Early Study Provides Evidence That Investigational Drug Phenoxodiol Targets Prostate Cancer Protein
September 18 2006 - 9:51AM
PR Newswire (US)
STAMFORD, Conn. and SYDNEY, Australia, Sept. 18
/PRNewswire-FirstCall/ -- Novogen Limited's subsidiary, Marshall
Edwards, Inc. (NASDAQ:MSHL) (London AIM: MSH) has just made the
following announcement. Early study provides evidence that
investigational drug phenoxodiol targets prostate cancer protein.
CHICAGO -- September 14, 2006 -- 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. (MEI)
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. 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. More
information on the Novogen group of companies can be found at
http://www.novogen.com/. DATASOURCE: Novogen Limited CONTACT: David
Sheon, +1-202 518-6321, for Novogen Limited; or Mr. Christopher
Naughton, Managing Director of Novogen Limited, +011 61 (02) 9878
0088 Web site: http://www.phenoxodiol.com/ http://www.novogen.com/
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