ASX
& MEDIA RELEASE
13
NOVEMBER, 2008
INDEPENDENT
DATA MONITORING COMMITTEE RECOMMENDS MARSHALL EDWARDS, INC.’S OVATURE TRIAL
CONTINUE
Novogen
Limited’s U.S. subsidiary, Marshall Edwards, Inc. (Nasdaq: MSHL) has just made
the following announcement:
New
Canaan, CT, 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 remains 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 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
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
.
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.
More
information on the Novogen group of companies can be found at
www.novogen.com.