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'Spray-On Skin' for Leg Ulcers Flops in Clinical Trial

Living-cell bioformulation fails to provide significant improvement

Disappointing results have been announced from a phase III study of HP802-247 (Smith & Nephew), a living-cell spray-on therapy designed to work with the body’s own cells to stimulate healing of venous leg ulcers (VLUs).

HP802-247 did not meet the study’s primary endpoint — a statistically significant improvement in healing — compared with placebo in the randomized, double-blind, vehicle-controlled study, conducted in North America.

A full analysis of the efficacy data and study methods is underway and will be completed in the coming months. A second phase III study in the European Union, which is expected to report in 2016, will continue while the program analysis is completed. HP802-247 is an allogenic living-cell bio-formulation of irradiated keratinocytes and fibroblasts in a human fibrin suspension.

In June 2011, a phase IIb clinical trial demonstrated that HP802-247 met both its primary and secondary endpoints in the treatment of VLUs. The compound entered phase III trials for this indication in North America in September 2012.

The new study measured complete wound closure over a 12-week period in patients treated with HP802-247 plus standard-of-care compression compared with treatment with placebo plus compression. The study involved subjects 18 years of age and older with VLUs of at least 6 weeks’ duration but not more than 24 months’ duration.

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