Marshall Edwards, Inc. Files IND Application for Triphendiol
December 01 2008 - 8:10AM
Marketwired
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.
Contact: Warren Lancaster +1-203-966-2556 (USA) Email Contact
Alan Husband +61 2 9878 0088 (Australia) Email Contact
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