A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug Phenoxodiol
August 30 2007 - 8:30AM
PR Newswire (US)
OVATUREtrial.com Launched to Inform Patients with Recurrent Ovarian
Cancer about the OVATURE Clinical Research Study NEW CANAAN, Conn.,
Aug. 30 /PRNewswire-FirstCall/ -- A new website has been launched
to facilitate recruitment of patients to OVATURE (OVArian TUmor
REsponse), a Phase III clinical trial of an investigational ovarian
cancer drug phenoxodiol. The goal of http://www.ovaturetrial.com/
is to inform ovarian cancer patients about the OVATURE trial, which
is actively recruiting patients, and to provide more information
about the trial and the investigational drug phenoxodiol. Visitors
to the site will find information about the trial including
eligibility, trial locations and participating doctors. Hospitals
and treatment centers throughout the United States, Europe and
Australia are serving as trial sites, and
http://www.ovaturetrial.com/ will guide patients to site locations
as they begin recruiting. Ovarian cancer patients whose cancer
initially responded to chemotherapy, but has since become resistant
or refractory to traditional platinum treatments are eligible to
participate. In the U.S. 30 sites are planned and the current trial
locations include Yale University School of Medicine in New Haven,
Connecticut; the Women's Cancer Center of Nevada in Las Vegas,
Nevada; the University of Texas Southwestern Medical Center at
Dallas in Dallas, Texas; Providence Hospital and Medical Centers in
Southfield, Michigan; Hematology Oncology in Stamford, Connecticut;
Gabrail Cancer Center in Canton, Ohio; Northern Virginia Pelvic
Surgery Associates in Annandale, Virginia; and Chattanooga GYN
Oncology in Chattanooga, Tennessee. In Australia, the current trial
locations include Prince of Wales Hospital and Westmead Hospital in
Sydney; Royal Adelaide Hospital, in Adelaide; and Mater Adult
Hospital in Brisbane. In Europe, 26 sites are planned and
recruitment has commenced at UZ Leuven Gynaecological Oncology in
Leuven, Belgium. The trial is studying the safety and effectiveness
of the drug phenoxodiol, which has not yet been approved for
marketing by the FDA, when used in combination with weekly doses of
the chemotherapy drug, carboplatin. The trial will consist 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 randomized. A change
from receiving carboplatin (or cisplatin) every two to three weeks
to a weekly carboplatin regimen has been reported to provide a
tumor response in some patients with recurrent ovarian cancer.(1)
In addition to learning more about the safety and efficacy of
phenoxodiol, researchers will learn more about the efficacy of
weekly carboplatin. In laboratory studies using animal models of
cancer and human cell lines, phenoxodiol was shown to reverse
chemoresistance to standard chemotherapies, including platinum
drugs, taxanes, gemcitabine, topotecan and doxorubicin. The ability
of phenoxodiol to reverse multi-drug resistance is thought to be
due to its disruption of several key targets specific to tumor cell
biochemistry. In a prior Phase II clinical trial, phenoxodiol was
tested in combination with either cisplatin or paclitaxel. Twenty
one patients with late stage ovarian cancer that had become
refractory to platinum (cisplatin or carboplatin) and 19 patients
that had become resistant to paclitaxel therapy, following multiple
courses of chemotherapy, were treated with phenoxodiol and
cisplatin or phenoxodiol and paclitaxel, respectively. The
cisplatin (40 mg/m2) or paclitaxel (80 mg/m2) was administered
weekly, and phenoxodiol was administered by intravenous infusion at
3 mg/kg on two consecutive days immediately prior to the cisplatin
administration. Treatment was for six weeks and was continued until
dose limiting toxicity or disease progression. In this trial, as
measured using the RECIST criteria, in the cisplatin arm there were
six partial responders, nine patients with stabilized disease and
six patients who had disease progression; in the paclitaxel arm,
there was one complete responder, two partial responders, eleven
with stabilized disease and five patients who had disease
progression. For more information about RECIST, visit
http://www.recist.com/. There were few side effects associated with
phenoxodiol, but, as with any investigational drug, there is a
possibility of unexpected side effects. 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/.
(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.
About Phenoxodiol Phenoxodiol is believed to help chemotherapy
drugs, such as carboplatin, kill chemoresistant cancer cells by
removing factors in the cells that block the killing action of
chemotherapy. Phenoxodiol appears to selectively inhibit the
pro-survival regulator in cancer cells known as S-1-P
(sphingosine-1-phosphate) that is over expressed in cancer. In
response to Phenoxodiol, the S-1-P content in cancer cells is
decreased rendering those cells more sensitive to chemotherapy.
Indeed, in laboratory studies, it has been demonstrated that cancer
cells pre-treated with phenoxodiol were killed with lower doses of
chemotherapy drugs. Importantly, phenoxodiol has been shown not to
adversely affect normal cells in animal and laboratory testing.
Phenoxodiol is being investigated as a therapy for late-stage,
chemoresistant ovarian, prostate and cervical cancers. Phenoxodiol
has received Fast Track status from the FDA to facilitate
development as a therapy for recurrent ovarian and prostrate
cancers. Phenoxodiol is an investigational drug and, as such, is
not commercially available. Under U.S. law, a new drug cannot be
marketed until it has been investigated in clinical trials and
approved by FDA as being safe and effective for the intended use.
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
characterized 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
(NASDAQ: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 specializing 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 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. DATASOURCE: Marshall Edwards
Inc. CONTACT: David Sheon, +1-202-518-6321, , or Warren Lancaster,
+1-203-966-2556, , both for Marshall Edwards Inc. Web site:
http://www.marshalledwardsinc.com/ http://www.novogen.com/
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