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Glycotex, Inc. Releases Final Phase II Clinical Trials Results in the Clinicaltrials.gov Database and Announces the Results of the Mechanism of Action Study for its Product Candidate GLYC-101
Date:6/27/2011

tive days thereafter for a total of five applications.  The primary efficacy endpoint of the study was time to complete wound healing, and the secondary efficacy point was cosmetic outcomes, including scarring, observed over the course of one month following the initial application of GLYC-101 gel or placebo. In the overall analysis, time to complete wound closure was shorter for all GLYC-101 applications combined at each concentration compared to placebo (p values are 0.0062 and 0.0331 for GLYC-101, 0.1% and GLYC-101, 1.0%, respectively).  By Day 12, approximately 94% and 82% of subjects receiving GLYC-101, 0.1% and GLYC-101, 1.0 %, respectively, exhibited complete wound closure compared to approximately 64% of subjects receiving placebo. All subjects had complete wound closure by Day 35.  No serious adverse events considered to be related to GLYC-101 have been reported.

Preliminary clinical activity of GLYC-101 is consistent with the results of the mechanism of action studies. As described in a recent publication (S. Roy et al., Wound Repair Regen. 2011 May; 19(3):411-419), GLYC-101 was shown to regulate wound macrophage function by inducing production of tumor necrosis factor alpha (TNFa) in murine and human cells.   Activation of wound macrophages by GLYC-101 represents one of the potential mechanisms by which this beta-glucan may benefit chronic wounds where inefficient inflammatory response is one of the underlying causes of impaired healing.

About GLYC-101

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.

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
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SOURCE Glycotex, Inc.
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