Glycotex, Inc. Obtains Active IND From US Food and Drug Administration for GLYC-101 Wound Healing Compound
January 07 2008 - 6:57PM
Marketwired
ROCKVILLE, MD from the US Food and Drug Administration (FDA) for
the start of a phase IIa clinical trial of its lead product
candidate GLYC-101, administered topically for the treatment of
burn wounds.
The phase IIa human clinical trial to be conducted in the US is
a randomized double-blind, placebo controlled clinical trial
designed to investigate the safety and clinical outcomes of
topically applied GLYC-101 compared to placebo in subjects
undergoing carbon dioxide laser skin resurfacing.
GLYC-101 has already completed a phase II human clinical trial
in Australia for the treatment of chronic venous skin ulcers.
Glycotex, Inc. intends to develop GLYC-101 for a wide range of
human wound healing and tissue repair applications including burn
wounds, post surgical wounds, diabetic ulcers and chronic venous
ulcers.
About Glycotex, Inc:
Glycotex, Inc. is a US-based development stage biopharmaceutical
company focused on discovering and developing therapies intended to
accelerate human wound healing and tissue repair across a wide
range of human applications. It has licensed from Novogen certain
patent rights and knowhow to use and exploit its technology in a
wide range of wound healing applications.
Glycotex, Inc. is an 81 percent owned subsidiary of Novogen
Limited.
For more information, visit www.glycotexinc.com
About Novogen Limited:
Novogen Limited (NASDAQ: NVGN) (ASX: NRT) is an Australian
biotechnology company that has patented isoflavones and glucan
technologies for the treatment and prevention of degenerative
diseases and disorders. Novogen is involved in drug discovery and
product development for disorders that are commonly associated with
aging and coordinates an international clinical research and
development program with external collaborators, hospitals and
universities. For more information, visit 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.
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Contacts: David Sheon 202 518-6321 Email Contact
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