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Glycotex, Inc. Expands Patent Portfolio in Advanced Wound Healing Indications
Thursday, February 11, 2010
Rockville, MD -- Glycotex, Inc. today announced the expansion of its patent portfolio in Advanced Wound Healing for its product candidate GLYC-101 currently in clinical phase 2 in the United States.
On January 19, 2010 US Patent No. 7,648,968 issued with claims directed to the use of microparticulate glucan including GLYC-101 for the treatment of dermal ulcers. The grant of this US patent represents a significant development in Glycotex's US patent portfolio as it provides protection for the therapeutic application of GLYC-101 independent of the method of production of the glucan.
Over the last twelve months, Glycotex has continued to strengthen its patent position around the world in relation to its microparticulate glucan technology. US Patent No. 7,622,575 issued on November 24, 2009 with claims directed to the treatment of tendon and ligament injuries using microparticulate glucan including GLYC-101.
Also, Canadian and Japanese patents were granted in the second half of 2008 adding to the portfolio of US, European, UK and Australian patents. The Canadian patent protects the production of microparticulate glucan and uses of the glucan for the treatment of a variety of conditions and disorders including skin ulceration, dermal ulcers associated with dysfunctional healing, UV light induced skin damage, bone fractures and the enhancement of fixation of orthopaedic devices. The Japanese patent protects the production of microparticulate glucan. Treatment uses of the glucan are being pursued in Japan in a pending application.
Glycotex is committed to further developing and strengthening its IP position and has filed five new international patent applications over the last 12 months.
GLYC-101 is being developed to stimulate and modulate the natural cascade of wound healing activities of several cell populations. The product candidate is a topical gel to be applied directly on the wound surface. In May 2006, Glycotex completed a Phase II clinical trial of GLYC-101 in Australia, in which GLYC-101 produced a statistically significant rate of wound area reduction versus combined placebo and standard care in patients with chronic venous ulcers. The results provided proof-of concept and dose-ranging information for GLYC-101.
In 2009 results from a scheduled interim analysis from a phase 2 clinical study, conducted in the U.S. under an IND, were announced. In this study, the effects of investigational GLYC-101 gel on complete wound closure and cosmetic outcomes were evaluated in cosmetic surgery patients undergoing carbon dioxide laser skin resurfacing on the lower eyelid area. These interim results suggested that the time to wound closure will be shorter for eyelids treated on the active arms when compared to placebo in the final analysis.
The strategic priorities for GLYC-101 include wound healing following laser ablation, burn wounds, surgical wounds, venous ulcers, and diabetic ulcers.
About Glycotex, Inc.
Glycotex, Inc. is a U.S. 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 Limited certain patent rights and know-how 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.
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 of our products to obtain such approval; uncertainties or differences in interpretation of 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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