Early Study Provides Evidence That Investigational Drug Phenoxodiol Targets Prostate Cancer Protein
September 15 2006 - 9:50AM
PR Newswire (US)
CHICAGO, Sept. 15 /PRNewswire-FirstCall/ -- A new study
demonstrates that the investigational drug, phenoxodiol, may be
effective in the treatment of prostate cancer through its ability
to target a protein that appears to be selective for prostate
cancer cells. Prostate cancer is one of the most serious and common
types of cancer found in American men, killing more than 30,000 men
in the U.S. every year. In a new study, a research group headed by
James Morre, Ph.D., professor of medicinal chemistry at Purdue
University, obtained results supporting that phenoxodiol
specifically targets a protein on prostate cancer cells known as
tNOX 75 alpha. The Purdue team has identified the protein,
tumor-associated NADH oxidase (or tNOX), as a pan-cancer marker.
The protein is critical to the ability of the tumor cell to grow
and to survive. They also have shown that there are different forms
of this protein, known as isoforms, and that different tNOX
isoforms are associated with different forms of cancer. The team
has demonstrated previously that tNOX is the primary molecular
target for phenoxodiol. The 75 alpha protein appears to be the
particular tNOX isoform found in prostate cancer patients, and that
is one of the isoforms targeted by phenoxodiol. Prostate specific
antigen (PSA) is another protein found exclusively on prostate
cancer cells, and is used widely to diagnose prostate cancer and to
determine response to therapy. However, no anti-cancer drug
specifically targets PSA because the protein is not essential to
tumor cell survival, so it is not a universally reliable marker of
the efficacy of a particular drug. tNOX is essential for tumor cell
survival, making it an excellent target for anti-cancer drug
activity. When phenoxodiol binds to tNOX, the protein is inhibited,
blocking the cell from dividing, and switching off a variety of
pro-survival signaling mechanisms within the cell. Where this
inhibition reaches a certain level, the cell dies; where it is
below a lethal level, the cell is blocked from dividing. Results of
the study, which involved 19 patients with late-stage, hormone-
refractory prostate cancer, were presented today at the
International Conference on Molecular Diagnostics in Cancer
Therapeutics, held September 12th to the 15th by the American
Association of Cancer Research. In the clinical study, phenoxodiol
was administered orally three times daily until patients showed
disease progression. Blood samples were obtained prior to
treatment, after two months of treatment, and at the completion of
the schedule. All 19 patients had tNOX 75 alpha in their
bloodstream; it has not been found in patients without evidence of
cancer. Blood analysis revealed that tNOX 75 alpha levels responded
to administration of phenoxodiol in 11 of the 19 patients. "The
study demonstrates a clear association between tNOX 75 alpha
levels, prostate cancer, and response to phenoxodiol therapy," says
Graham Kelly Ph.D., Chairman of Marshall Edwards Inc., the company
developing phenoxodiol. "In the study, tNOX 75alpha levels fell as
the dosage of phenoxodiol increased, and patients responded by
slowing down the rate of tumor growth. This supports that tNOX is
the target for phenoxodiol, and that inhibition of this protein is
an exciting new approach to the treatment of cancer." About
Prostate Cancer According to data provided by the American Cancer
Society (ACS), prostate cancer is one of the most common types of
cancer found in American men, second only to skin cancer. ACS
estimates that there will be more than 232,000 new cases of
prostate cancer in the United States in 2005 and about 30,350 men
will die of this disease. One man in six will get prostate cancer
during his lifetime, and one in 34 will die of the disease. Most
cases of prostate cancer are sensitive to male sex hormones
(androgen), and blocking the effect of these hormones is a common
therapeutic process. Ultimately, however, most prostate cancers
become insensitive to androgens, at which time the tumor is
referred to as being hormone-refractory. The approved anti-tumor
therapy for these patients is docetaxel (Taxotere(R)), which has
been shown to provide a modest extension of survival in some
patients, before the tumors become docetaxel-refractory.
Hormone-refractory, docetaxel refractory patients represent the
end-stage of this disease. About Phenoxodiol Phenoxodiol is being
developed as a therapy for late-stage, chemo- resistant prostate,
ovarian and cervical cancers. Phenoxodiol targets the tNOX protein,
which regulates a number of vital cell functions, including a
hydrogen excretion pump. Inhibition of tNOX leads to inhibition of
this pump and loss of the cell's redox potential, producing a
generalized biochemical disruption including inhibition of
phosphorylation of the key pro-survival sphingosine-1-phosphate and
Akt signaling pathways. Inhibition of production of anti-apoptotic
proteins including XIAP is a key biochemical outcome. The mechanism
of action of phenoxodiol suggests a potential to be used both as a
single-agent therapy and in combination with standard anti-cancer
drugs where it acts to enhance the efficacy of those drugs in
chemo-sensitive patients and to restore sensitivity to those drugs
in chemo-resistant patients. Phenoxodiol currently is undergoing
clinical studies in the US and Australia. Phenoxodiol is an
investigational drug and, as such, is not marketed in the US. More
information about phenoxodiol can be found at
http://www.phenoxodiol.com/. About Marshall Edwards, Inc. Marshall
Edwards, Inc., (NASDAQ:MSHL) has licensed rights to bring
phenoxodiol to market globally from its parent company, Novogen
Limited. (ASX:NRT)(NASDAQ:NVGN). Novogen is developing a range of
therapeutics across the fields of oncology, cardiovascular disease
and inflammatory diseases based on its phenolic drug technology
platform. More information on the Novogen group of companies can be
found at 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, , for Marshall Edwards, Inc.
Web site: http://www.novogen.com/ http://www.phenoxodiol.com/
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