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

peline candidate," said Travis E. Baugh, President and Chief Operating Officer of Healthpoint Biotherapeutics. "We look forward to the results of the pivotal registration studies for HP802-247 and, ultimately, to bringing a significant advance in the treatment of venous leg ulcers to the millions of patients suffering from this debilitating condition."

For more information about the HP802-247 North American clinical trial, go to www.LegSoreStudy.com, or call 866-910-2020 to speak with a clinical trial recruitment specialist.

About HP802-247

HP802-247 is an investigational allogeneic living human cell bioformulation that consists of two components that are sprayed sequentially on the wound bed at the time of treatment: a fibrinogen solution and a cell preparation containing a mixture of growth arrested, living, allogeneic epidermal keratinocytes and dermal fibroblasts.

Based on in vitro studies, HP802-247 is believed to release various growth factors and cytokines into the micro-environment of the wound. These living cells are anticipated to interact with the patient's own cells to stimulate wound healing.  HP802-247 has been designed to deliver a defined cell ratio (keratinocyte:fibroblasts) to support optimal tissue regeneration.

Positive results for a Phase IIb clinical trial investigating the efficacy of HP802-247 in venous leg ulcers were recently published in The Lancet. The study was a randomized, double blind, dose-finding study involving 228 subjects enrolled across 35 investigational centers in the United States and Canada. 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
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SOURCE Healthpoint Biotherapeutics
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