Contact Information: Contacts: David Sheon 202 518-6321
Glycotex, Inc. Obtains Active IND From US Food and Drug Administration for GLYC-101 Wound Healing Compound
| Quelle: Glycotex, Inc., Novogen Limited
ROCKVILLE, MD--(Marketwire - January 7, 2008) - Glycotex, Inc. announced today that it had
obtained an active Investigational New Drug Application (IND) 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
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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
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from our dependence upon, collaboration or contractual arrangements
necessary for the development, manufacture, commercialization, marketing,
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to protect our patents or proprietary rights and obtain necessary rights to
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inability to operate our business without infringing the patents and
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of any revisions to these forward-looking statements.