Extended Accrual Time and Decreased Sample Size for OVATURE, a Multinational Phase III Clinical Study for Women With Recurrent O
May 09 2008 - 8:28AM
Marketwired
SYDNEY, AUSTRALIA and LONDON and NEW CANAAN, CT clinical study,
a Phase III study of the investigational chemosensitizing drug,
phenoxodiol, has been extended to facilitate complete patient
enrollment in the U.S., Europe, and Australia. Increasing the
accrual period allowed decreasing the total number of patients in
the study, without changing the required statistical analyses. As a
result, the OVATURE study will enroll 340 patients at 60 to 80
clinical sites throughout the United States, Europe, and Australia.
Initially, this study was announced to enroll 470 patients.
The primary outcome of the OVATURE trial is the assessment of
the relative time it takes for the ovarian cancer to progress. The
OVATURE trial design has been approved by the US Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA)
program, and 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 patient recruitment to this study is completed
and 95 patients have disease progression.
Phenoxodiol is being developed by the U.S. oncology company
Marshall Edwards, Inc. (NASDAQ: MSHL) as a novel therapeutic in
combination with carboplatin for late-stage chemoresistant ovarian
cancers, as well as a monotherapy for prostate and cervical
cancers. Phenoxodiol is an investigational novel-acting drug that
inhibits key pro-survival signaling pathways operating within
cancer cells causing selective cancer cell death and increased
susceptibility to drugs like platinum and taxane, to which most
ovarian cancer patients become resistant in late stage disease.
The OVATURE trial is a major multi-center multinational Phase
III clinical trial of orally-administered 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 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, more than 25 sites in the U.S., 20
sites in Europe/UK, and five sites in Australia are participating
in this clinical study.
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,
rendering those cells more sensitive to chemotherapy. 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 flavanoid 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, 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
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.
Contacts: David Sheon 202-470-2880 Email Contact Prof. Alan
Husband Mobile: + 011 61 418 607 804 Email Contact
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