NEW CANAAN, CT--(Marketwire - November 12, 2008) - The Independent Data Monitoring Committee
(IDMC) constituted to oversee the conduct of the Phase III OVArian TUmor
REsponse (OVATURE) Trial, yesterday recommended continuation of the study.
The OVATURE trial is a major multi-center international Phase III 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 IDMC is responsible to ensure that patients recruited to the study are
not exposed to unnecessary safety risks, that the study continues to meet
its clinical objectives, that it is run according to the required standards
of Good Clinical Practice, and that recruitment progress is satisfactory.
Following yesterday's review of recruitment progress, as well as safety and
efficacy data, the Committee has recommended that the study remain open and
continue as planned towards its accrual target of 340 patients.
"We are extremely pleased with this outcome and the recommendation of the
Independent Data Monitoring Committee to continue the study," said
Professor Husband, Group Director of Research.
"We are pleased to report that at the time of the Committee meeting, 78
patients had completed on the study, and a substantial data set was made
available for review. While site recruitment was slower than expected in
the early stages of the study, we now have 75 sites involved and the pace
of recruitment has increased significantly. We will continue to apply all
possible strategies to ensure the study continues towards its interim and
final analysis endpoints," Professor Husband said.
The OVATURE trial is recruiting ovarian cancer patients whose cancer
initially responded to chemotherapy, but has since become resistant or
refractory to traditional platinum treatments. Patients are being
recruited at clinical sites across the USA, UK, Europe and Australia.
Currently, 75 sites are participating in this study, 39 sites in the U.S.,
30 in Europe/UK, 6 sites in Australia, and additional sites may be opened
as the opportunity arises.
The OVATURE trial has been approved by the U.S. Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) program,
indicating that the study's design, clinical endpoints, and statistical
analyses are acceptable to the FDA. The protocol provides for an interim
analysis of the data, which, if statistically significant, can be used to
support a request for accelerated marketing approval. An analysis of
interim results will be possible after the targeted patient recruitment to
this study is completed and 95 patients have disease progression. The
OVATURE trial is sponsored by Marshall Edwards, Inc. (NASDAQ: MSHL), the
developer of phenoxodiol.
Patients and caregivers who are interested in learning more about the
OVATURE trial should visit a website for this study at
www.OVATUREtrial.com.
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 has 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.
In cancer cells, 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, the S-1-P content in cancer cells is
decreased, with a consequent decrease in expression of the pro-survival
proteins XIAP and FLIP, inducing cancer cell death via caspase expression
and promoting sensitivity to other chemotherapeutics. Indeed, 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 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 its development as a
therapy for recurrent ovarian and prostate 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.
Phenoxodiol is the first of a family of compounds in the Marshall Edwards,
Inc. drug pipeline of flavonoid derivatives.
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 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, Inc. has licensed rights from Novogen
Limited (NASDAQ: NVGN) to bring three oncology drugs -- phenoxodiol,
triphendiol and NV-143 -- to market globally. The Company's lead
investigational drug, phenoxodiol, is in a Phase III multinational
multi-centered clinical trial for patients with recurrent ovarian cancer.
More information on the trial can be found at http://www.OVATUREtrial.com.
Marshall Edwards, Inc. is majority owned by Novogen (ASX: NRT) (NASDAQ: NVGN), an Australian biotechnology company that is specializing in the
development of therapeutics based on a flavonoid technology platform.
Novogen 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 www.marshalledwardsinc.com and www.novogen.com.
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investigated in clinical trials and approved by the FDA as being safe and
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