Early Analysis Enables Extension of Current Resources to Additional Programs
NEW CANAAN, CT and SYDNEY, AUSTRALIA -- (Marketwire) -- 04/14/09 -- 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.
