Marshall Edwards, Inc. Announces Initial Trial Sites, Principle Investigator for Phase III OVATURE Trial for Phenoxodiol
December 12 2006 - 7:41PM
PR Newswire (US)
WASHINGTON, Dec. 12 /PRNewswire-FirstCall/ -- Marshall Edwards,
Inc. today announced that the pivotal trial for its lead
investigational anti-cancer drug phenoxodiol is on schedule and
that trial sites have been established on three continents. The
comments were made at the annual shareholder meeting held here
today. In the United States, negotiations have begun with 9 trial
sites. Yale University School of Medicine and US Oncology have
submitted the protocol to their respective institutional review
boards and are awaiting clearance to begin enrollment. US Oncology
has cancer treatment centers in over 30 states. The Company is
negotiating with 20 sites in Europe, and has already signed 5 sites
in Australia for the trial. The Company also announced that Thomas
Rutherford, M.D. Associate Professor of Gynecology and Reproductive
Sciences at Yale University School of Medicine, will be a principal
investigator for the OVATURE trial. The OVATURE trial is a
multi-center multi-national ovarian cancer study to confirm the
effectiveness of phenoxodiol in resensitizing patients to
chemotherapy. The total number of patients to be treated in this
pivotal study is 470, with half to be on a treatment regime of
phenoxodiol and the chemotherapeutic drug carboplatin, and half on
a placebo and carboplatin. The primary outcome of the trial is the
assessment of the relative time it takes for the ovarian cancer to
progress. An analysis of interim results will be possible after 95
patients have progressed with their disease. The trial is being run
under arrangements approved by the US Food and Drug Administration
(FDA) known as a Special Protocol Assessment (SPA). This provides
for the interim analysis of the data, which if significant can be
used to support a request for grant of marketing approval. Ovarian
cancer is the most lethal gynecological malignancy and the fifth
leading cause of cancer-related death in women in the United
States. The high mortality rate is due mainly to the inability to
detect early disease with approximately 80 percent of patients
being diagnosed in advanced stage of disease. The Company also
announced today that it will not be extending the expiration date
of its existing warrants that are scheduled to expire on December
16, 2006. About Phenoxodiol Phenoxodiol is an investigational drug
and, as such, is not commercially available. Phenoxodiol is a
novel-acting drug that inhibits key pro-survival signaling pathways
operating via sphingosine-1-phosphate and Akt. Inhibition of these
pathways leads to prevention of phosphorylation of key
anti-apoptotic proteins such as XIAP. Loss of activity of these
proteins restores the ability of chemoresistant tumor cells to
undergo apoptosis in response to chemotherapy. The putative
molecular target for phenoxodiol is a tumor- specific protein,
accounting for the highly selective nature of the drug. About
Marshall Edwards, Inc. Marshall Edwards, Inc. (NASDAQ:MSHL) has
licensed rights from Novogen Limited (NASDAQ:NVGN) to bring three
oncology drugs -- phenoxodiol, NV-196 and NV-143 -- to market
globally. Marshall Edwards, Inc. is majority owned by Novogen, an
Australian biotechnology company that is specializing in the
development of therapeutics based on a flavonoid technology
platform. Novogen, based in Sydney, Australia, is developing a
range of therapeutics across the fields of oncology, cardiovascular
disease and inflammatory diseases. More information on phenoxodiol
and on the Novogen group of companies can be found at
http://www.marshalledwardsinc.com/ and http://www.novogen.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 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. DATASOURCE:
Marshall Edwards, Inc. CONTACT: Christopher Naughton of Marshall
Edwards, Inc., 011 612 8877 6196; or David Sheon for Marshall
Edwards, Inc., +1-202-518-6321 Web site:
http://www.marshalledwardsinc.com/ http://www.novogen.com/
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