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Healthpoint Initiates Phase II, Dose-Finding Study to Evaluate Effectiveness of a Unique Cell Based Therapy in Venous Leg Ulcers
Date:3/16/2009

FORT WORTH, Texas, March 16 /PRNewswire/ -- Healthpoint today announced that it has initiated a Phase II clinical trial investigating the efficacy of HP802-247 in venous leg ulcers. HP802-247 is a topical spray containing living keratinocytes and fibroblasts. The study 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.

"Commencement of enrollment for this trial represents an important milestone in the development program for this novel biologic therapy," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint. "This second Phase II study will extend our understanding of this agent, which we believe will add to the promising results obtained in previous European clinical trials."

The study is a randomized, double blind, dose-finding study involving subjects 18 years of age and older with venous leg ulcers of at least 6 week's, but not more than 24 months duration. The ulcers must be between 2 cm2 and 12 cm2 in area at presentation. Approximately 400 subjects will be recruited at 25 investigational centers in the United States. The study will assess both the time to complete wound closure and the proportion of complete wound closures in each cohort.

Venous leg ulcers are increasingly common and costly, and are often a cause of prolonged suffering for patients. These wounds can be characterized as difficult to heal and are typically caused by impaired microcirculation secondary to venous hypertension. Many venous ulcers fail to heal even after 3 months of standard treatment and develop into chronic, non-responsive wounds. Based on an estimated figure of 2.5 million venous leg ulcers in the United States alone and a study of actual direct treatment costs of $9,685 per person, the annual cost of treating t
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SOURCE Healthpoint, Ltd.
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