Marshall Edwards, Inc., to Undertake Analysis of Ovature Trial
April 14 2009 - 8:20AM
Marketwired
Marshall Edwards, Inc., (NASDAQ: MSHL) today announced that it will
be undertaking an un-blinded analysis of the data from its Phase
III international, multicenter clinical study known as "Ovature"
(OVArian TUmor REsponse).
Subject to ethical and regulatory approvals, patients currently
enrolled in the trial will continue their treatment according to
the study protocol. However, new patient recruitment into the
Ovature study will cease and the available data from the 141
completed and current patients will be analyzed for safety and
efficacy outcomes. As noted by the Independent Data Monitoring
Committee in its last review, there have been no significant safety
concerns raised to date. Data analysis for the primary endpoint,
progression free survival, is expected to be completed within three
months. Per the study protocol, the secondary endpoint, overall
survival, cannot be analyzed until 18 months after the last patient
was randomized, or sooner if there are no patients surviving.
The Company has decided to assess these data from the Ovature
trial at this time, as the current downturn in the global financial
markets makes raising further equity or debt in the near term to
fund the trial through to completion most unlikely. According to
the agreement reached with the FDA in a Special Protocol
Assessment, the planned interim analysis of the data can be
scheduled only after 95 events of disease progression and full
recruitment of 340 patients. However, changes in standards of care
over the period the trial has been in operation and the specific
inclusion/exclusion criteria of the Ovature protocol have slowed
patient recruitment rates and, consequently, the Company has deemed
it prudent not to fund the trial to completion.
"The determination to conduct an un-blinded analysis of the
Ovature data has been taken to assess the clinical and
commercialization opportunities available for phenoxodiol and to
enable the continuing funding from current resources of the ongoing
Phase I and II programs and release funds to in-license promising
and available compounds," said Christopher Naughton, President and
CEO of Marshall Edwards, Inc. "We believe that this oncology
focused multi-phase program will maximize opportunities in the best
interests of shareholders and patients and enhance the value of the
Company's proprietary flavonoid technology platform over the medium
term."
Accordingly, the Company intends to allocate its current funds
of approximately $23 million to completing the Ovature data
analysis of 141 patients, pursuing negotiations for out-licensing
phenoxodiol should evidence of efficacy and safety emerge from the
Ovature analysis, maintaining other ongoing phenoxodiol ovarian and
prostate cancer clinical trials, initiating the triphendiol
clinical program, and to in-license further promising anti-cancer
compounds:
-- A Phase Ib/IIa study of phenoxodiol in combination with the Sanofi-
Aventis drug Docetaxel (Taxotere�) in ovarian cancer is continuing at the
Yale University School of Medicine;
-- Also at Yale, the Phase II clinical trial of phenoxodiol comparing its
safety and efficacy in patients with early stage and advanced prostate
cancer is ongoing;
-- Marshall Edwards also has the drug candidate triphendiol (NV-196), for
which an Investigational New Drug Application (IND) has been granted by the
FDA, allowing clinical trials to commence in the US for pancreatic and bile
duct cancers. In addition, this drug was designated by the FDA as an Orphan
Drug for treatment of pancreatic cancer, bile duct cancer, and late stage
melanoma;
-- Marshall Edwards is currently in advanced negotiations with Novogen
Limited to in-licence the mTOR inhibitor NV-128, which has shown compelling
preclinical results to date.
"The scientific and commercial excitement around the potential
of mTOR inhibitors, and particularly this stand-out compound with
dual mTORC1 and mTORC2 inhibition, has made NV-128 a high priority
for the Marshall Edwards drug development program," said Professor
Bryan Williams, the Chairman of Marshall Edwards, Inc. "We expect
to add NV-128 to our portfolio by obtaining oncology
commercialization rights and to move ahead quickly with the
clinical program."
About Ovature
The Ovature study is a multi-center international Phase III
clinical trial of the orally-administered investigational drug
phenoxodiol 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.
About Marshall Edwards, Inc. and Novogen Limited
Marshall Edwards, Inc., is a specialist oncology company focused
on the clinical development of novel anti-cancer therapeutics.
These derive from a flavonoid technology platform that has
generated a number of novel compounds characterized by broad
ranging activity in laboratory testing against a range of cancer
targets with few side effects. The ability of these compounds to
target an enzyme present on the surface of cancer cells, and
inhibit the production of pro-survival proteins within the cancer
cell suggests that they may possess a unique combination of
efficacy and safety. Marshall Edwards, Inc., has licensed rights
from Novogen Limited (ASX: NRT) (NASDAQ: NVGN) to bring three
oncology drugs -- phenoxodiol, triphendiol and NV-143 -- to market
globally. Marshall Edwards, Inc., is majority owned by Novogen
Limited, an Australian biotechnology company that is specializing
in the development of therapeutics based on a flavonoid technology
platform. 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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CONTACTS: Christopher Naughton 011 612 9878-0088 (Australia)
Email Contact David Sheon 202 547-2880 Email Contact
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