New Research Results Show That Investigational Drug Phenoxodiol Targets Cancer Protein, Causing Cancer Cell Death
May 01 2007 - 9:00AM
PR Newswire (US)
Worldwide pivotal phase III study in women with recurrent ovarian
cancer underway SYDNEY, Australia and WASHINGTON, May 1
/PRNewswire-FirstCall/ -- 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
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: David Sheon, +1-202-518-6321, ;
Chris Naughton, +011 61 2 9878 0088, Web site:
http://www.marshalledwardsinc.com/ http://www.novogen.com/
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