Healthpoint initiates Phase II venous leg ulcers study

Healthpoint, an affiliate of DFB Pharmaceuticals, a specialty pharmaceutical company, 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.

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 six weeks, but not more than 24 months duration. The ulcers must be between 2cm2 and 12cm2 in area at presentation. Approximately 400 subjects will be recruited at 25 investigational centers in the US.

The study will assess both the time to complete wound closure and the proportion of complete wound closures in each cohort.

Bert Slade, chief medical officer of Healthpoint, said: Commencement of enrollment for this trial represents an important milestone in the development program for this novel biologic therapy. 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.