Marshall Edwards Achieves Special Protocol Assessment and Agreement With FDA on Phase III (Ovature Study) of Phenoxodiol as a C
May 16 2006 - 9:57AM
PR Newswire (US)
WASHINGTON and SYDNEY, Australia, May 16 /PRNewswire/ --
Biotechnology company, Marshall Edwards, Inc., announced today that
under the Special Protocol Assessment (SPA) process, it has reached
agreement with the United States Food and Drug Administration (FDA)
on the design of a pivotal study protocol for its investigational
anti-cancer drug, phenoxodiol. The trial, known as the OVATURE
study, is designed to test the ability of phenoxodiol to restore
sensitivity of late-stage ovarian cancers to carboplatin, a
standard form of therapy for ovarian cancer. The SPA process allows
for FDA evaluation of a clinical trial protocol that will form the
basis of an efficacy claim for a marketing application, and
provides a binding agreement that the study design, including
patient numbers, clinical endpoints, and analyses are acceptable to
the FDA. Phenoxodiol received fast track designation for
platinum-resistant or refractory ovarian cancer from the FDA in
2004 based on Phase II data, and is eligible for FDA's programs
that are designed to facilitate drug development and expedite
marketing approval of drugs intended to treat serious or life-
threatening disease and to address unmet medical need. As a fast
track product, phenoxodiol will be eligible for accelerated
approval and priority review of the marketing application. "We are
pleased that the FDA has completed the SPA review process and that
we have a mutually-agreed design that provides us with a clearly
defined regulatory pathway for pursuing marketing approval of
phenoxodiol," said Professor Graham Kelly, Chairman, Marshall
Edwards, Inc. About Ovarian Cancer Treatment Platinum-based drugs
such as cisplatin and carboplatin are a standard form of
chemotherapy in ovarian cancer, with a high initial response rate.
However, at least 85-90% of these patients will experience disease
recurrence, subsequently showing a lower level of response to both
platinums and other chemotherapies. Most of these tumors ultimately
become resistant to platinums, and platinum-resistant tumors
invariably are resistant to other forms of chemotherapy. About
OVATURE Four hundred and seventy (470) patients are to be enrolled
and randomized to two treatment arms -- (i) carboplatin +
phenoxodiol, and (ii) carboplatin + placebo. The carboplatin will
be administered weekly intravenously, and the phenoxodiol or
placebo will be capsules administered 8-hourly on a continuous
daily basis. The trial will involve up to 60 sites in the United
States, the United Kingdom, Europe, and Australia. The primary
endpoint of the trial is progression-free survival, representing
death or disease progression, whichever comes first. Overall
survival is a secondary endpoint. Enrollment is not expected to
open for at least a month. More information about the study will be
available in due course at http://www.phenoxodiol.com/ or
http://www.clinicaltrials.gov/. These sites will contain
information on when and where the trial is open for enrollment.
About PHENOXODIOL Phenoxodiol is an investigational drug and, as
such, is not commercially available. Phenoxodiol is a novel-acting
drug that inhibits key pro-survival signaling pathways operating
via sphingosine-1-phosphate and Akt. Inhibition of these pathways
leads to prevention of phosphorylation of key anti-apoptotic
proteins such as XIAP. Loss of activity of these proteins restores
the ability of chemo-resistant tumor cells to undergo apoptosis in
response to chemotherapy. The putative molecular target for
phenoxodiol is a tumor- specific protein, accounting for the highly
selective nature of the drug. About Marshall Edwards, Inc. Marshall
Edwards, Inc. (NASDAQ:MSHL) has licensed rights from Novogen
Limited (NASDAQ:NVGN) to bring three oncology drugs -- phenoxodiol,
NV-196 and NV-143 -- to market globally. Marshall Edwards, Inc. is
majority owned by Novogen, an Australian biotechnology company that
is specializing in the development of therapeutics based on
regulation of the sphingomyelin pathway. 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 http://www.marshalledwardsinc.com/ and
http://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
arty 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. DATASOURCE: Marshall Edwards, Inc.
CONTACT: Professor Graham Kelly, Chairman of Marshall Edwards,
+1-203-247-1322; or David Sheon of SciWords, LLC, +1-202-518-6321,
for Marshall Edwards Web site: http://www.marshalledwardsinc.com/
http://www.novogen.com/ http://www.phenoxodiol.com/
http://www.clinicaltrials.gov/
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