Marshall Edwards, Inc. (NASDAQ: MSHL), an oncology company focused
on the clinical development of novel anti-cancer therapeutics,
announced today that a final analysis of its Phase 3 OVATURE trial
of orally administered phenoxodiol in women with recurrent ovarian
cancer determined that the trial did not show a statistically
significant improvement in its primary (progression-free survival)
or secondary (overall survival) endpoints. As previously announced,
the trial was closed for recruitment before completion of enrolment
with only 142 out of a planned 340 patients enrolled.
This multi-center, randomized, double-blind trial assessed the
safety and efficacy of daily phenoxodiol in combination with weekly
carboplatin versus weekly carboplatin with placebo in patients with
platinum-resistant or platinum-refractory, late-stage epithelial
ovarian, fallopian or primary peritoneal cancer following at least
second line platinum therapy.
"Owing to the fact that this trial was significantly
underpowered due to the small number of patients enrolled, we were
disappointed, but not entirely surprised by the final outcome,"
said Dr. Daniel P. Gold, newly appointed Chief Executive Officer of
Marshall Edwards. "However, we remain confident that our
investigational isoflavone platform, including triphendiol, a
potentially more potent, second-generation analogue of phenoxodiol,
may be of benefit to women with ovarian cancer, particularly when
administered intravenously.
"Previously reported results of a Phase 2 trial," continued Dr.
Gold, "which tested the activity of intravenous phenoxodiol plus
weekly cisplatin in a similar platinum-resistant or refractory
patient population, demonstrated a 30% response rate (6 out of 20)
compared to less than 1% (1 out of 142) in the OVATURE study in
which phenoxodiol was administered orally. In addition, we remain
excited with the progress of another product candidate in our
pipeline, NV-128, a novel isoflavone analogue with a mode of action
distinct from both phenoxodiol and triphendiol.
"Lastly, I want to take this opportunity to personally thank the
patients and their families for their participation in this trial.
I would also like to thank the clinical investigators and trial
coordinators for their dedication and support."
Safety Outcomes
As previously noted, phenoxodiol had a good safety profile and
was well tolerated. The number of patients experiencing at least
one adverse event was similar in each treatment group, as was the
number of patients experiencing adverse events of Grade 3 or
higher.
About OVATURE and the Phenoxodiol Clinical
Program
The OVATURE ("OVArian TUmor REsponse") trial was a
multi-center international Phase 3 clinical trial of orally
administered investigational drug phenoxodiol in combination with
carboplatin in women with advanced ovarian cancer resistant or
refractory to platinum-based drugs to determine its safety and
effectiveness when used in combination with carboplatin.
The trial recruited ovarian cancer patients whose cancer
initially responded to chemotherapy, but had since become resistant
or refractory to traditional platinum treatments. The study was
closed to enrolment in April 2009 at which time 142 patients had
been randomized to the study. Changes in standards of care over the
period of the trial and the stringency of inclusion/exclusion
criteria of the OVATURE protocol had slowed patient recruitment
rates and consequently the Company deemed it prudent not to
continue the trial to completion. The Independent Data Monitoring
Committee (IDMC) supported the Company's decision to close the
study to accrual, and, in a review of the available safety data,
the IDMC confirmed that there were no safety concerns with
phenoxodiol in these subjects.
About Phenoxodiol
Phenoxodiol is being developed as a chemosensitizing agent in
combination with platinum drugs for late stage, chemoresistant
ovarian cancer and as a monotherapy for prostate and cervical
cancers. It is believed to have a unique mechanism of action,
binding to cancer cells via a cell membrane oxidase, causing major
downstream disturbances in expression of proteins necessary for
cancer cell survival and responsible for the development of drug
resistance.
Phenoxodiol appears to selectively inhibit the regulator known
as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer
cells. In response to phenoxodiol, S-1-P content is decreased, with
a consequent decrease in expression of the pro-survival proteins
XIAP and FLIP, inducing cell death via caspase expression and
promoting sensitivity to other chemotherapeutics. In laboratory
studies, it has been demonstrated that drug-resistant ovarian
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 has been granted Fast Track status from the FDA to
facilitate its development as a therapy for recurrent ovarian and
prostate cancers. Fast Track designation is designed to facilitate
the review of products that address serious or potentially
life-threatening conditions for which there is an unmet medical
need and provides the option to file a New Drug Application on a
rolling basis. This permits the FDA to review the filing as it is
received, expediting the review process. 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 an investigational isoflavone
technology platform, which has generated a number of novel
compounds characterized by broad ranging activity against a range
of cancer cell types with few side effects. The combination of
anti-tumor cell activity and low toxicity is believed to be a
result of the ability of these compounds to target an enzyme
present in the cell membrane of cancer cells, thereby inhibiting
the production of pro-survival proteins within the cell. Marshall
Edwards has licensed rights from Novogen Limited (ASX: NRT)
(NASDAQ: NVGN) to bring oncology drugs phenoxodiol, triphendiol and
NV-128 to market globally.
Marshall Edwards is majority owned by Novogen Limited, an
Australian biotechnology company that is specializing in the
development of therapeutics based on an isoflavone technology
platform. Novogen is developing a range of therapeutics across the
fields of oncology, cardiovascular disease and inflammatory
diseases. More information on Marshall Edwards 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 or differences in interpretation 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.
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CONTACTS: Warren Lancaster +1-203-966-2556 (USA) Email Contact
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