FORT WORTH, Texas, July 25, 2012 /PRNewswire/ -- Healthpoint Biotherapeutics today announced that the results of a 24-week open-label follow-up to the HP802-247 Phase 2b trial will be presented by Robert Kirsner, MD, PhD, on Friday, July 27, 2012, from 3:55-4:15 pm, during the American College of Wound Healing and Tissue Repair held at the Swissotel in Chicago. HP802-247 is an allogeneic living cell bioformulation containing keratinocytes and fibroblasts currently being investigated for the treatment of venous leg ulcers.
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 control.
The 24-week open-label extension of this Phase 2b trial was designed to evaluate the status of the target wound (e.g., open, re-opened or healed), as well as the status of the periwound area following the 12-week treatment period. HP802-247 was not administered to patients durin
|SOURCE Healthpoint Biotherapeutics|
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