FDA Grants Marshall Edwards, Inc. Fast-Track Designation for Phenoxodiol for Recurrent Ovarian Cancer
November 04 2004 - 9:28AM
PR Newswire (US)
FDA Grants Marshall Edwards, Inc. Fast-Track Designation for
Phenoxodiol for Recurrent Ovarian Cancer WASHINGTON, Nov. 4
/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 recurrent ovarian cancer. In approving phenoxodiol
for fast track status, the letter from FDA stated: "We are granting
fast track designation for the following reasons: 1. Recurrent
ovarian cancer that is resistant or refractory to platins and
taxanes is a life-threatening condition 2. Phenoxodiol intravenous
demonstrates potential to address an unmet medical need by
restoring chemo-sensitivity in resistant/refractory ovarian
cancer." The Fast Track application submitted to the FDA contained
clinical data including tumor measurements based on radiographic
examination. The data are from the current Phase Ib/IIa study where
patients with recurrent ovarian and primary peritoneal cancers are
receiving phenoxodiol (intravenous dosage form) in combination with
paclitaxel in those patients where the cancer is refractory or
resistant to taxanes, or in combination with cisplatin where the
cancer is refractory or resistant to platinum-based drugs. 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 "We are developing
phenoxodiol for the treatment of a wide range of cancers, but for
the purpose of this Fast Track Program, we are focusing on its use
as a chemo-sensitizing agent in recurrent, late-stage ovarian
cancer," said Dr. Graham Kelly, Executive Chairman of Marshall
Edwards, Inc. "Ovarian cancer is one of the most devastating forms
of cancer, with half of the women diagnosed with it dying within
five years," Dr. Kelly said. "The FDA's decision to accept
phenoxodiol into its Fast Track Program reflects the dire need to
provide help for women with this deadly disease once they become
resistant to standard anti-cancer drugs." Mr. Christopher Naughton,
CEO of Marshall Edwards, Inc., said, "Our goal is to continue the
development of phenoxodiol as rapidly as possible for the benefit
of ovarian cancer patients. We look forward to working closely with
the FDA as we continue the development of phenoxodiol for this and
all other indications under development." 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) --
which 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) Pre-clinical studies have shown that by targeting these
anti-apoptotic proteins, phenoxodiol is able to promote death of
ovarian cancer cells that are highly resistant to standard
anti-cancer drugs, as well as being able to restore sensitivity in
these cells to standard anti-cancer drugs such as taxanes.(3)
Phenoxodiol works selectively on tumor cells because of its
interaction with the 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 Ovarian Cancer Ovarian cancer is the most
lethal gynecological malignancy, and the fourth leading cause of
cancer related death in women in the United States. The American
Cancer Society reports that an estimated 25,580 new cases of
ovarian cancer will be diagnosed each year in the United States and
16,090 deaths will occur. The lifetime probability of a woman
developing ovarian cancer is 1 in 59. The high mortality is due
mainly to the inability to detect early disease, with approximately
80 percent of patients being diagnosed in advanced-staged disease.
However, even in those patients diagnosed with Stage I or Stage II
disease, the five-year survival rate ranges from 60 to 90 percent
depending on the degree of tumor differentiation. Despite treatment
advances over the past decade, there has been no advance in overall
survival. The reason for this is the high rate of relapse. Of
patients who respond to first-line chemotherapy, less than 10 to 15
percent of these will remain in remission, and most relapsed cases
are chemo-resistant. The failure of some ovarian cancers to respond
to first-line chemotherapy and the development of resistance to
multi-drug therapies represent the major hurdles to effective
therapy of ovarian cancer. About the current study The current
Phase Ib/IIa study is an open label, randomized study being
conducted at two sites (Yale-New Haven Hospital, New Haven, CT,
USA, and Royal Women's Hospital, Melbourne, VIC, Australia) and
involving women with recurrent ovarian cancer that is either
resistant or refractory to taxane- and/or platinum-based drugs. The
definition of 'resistant' is disease progression within six months
of commencement of drug therapy, and 'refractory' is disease
progression while undergoing drug therapy. Patients are being
randomized to one of three treatment groups -- (i) phenoxodiol +
cisplatin, (ii) phenoxodiol + paclitaxel, and (iii) paclitaxel
only, converting to phenoxodiol + paclitaxel after disease
progression has been demonstrated. Phenoxodiol is administered by
intravenous infusion on two consecutive days per week and the
second drug administered intravenously immediately following the
second phenoxodiol administration. Treatment is weekly on a
continuous basis until either disease progression or complete
response as determined by the absence of detectable disease. There
are 20 subjects per treatment group. Phenoxodiol is being
administered at a dosage of 3 mg/kg; the dosages of paclitaxel and
cisplatin are standard but adjustable to ensure that toxicity is no
greater than Grade 1,(4) being the least toxic grade. 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 isoflavonoid 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. 3. Sapi E et
al., 2004. Resistance of ovarian carcinoma cells to (Taxotere)
docetaxel is XIAP dependent and reversible by phenoxodiol. Oncology
Research (In Press) 4. National Cancer Institute Common Toxicity
Criteria (CTC version 2) DATASOURCE: Marshall Edwards, Inc.
CONTACT: Australia: Christopher Naughton of Marshall Edwards, Inc.,
+011 61 2 9878 0088; or David Sheon, office: +1-202-518-6384, cell:
+1-202-422-6999, for Marshall Edwards, Inc. Web site:
http://www.marshalledwardsinc.com/ http://www.novogen.com/
http://www.fda.gov/cber/inside/fastrk.htm
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