143," said presenter and co-investigator Carla Kurkjian, MD, University of Oklahoma Health Sciences Center.
"ME-143 appears to be generally well tolerated with minimal
toxicity as a single agent in heavily treated patients. We look
forward to further studies of ME-143 in combination with cytotoxic
therapies."
A copy of today's poster presentation, entitled "ME-143, a novel
inhibitor of tumor-specific NADH oxidase (tNOX): Results from a
first-in-human phase I study," is available at
www.marshalledwardsinc.com.
The Phase I trial of ME-143 was initiated in September 2011 following the approval of an
Investigational New Drug (IND) application by the U.S. Food and
Drug Administration. The open label trial was designed to evaluate
the safety and tolerability of intravenous ME-143, the Company's
next-generation NADH oxidase inhibitor, in patients with refractory
solid tumors and characterize its pharmacokinetic profile. A total
of 15 patients were enrolled in escalating dose cohorts of 2.5
mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. The median number of prior
therapies was four. Stable disease was observed in one patient at
more than 15 weeks, which is comparable to Phase I studies of
Phenoxodiol, the Company's first-generation NADH oxidase inhibitor,
in which stable disease was also the best response observed. ME-143
was generally well tolerated at all dose levels on a weekly dosing
schedule and the maximum tolerated dose was defined as 20
mg/kg.
"We have achieved our main objective in this trial," said
Robert Mass, M.D., Chief Medical
Officer of Marshall Edwards,
"specifically, to establish a recommended dose for the next phase
of development with ME-143. With the exception of a serious
infusion reaction in one patient at the highest dose level, ME-143
was generally well tolerated. In addition, the pharmacokinetic
profile of intravenous ME-143 resulted in drug levels that were
approximately 30 times higher than the exposure achieved in a Phase
II trial of intravenous Phenoxodiol in combination with
platinum-based chemotherapy in women with platinum-resistant
ovarian cancer[1]. These results enable us to better prepare for
the first of our Phase II efficacy studies of ME-143 in combination
with standard-of-care chemotherapy later this year."
About ME-143
ME-143 is Marshall Edwards' lead
NADH oxidase inhibitor drug candidate. In pre-clinical studies,
ME-143 demonstrated superior anti-tumor activity against a number
of tumor cell lines compared to Phenoxodiol, the Company's
first-generation NADH oxidase inhibitor, including breast,
colorectal and ovarian. In addition to broad single-agent activity,
ME-143 has also shown a far superior ability to enhance the
cytotoxic effects of chemotherapy in pre-clinical studies as
compared to Phenoxodiol. Marshall
Edwards owns exclusive worldwide rights to ME-143. ME-143 is
an investigational drug and has not been approved by the FDA for
commercial distribution in the U.S. or other countries.
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
presented safety and pharmacokinetic data from a Phase I clinical
trial of intravenous ME-143 in patients with solid refractory
tumors at the American Society of Clinical Oncology Annual Meeting
in June 2012 and plans to initiate a
Phase II clinical trial of intravenous ME-143 in combination with
chemotherapy by year-end. The Company received approval of its IND
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.
[1] Kelly et al. Phase II Evaluation of Phenoxodiol in
Combination With Cisplatin or Paclitaxel in Women With
Platinum/Taxane-Refractory/Resistant Epithelial Ovarian, Fallopian
Tube, or Primary Peritoneal Cancers. Int J Gynecol Cancer.
2011 May;21(4):633-9.
SOURCE Marshall Edwards, Inc.