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

Multi-Center, Randomized Trial to Test Unique Delivery System Using Living Cells to Enhance Wound Healing Marks Milestone for Fort Worth, Texas-based Specialty Biopharmaceutical Company

FORT WORTH, Texas, June 16 /PRNewswire/ -- HEALTHPOINT, Ltd. today announced that it has enrolled the first of a planned 235 subjects into a Phase II dose response study investigating an experimental, cell-based wound therapy ---HP802-247---intended for the treatment of venous leg ulcers. HP802-247 is a topical spray containing living keratinocytes and fibroblasts. The first patient was enrolled at The Center for Clinical Research near San Francisco, Calif., led by the site's principal investigator, Alexander Reyzelman, DPM. The study is being conducted by 28 investigators in 18 states.

"The start of enrollment into this multi-center, randomized trial is an important milestone for HEALTHPOINT," said Bert Slade, M.D., FAAAAI, Chief Medical Officer at HEALTHPOINT and co-author of the trial protocol. "This is the largest cell therapy dose ranging trial ever undertaken in the area of wound healing."

The trial is the second of two planned-dose response trials, extending the dose range being tested and exploring two plausible dose frequencies. Enrollment into the trial is preceded by screening and run-in phases and is expected to continue through the middle of 2010. The first trial showed promising results over a four-fold range of cell concentrations administered weekly.

This trial is evaluating the benefits and safety of enhancing wound healing by using metabolically active donor cells to support the patient's own skin cells' healing ability. HP802-247 utilizes allogeneic cells, which are living human cells derived from an individual donor that are subsequently grown in a tissue culture, and then applied to an unrelated patient. The HP802-247 product consists of both keratinocytes and fibrobl
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SOURCE HEALTHPOINT, Ltd.
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