FDA Grants Fast Track Designation for Phenoxodiol in Oral Dosage Form for Prostate Cancer
January 26 2005 - 8:37AM
PR Newswire (US)
FDA Grants Fast Track Designation for Phenoxodiol in Oral Dosage
Form for Prostate Cancer WASHINGTON, Jan. 26 /PRNewswire-FirstCall/
-- Marshall Edwards, Inc., (NASDAQ:MSHL) (LSE AIM: MSH) today
announced that the U.S. Food and Drug Administration (FDA) has
granted the investigational anti-cancer drug, phenoxodiol, fast
track status for its intended use in patients with hormone-
refractory prostate cancer (HRPC). The successful application for
fast track status was based on data derived in a Phase Ib/IIa
study, conducted in two Australian hospitals, in which men with
late stage HRPC were treated with the oral dosage form of
phenoxodiol as a monotherapy. The preliminary outcome of this study
was presented to the American Association of Cancer Research (AACR)
conference on Basic, Translational and Clinical Advances in
Prostate Cancer in November 2004 (for the press release and study
findings, see http://tinyurl.com/5zeck). In the study, dosages of
phenoxodiol ranging from 200mg to 400mg 8-hourly had a significant
effect on disease progression, as evidenced by falls in PSA levels,
and suppression of those levels for a period of at least 6 months.
Most of the patients remain on phenoxodiol therapy for periods up
to 18 months without evidence of disease progression. Of particular
relevance to the FDA is that prostatic adenocarcinoma that is
refractory to both hormonal therapy and cytotoxic chemotherapy is
associated with severe morbidity and a life expectancy of less than
1 year, and as such meets the criteria for a serious and
life-threatening disease. Under the FDA Modernization Act of 1997,
designation as a Fast Track product means that the drug for the
designated indication is eligible for accelerated marketing
approval programs. More information on the FDA fast track program
is available at http://www.fda.gov/cber/inside/fastrk.htm "This
decision of the FDA underpins our confidence in phenoxodiol being
an effective therapy for late-stage prostate cancer. The next step
is to take phenoxodiol into a pivotal study where we will test its
ability to halt disease progression in men with prostate cancer who
have failed the standard treatment of hormone therapy and docetaxel
chemotherapy," said Dr. Graham Kelly, Executive Chairman of
Marshall Edwards, Inc. Mr. Christopher Naughton, CEO of Marshall
Edwards, Inc., said, "This decision represents a significant
endorsement of the potential of phenoxodiol, coming just 2 months
after the FDA granted fast track status for phenoxodiol for
late-stage ovarian cancer. The Company now has two opportunities to
pursue for the continuing development of phenoxodiol for the
benefit of both prostate cancer and ovarian cancer patients."
Phenoxodiol in intravenous form was granted fast track status by
the FDA in November 2004 for its intended use in patients with
recurrent ovarian cancer. About phenoxodiol Phenoxodiol is an
investigational product that regulates signal transduction pathways
in cancer cells resulting in the break down of the intra-cellular
proteins -- XIAP (X-linked Inhibitor of Apoptosis Protein) and FLIP
(Fas Ligand Inhibitory Protein) -- that block the ability of the
cancer cell to undergo apoptosis via the death receptor
mechanism.(1) While these proteins play a vital role in preventing
unintentional cell death in healthy cells, they are over-expressed
in many forms of cancer, as well as being associated with the
development of resistance to anti-cancer drugs.(2) Phenoxodiol
works selectively on tumor cells, thought to be due to its
interaction with the enzyme, tumor-specific NADH oxidase, which is
restricted to cancer cells. Clinical trials to date have revealed
no significant drug related adverse side effects. Phenoxodiol is an
investigational drug and, as such, is not approved for marketing in
the United States. About Prostate Cancer Prostate cancer is one of
the most common types of cancer among men in Western countries. The
American Cancer Society estimates there will be 232,000 new cases
of prostate cancer in the United States in 2005 and that about
30,350 men will die of this disease. Prostate cancer is strongly
associated with the male sex hormone, testosterone, and most early
cases of prostate cancer respond for some time to hormonal therapy
that blocks the ability of testosterone to stimulate the cancer.
However, the majority of cases of prostate cancer eventually become
independent of testosterone, at which time they are known as
hormone-refractory prostate cancer (HRPC). The cancer at this stage
typically is metastatic, with a patient survival time typically in
the range of 1 to 2 years. The FDA recently approved the
combination of docetaxel (Taxotere(R)) and prednisone for the
treatment of HRPC. That combination produced an overall increase in
survival of 10 weeks (from an average of 16.4 months to an average
of 18.9 months). About Novogen Limited and Marshall Edwards, Inc.
Phenoxodiol has been developed by Novogen Limited (NASDAQ:NVGN), an
Australian biopharmaceutical company that is specializing in the
development of therapeutics based on the diphenolic ring structure.
Novogen, based in Sydney, Australia, is developing a range of
therapeutics across the fields of oncology, cardiovascular disease
and inflammatory diseases. Marshall Edwards, Inc. has licensed from
Novogen Limited the rights to bring phenoxodiol to the global
market. 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
party 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. 1. Kamsteeg M et al., 2003.
Phenoxodiol -- an isoflavone analog -- induces apoptosis in
chemoresistant ovarian cancer cells. Oncogene 22:2611. 2. Cheng JQ
et al., 2002. Drug Resist Update 5, 131. DATASOURCE: Marshall
Edwards, Inc. CONTACT: USA: David Sheon, +1-202-518-6384, for
Marshall Edwards, Inc.; Australia: Dr. Graham Kelly, Chairman of
Marshall Edwards, Inc., +011 61 2 9878 0088 Web site:
http://www.marshalledwardsinc.com/ http://www.novogen.com/
http://tinyurl.com/5zeck http://www.fda.gov/cber/inside/fastrk.htm
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