First Patient Enrolled in Europe in Ovature Phase III Ovarian Cancer Trial
August 27 2007 - 9:28AM
PR Newswire (US)
Novogen Limited's subsidiary, Marshall Edwards Inc. (Nasdaq: MSHL),
has made the following announcement: SYDNEY, Australia and NEW
CANAAN, Conn., Aug. 27 /PRNewswire-FirstCall/ -- Marshall Edwards,
Inc. (NASDAQ:MSHL) today announced enrolment of the first patient
in Europe in the Phase III Ovature clinical trial of phenoxodiol in
women with advanced ovarian cancer resistant or refractory to
platinum-based drugs. The first patient to commence on the study at
an Ovature site in the EU has been enrolled at the Catholic
University of Leuven, Belgium, under the direction of Professor
Ignace Vergote, Head of Gynaecologic Oncology. "We are hopeful that
a positive outcome of this multi-centre study will be a significant
medical advance for thousands of women with late stage ovarian
cancer whose tumours have become insensitive to the existing
chemotherapeutic drugs," Professor Vergote said. "As one of
Europe's largest cancer institutions, it is important for us to be
a part of these worldwide studies. It is important that we continue
to develop new ovarian cancer treatments. It is only through
constant research that we will learn how to battle this deadly
disease effectively," said Professor Vergote. The Catholic
University of Leuven is one of 26 sites in UK and Europe which will
be recruiting patients into this major multi-centre multinational
ovarian cancer study to determine the safety and effectiveness of
the drug phenoxodiol, when used in combination with the
chemotherapy drug, carboplatin. Ovarian cancer patients whose
cancer initially responded to chemotherapy, but has since become
resistant or refractory to traditional platinum treatments are
eligible to participate. There will be an additional 30 sites in
the USA, of which 7 are now recruiting patients, and there are 4
sites open in Australia. The total number of patients to be treated
in this pivotal study is 470. The trial consists of two double
blind treatment arms. Patients in one trial arm will receive weekly
carboplatin and phenoxodiol. Patients in the other trial arm will
also receive weekly carboplatin, but a placebo will be substituted
for phenoxodiol. Neither patients, nor their doctors will know to
which trial arm the patients are randomised. A change from
receiving carboplatin (or cisplatin) in the traditional dose
pattern (every two to three weeks) to a weekly carboplatin regimen
has been reported to provide a tumour response in some patients
with recurrent ovarian cancer(1-3). Thus in addition to learning
more about the safety and efficacy of phenoxodiol, researchers will
learn more about the efficacy of weekly carboplatin. The primary
outcome of the trial is the assessment of the relative time it
takes for the ovarian cancer to progress. An analysis of interim
results will be possible after 95 patients have progressed with
their disease. The trial is being run under arrangements approved
by the US Food and Drug Administration (FDA) known as a Special
Protocol Assessment (SPA). This provides for the interim analysis
of the data, which, if significant, can be used to support a
request for grant of marketing approval. The Chief Executive
Officer of Marshall Edwards, Inc., Mr. Christopher Naughton, said
the Phase III Ovature study was a significant milestone for the
Company. "Over the next 12 to 18 months we expect the interim
results from this multi-national clinical trial which may lead to
the first approval for phenoxodiol," Mr. Naughton said. In a prior
Phase II clinical trial, phenoxodiol was tested in combination with
either cisplatin or paclitaxel. Patients with late stage ovarian
cancer that had become refractory to platinum or paclitaxel
therapy, following multiple courses of chemotherapy, were treated
with phenoxodiol and cisplatin or phenoxodiol and paclitaxel,
respectively. Of 21 patients in the cisplatin arm there were six
partial responders, nine patients with stabilised disease and six
patients who had disease progression; of 19 in the paclitaxel arm,
there was one complete responder, two partial responders, eleven
with stabilised disease and five patients who had disease
progression. There were few side effects associated with
phenoxodiol, but, as with any investigational drug, there is a
possibility of unexpected side effects. Professor Ignace Vergote,
the Principal Investigator at the Leuven site was Chairman of the
EORTC Gynaecologic Cancer Group from 1997 to 2003, and still chairs
the Protocol Committee of that group. He is currently the President
of the International Cancer Society and Immediate Past-President of
the European Society of Gynaecologic Oncology. Women who are
interested in participating in the OVATURE trial, or who simply
wish to learn more about this study, should visit
http://www.ovaturetrial.com/ or visit http://clinicaltrials.gov/
(type OVATURE in the search box). About phenoxodiol: Phenoxodiol is
being developed as a therapy for late- stage, chemo-resistant
prostate, ovarian and cervical cancers. Phenoxodiol is an
investigational drug and, as such, is not commercially available.
It is a novel-acting drug that inhibits key pro-survival signalling
pathways operating via sphingosine-1-phosphate and Akt. Inhibition
of these pathways leads to prevention of phosphorylation of key
anti-apoptotic proteins such as XIAP. Loss of activity of these
proteins restores the ability of chemoresistant tumour cells to
undergo apoptosis in response to chemotherapy. The putative
molecular target for phenoxodiol is a tumour-specific protein,
accounting for the highly selective nature of the drug. About
Marshall Edwards, Inc.: Marshall Edwards, Inc. (NASDAQ:MSHL) is a
specialist oncology company focused on the clinical development of
novel anti- cancer therapeutics. These derive from a flavonoid
technology platform which has generated a number of novel compounds
characterised by broad ranging efficacy against a range of cancer
targets with few side effects. The unique combination of efficacy
and safety has been explained by their ability to target an enzyme
present on the surface of cancer cells, thereby inhibiting the
production of pro-survival proteins within the cell. Marshall
Edwards, Inc., has licensed rights from Novogen Limited
(ASX:NovogenASX:-ASX:Nasdaq:ASX:NVGN) to bring three oncology drugs
- phenoxodiol, NV-196 and NV-143 - to market globally. Marshall
Edwards, Inc., is majority owned by Novogen, an Australian
biotechnology company that is specialising in the development of
therapeutics based on a flavonoid technology platform. Novogen,
based in Sydney, Australia, is developing a range of therapeutics
across the fields of oncology, cardiovascular disease and
inflammatory diseases. More information on phenoxodiol and on the
Novogen group of companies can be found at and
http://www.novogen.com/ . (1) Piura B and Meirovitz M. Weekly
single-agent carboplatin in heavily pretreated patients with
recurrent ovarian, peritoneal and fallopian tube carcinoma. Eur J
Gynaecol Oncol. 2005;26(4):386-90. (2) van der Burg ME, van der
Gaast A, Vergote I, Burger CW, van Doorn HC, de Wit R, Stoter G,
Verweij J. What is the role of dose-dense therapy? Int J Gynecol
Cancer. 2005 Nov-Dec;15 Suppl 3:233-240. (3) CaDron I, Leunen K,
Amant F, Van Grop T, Neven P, Vergote I. The "Leuven" dose dense
paclitaxel/carboplatin regimen in patients with recurrent ovarian
cancer. Gynecol Oncol 2007, in press. 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: Novogen Limited CONTACT:
Professor Alan Hisband, Research Director of Novogen Limited,
(02)-9878-0088; or David Reid of Westbrook Communications,
(02)-9231-0922 or 0417-217-157, for Novogen Limited Web site:
http://www.novogen.com/ http://www.ovaturetrial.com/
http://clinicaltrials.gov/ http://www.marshalledwardsinc.com/
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