A new
study further supports the unique mechanism of action of phenoxodiol, an
investigational drug being studied for the treatment of ovarian cancer. The
drug appears to work by targeting a certain tumor-specific protein, which
triggers a series of events that selectively induce cancer cell death.
Phenoxodiol is currently being studied in patients with resistant ovarian
cancer, a disease that is estimated to kill more than 15,000 women this
year in the U.S. alone.
In studies conducted thus far, phenoxodiol has exhibited an excellent
safety profile, with few patients experiencing side effects attributed to
the drug.
The new research was conducted by a team headed by Research Professor
Michael Berridge Ph.D., at the Malaghan Institute of Medical Research - New
Zealand's leading medical research facility focused on finding cures for
cancer and other diseases.
Findings from the study, to be presented at the New Zealand Society of
Oncology meeting to be held May 9-11, help explain the mechanism by which
phenoxodiol induces cancer cell death. This new research supports previous
findings by Professor James Morre, Ph.D. at Purdue University, which showed
that phenoxodiol interacts with the tumor-specific protein, tNOX, to
selectively block cancerous cells from dividing by switching off a variety
of pro-survival signaling mechanisms within the cancer cell, causing it to
die.
In cases of late-stage ovarian cancer, standard chemotherapy drugs
often have a limited duration of use. The cancer can progressively lose its
sensitivity to chemotherapy until cancer cells become unresponsive causing
resistance, a major barrier to successful cancer treatment. In laboratory
studies and Phase II clinical trials, phenoxodiol showed promise in
restoring drug sensitivity to resistant cancer cells.
"Phenoxodiol has a unique mechanism of action not exhibited by other
anticancer drugs in current use.," said Dr. Berridge. "By inhibiting plasma
membrane electron transport selectively in cancer cells, phenoxodiol
subjects these cells to stress that leads to cell death. This novel drug
and its related analogues have the potential to enhance anticancer efficacy
by a different mechanism, promising a new approach to management of solid
tumors in a range of clinical settings. As the first compound to operate
via this pathway, confirmatory evidence to validate the mechanism of action
is very desirable."
Specific Findings Identify Specific Proteins Associated with Unlocking
the Mystery for Why Cancer Cells don't Die the Way Healthy Cells Do
Evidence from this new study indicates that phenoxodiol inhibits
proliferation of many cancer cell lines and some primary immune cells.
Phenoxodiol induces the destruction of cancer cells by disrupting a stress
pathway in the outer cell membrane, causing down regulation of the
FLICE-inhibitory protein, FLIP, and resulting in caspase-dependent and
independent degradation of the X-linked inhibitor of cell death, XIAP.
Phenoxodiol selectively limits plasma membrane electron transport in
cancer cells, by binding to a cancer specific surface plasma membrane
electron transport element on cancer cells thereby inhibiting their
proliferation, whereas the compound has no such effect on normal healthy
cells.
Multinational trial underway
Phenoxodiol in combination with carboplatin is currently being studied
in a multi-national Phase III clinical trial called OVATURE, following
positive findings of previous trials conducted at Yale-New Haven Hospital.
The OVATURE trial will take place in 60 sites in the United States, Europe,
and Australia. Preliminary results from the trial are expected within 18
months.
About phenoxodiol:
Phenoxodiol is being developed as a therapy for late-stage,
chemo-resistant prostate, ovarian and cervical cancers. Phenoxodiol is an
investigational drug and, as such, is not commercially available. It 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) is a specialist oncology company
focused on the clinical development of novel anti-cancer therapeutics.
These derive from a flavonoid technology platform which has generated a
number of novel compounds characterized by broad ranging efficacy against a
range of cancer targets with few side effects. The unique combination of
efficacy and safety has been explained by their ability to target an enzyme
present on the surface of cancer cells, thereby inhibiting the production
of pro-survival proteins within the cell. Marshall Edwards, Inc. 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
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of any revisions to these forward-looking statements.
Marshall Edwards Inc.
marshalledwardsinc
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