Information  X 
Enter a valid email address

Marshall Edwards (MSH)

  Print      Mail a friend

Wednesday 26 January, 2005

Marshall Edwards

FDA grants second fast track

Marshall Edwards, Inc.
26 January 2005

Marshall Edwards, Inc.





CONTACT:  David Sheon 202 518-6384 USA for Marshall Edwards, Inc.
          Dr. Graham Kelly 011 61 2 9878 0088 Australia Chairman of Marshall 
          Edwards, Inc.



FOR IMMEDIATE RELEASE



FDA grants fast track designation for phenoxodiol in oral dosage form for
Prostate Cancer

(Washington, DC - January 26, 2005) 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, 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 www.marshalledwardsinc.com and
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.

                                      ###




                      This information is provided by RNS
            The company news service from the London Stock Exchange                                                                                                                                                                                                                 

a d v e r t i s e m e n t