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Healthpoint Biotherapeutics Initiates Phase III Study of Unique Investigational Cell-Based Therapy for Venous Leg Ulcers
Date:9/11/2012

FORT WORTH, Texas, Sept. 11, 2012 /PRNewswire/ -- Healthpoint Biotherapeutics today announced the initiation of a Phase III clinical trial investigating the efficacy of HP802-247 for the treatment of venous leg ulcers. HP802-247 is an investigational allogeneic living cell bioformulation containing keratinocytes and fibroblasts. The study is designed to evaluate complete wound closure in subjects receiving HP802-247 plus compression therapy compared to those receiving vehicle control plus compression therapy over the 12-week treatment period.

Venous leg ulcers affect approximately 2.5 million Americans and are associated with impaired circulation most commonly resulting from damaged veins and/or valves. They typically appear as an open lesion, or ulcer, on the lower extremities, are very slow to heal and often reoccur due to the chronic nature of the underlying disease process.

"Following the favorable results achieved in our Phase IIb trial, we are very pleased to be initiating the Phase III study for this first-in-class cell-based therapy," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint Biotherapeutics. "In addition to this multicenter North American study, our development strategy includes a second multicenter trial, which we plan to initiate next year at centers across Europe."

The North American study is a randomized, double-blind study involving subjects 18 years of age and older with venous leg ulcers of at least 6 weeks but not more than 24 months duration. The ulcers must be between 2 cm2 and 12 cm2 in area at presentation. Approximately 440 subjects will be enrolled across 45 investigational centers in the United States and Canada.

"As is evidenced by our ongoing $60 million investment in a state-of-the-art cell sciences research and manufacturing facility at our headquarters in Fort Worth, Healthpoint Biotherapeutics is committed to advancing the development of our lead pi
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SOURCE Healthpoint Biotherapeutics
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