Glycotex, Inc. announced
enrollment of the first patient in a Phase IIb study evaluating the effect
of GLYC-101 on wound closure and cosmetic outcomes in cosmetic surgery
patients undergoing carbon dioxide laser skin resurfacing on the lower
eyelid area.
A previous Phase II Pilot Study, investigating clinical outcomes and
safety parameters of GLYC-101 at two doses compared to placebo was
completed in April 2008.
The current randomized, double-blind, placebo-controlled clinical study
will enroll approximately 48 patients at one clinical trial site in Beverly
Hills, California. Patients will be randomized to receive either GLYC-101
0.1% or GLYC-101 1.0% gel on one lower eyelid, and placebo on the other
lower eyelid applied topically to the laser-ablated area immediately
following the laser procedure and for four consecutive days thereafter. The
primary efficacy endpoint of the study is time to wound healing, and the
secondary efficacy point is cosmetic outcomes, including scarring. The
study will observe the effects of the topical agent over the course of one
month following the initial treatment with the investigational compound and
placebo.
About GLYC-101
GLYC-101 is intended 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
glycotexinc.
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Glycotex, Inc.
glycotexinc