Contact Information: Contact: Warren Lancaster +1-203-966-2556 (USA) Alan Husband +61 2 9878 0088 (Australia)
Marshall Edwards, Inc. Files IND Application for Triphendiol
| Source: Marshall Edwards, Inc.
NEW CANAAN, CT--(Marketwire - December 1, 2008) - Marshall Edwards, Inc. (NASDAQ : MSHL ) today
announced that it has filed an application with the United States Food and
Drug Administration for an Investigative New Drug (IND) approval to
undertake clinical studies with triphendiol as a chemosensitizing agent in
combination with gemcitabine. The IND application is to enable a Phase Ib
study of triphendiol in combination with gemcitabine in patients with
unresectable, locally advanced or metastatic pancreatic and bile duct
cancers.
About Triphendiol:
Triphendiol (NV-196) is an investigational drug in the Marshall Edwards,
Inc., oncology drug pipeline, currently being developed as an
orally-delivered chemosensitizing agent, intended for use in conjunction
with standard chemotoxic anti-cancer drugs for the treatment of late stage
pancreatic cancer, cholangiocarcinoma, and melanoma. Triphendiol was
granted orphan drug status by the U.S. Food and Drug Administration for
pancreatic cancer and cholangiocarcinoma in January 2008 and for treatment
of stage IIb-IV malignant melanoma in February 2008.
Triphendiol is broadly cytostatic and cytotoxic against most forms of human
cancer cells in vitro, and has been shown to cause cell cycle arrest (or
stop cells increasing in number) and to induce apoptosis (or initiate
programmed cell death) in various cancer cell lines. Biological studies
suggest a mechanism of cytotoxicity that involves mitochondrial
depolarization and downregulation of XIAP. It exhibits high selectivity,
little effect on non-tumor cells and no observable toxicity in animals at
therapeutically effective doses. In human studies conducted in Australia,
no adverse events or side effects have been reported when administered to
volunteers.
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 (ASX : NRT ) (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 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.