SOURCE: Glycotex, Inc., Novogen Limited

January 07, 2008 18:58 ET

Glycotex, Inc. Obtains Active IND From US Food and Drug Administration for GLYC-101 Wound Healing Compound

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 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 Information