ROCKVILLE, Md., April 7 /PRNewswire/ -- Glycotex, Inc. today announced the completion of a scheduled interim analysis in a Phase II study evaluating the effect of investigational GLYC-101 gel on complete wound closure and cosmetic outcomes in cosmetic surgery patients undergoing carbon dioxide laser skin resurfacing on the lower eyelid area.
The interim analysis was conducted after 26 subjects completed the study. The comparison of each active arm to placebo with respect to the primary endpoint (time to complete wound closure) shows positive results when considering the full dataset of patient data from all treatment combinations.
Specifically, the efficacy outcomes were statistically significantly different when comparing GLYC-101 0.1% and GLYC-101 1.0% groups to placebo (p values are 0.0062 and 0.0331, respectively). These interim results suggest that the time to wound closure will be shorter for eyelids treated on the active arms when compared to placebo in the final analysis. Assessment of safety data is ongoing.
This ongoing Phase II randomized, double-blind, placebo-controlled clinical study will continue enrolment to approximately 48 patients at one clinical trial site in Beverly Hills, California. Patients are randomized to receive either GLYC-101 0.1%, GLYC-101 1.0%, or placebo gel on one lower eyelid, and a different test article on the other lower eyelid applied topically to the laser-ablated area immediately following the laser procedure and for four consecutive days thereafter for a total of five applications. The primary efficacy endpoint of the study is time to complete wound healing, and the secondary efficacy point is cosmetic outcomes, including scarring. The study is observing the effects of the topical agent over the course of one month following the initial treatment with the investigational compound (GLYC-101 gel) or placebo.
A previous Phase II Pilot Study, investigating clinical outcomes and safety parameters of GLYC-101 gel at two doses compared to placebo, was completed in April 2008.
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.
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.
|SOURCE Glycotex, Inc.|
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