Glycotex has obtained an active investigational new drug application from the FDA for the start of a randomized, double-blind, placebo-controlled Phase IIa clinical trial of its lead topical product candidate GLYC-101, for the treatment of burn wounds.
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The Phase IIa human clinical trial to be conducted in the US is 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 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.
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