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 marshalledwardsinc and
novogen.
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.
Marshall Edwards, Inc.
marshalledwardsinc