FORT WORTH, Texas announced today that Healthpoint Biotherapeutics today announced that the results for its Phase 2b clinical trial investigating the efficacy of HP802-247 in venous leg ulcers is published on The Lancet, beginning August 3, 2012, with Online First access to the article, followed by print publication in the next issue. HP802-247 is an investigational allogeneic living cell bioformulation containing keratinocytes and fibroblasts currently under development for the treatment of venous leg ulcers.
"We are very pleased that the trial results are appearing in such a prestigious general medical journal, thus recognizing the impact chronic wounds have across multiple medical specialties," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint Biotherapeutics.
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 citation for the Phase 2b study manuscript is: Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. A Multicentre Randomized Dosing Trial of Spray-Applied Cell Therapy With Human Allogeneic Fibroblasts and Keratinocytes for the Treatment of Chronic Venous Leg Ulcers. Lancet 2012;pending.
The publication is accompanied by an expert Comment in which the authors note, "In a well-done clinical trial in The Lancet, Robert Kirsner and colleagues have clearly shown that a specific cell therapy for venous leg ulcers can lead to a significantly higher healing rate than for vehicle alone in hard-to-heal [venous] wounds for which compression treatment has been applied unsuccessfully."
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