First Patient Treated in Phase III Ovarian Cancer Trial
November 27 2006 - 8:00AM
PR Newswire (US)
MELBOURNE, Australia, Nov. 27 /PRNewswire-FirstCall/ -- Marshall
Edwards, Inc. today announced that the first patient had commenced
treatment in the Phase III "OVATURE" clinical trial at The Royal
Women's Hospital in Melbourne, Australia. Royal Women's is one of
60 hospitals that will be participating in this multi-center
multi-national ovarian cancer study to confirm the effectiveness of
phenoxodiol in resensitizing patients to chemotherapy. Thirty of
these hospitals will be in the U.S., 25 in Europe and 5 in
Australia. 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 U.S. 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. Professor Michael Quinn of Royal Women's Hospital in
Melbourne said the Royal Women's Hospital along with the Yale
University Medical School had already conducted a Phase II study,
where phenoxodiol was shown to have a chemosensitizing effect on
ovarian cancer when chemotherapy had previously failed. "We are now
hopeful that a positive outcome of this multi-center study will be
a significant medical advance for thousands of women with late
stage ovarian cancer whose tumors have become insensitive to the
existing chemotherapeutic drugs," Professor Quinn said. The Chief
Executive Officer of Marshall Edwards, Inc., Mr. Christopher
Naughton, said the Phase III Ovature study was a significant
milestone for the Company. "Over the next 12 to 18 months we expect
the interim results from this multi-national clinical trial which
may lead to the first approval for phenoxodiol," Mr. Naughton said.
Mr. Naughton said there are also other cancer types for which
phenoxodiol has shown promise and the Company would be proceeding
in the year ahead with a strategy to expand the drug's utility into
those other cancers as both a chemosensitizer and as a monotherapy.
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 per cent of patients
being diagnosed in advanced stage of disease. 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
arty 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, CEO Marshall Edwards, Inc.,
+612-8877-6196; David Sheon, SciWords, LLC, for Marshall Edwards,
Inc., +1-202-518-6321 Web site: http://www.marshalledwardsinc.com/
http://www.novogen.com/
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