NEW CANAAN, CT and SYDNEY, AUSTRALIA--(Marketwire - April 14, 2009) - 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.
Contact Information: CONTACTS:
Christopher Naughton
011 612 9878-0088 (Australia)
David Sheon
202 547-2880