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.
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.
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Contact: Warren Lancaster +1-203-966-2556 (USA) Email Contact
Alan Husband +011 61 2 9878 0088 (Australia) Email Contact
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