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Results For Phase 2b Trial Of Unique Investigational Cell-Based Therapy In Venous Leg Ulcers Published In The Lancet
Date:8/2/2012

FORT WORTH, Texas, Aug. 2, 2012 /PRNewswire/ -- Healthpoint Biotherapeutics today announced that the results for its Phase 2b clinical trial investigating the efficacy of HP802-247 in venous leg ulcers is published on The Lancet, beginning August 3, 2012, with Online First access to the article, followed by print publication in the next issue. HP802-247 is an investigational allogeneic living cell bioformulation containing keratinocytes and fibroblasts currently under development for the treatment of venous leg ulcers.

"We are very pleased that the trial results are appearing in such a prestigious general medical journal, thus recognizing the impact chronic wounds have across multiple medical specialties," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint Biotherapeutics.

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.

The Phase 2b trial was designed to determine the potential effectiveness of two cell concentrations and two dosing frequencies of HP802-247, when combined with standard care, compared to control plus standard care, in healing venous leg ulcers over a 12-week treatment period. The study was a randomized, double blind, dose-finding study involving 228 subjects enrolled across 35 investigational centers in the United States. Overall, HP802-247 achieved statistical significance, as compared with control plus standard care, in both the primary and secondary endpoints. HP802-247 was generally well tolerated in the study with the most frequently reported adverse events being skin ulcers, cellulitis, wound infection, and skin irritation.  The safety profile of the active groups was similar to the vehicle
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SOURCE Healthpoint Biotherapeutics
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