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HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject for Second Phase II Study
Date:6/16/2009

apy shows great potential to deliver a compelling, cost-effective option."

The current trial is part of HEALTHPOINT's ongoing development strategy for advancing wound care therapies and further enhances HEALTHPOINT's evidence-based dossier for regulatory filings in both the United States and Europe, according to Mr. Baugh.

About the Study

The study is a randomized, double-blind, dose-finding study involving subjects 18 years of age and older who have had venous leg ulcers for a minimum of six weeks and a maximum of 24 months. The ulcers must be between 2 cm2 and 12 cm2 in area at presentation. The study will assess both the time to complete wound closure and the proportion of complete wound closures in each cohort. It is designed to determine the effectiveness of two cell concentrations and two dosing frequencies of HP802-247 when combined with standard care, compared to placebo plus standard care, in healing venous leg ulcers over a 12-week treatment period. All trial patients undergo compression bandaging with a four-layer system (Profore(R) System) in order to control leg swelling caused by the underlying vein dysfunction.

About HP802-247

HP802-247 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 expected to release various growth and angiogenic factors into the microenvironment of the wound through administration of these living, metabolically active, but nonproliferating cells that are trapped on the wound surface in a thin fibrin matrix. The secreted growth and angiogenic factors are anticipated to stimulate the patient's own cells to heal the wound.

About HEALTHPOINT, Ltd.

Since 1992, HEALTHPOINT has
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SOURCE HEALTHPOINT, Ltd.
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