Healthpoint intiates phase II clinical trial to evaluate effectiveness of HP802-247 in venous leg ulcers

Mar 16 2009

Healthpoint announced that it 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.

"Commencement of enrollment for this trial represents an important milestone in the development program for this novel biologic therapy," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint. "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."

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 6 week's, but not more than 24 months duration. The ulcers must be between 2 cm2 and 12 cm2 in area at presentation. Approximately 400 subjects will be recruited at 25 investigational centers in the United States. The study will assess both the time to complete wound closure and the proportion of complete wound closures in each cohort.

Venous leg ulcers are increasingly common and costly, and are often a cause of prolonged suffering for patients. These wounds can be characterized as difficult to heal and are typically caused by impaired microcirculation secondary to venous hypertension. Many venous ulcers fail to heal even after 3 months of standard treatment and develop into chronic, non-responsive wounds. Based on an estimated figure of 2.5 million venous leg ulcers in the United States alone and a study of actual direct treatment costs of $9,685 per person, the annual cost of treating these wounds is likely in the many billions of dollars. Accordingly, the availability of innovative and effective treatment strategies for such high-risk wounds could provide tremendous benefits to both patients and society.

"The novel format of this cell-based therapy shows great potential to deliver a compelling clinical and cost effectiveness profile," said Travis E. Baugh, President and Chief Operating Officer of Healthpoint. "The current study is an important part of our ongoing development strategy for advancing wound care therapies and our intended evidence-based dossier for regulatory filings in both the United States and Europe."

About HP802-247

HP802-247 consists of two components that are sprayed sequentially on the wound bed at the time of treatment: a fibrinogen solution and a cell preparation containing a mixture of growth arrested, living, allogeneic epidermal keratinocytes and dermal fibroblasts.

Based on in vitro studies, HP802-247 is expected to release various growth and angiogenic factors into the micro-environment of the wound through administration of these living, metabolically active, but non-proliferating cells that are trapped on the wound surface in a thin fibrin matrix. The secreted growth and angiogenic factors are anticipated to stimulate the patient's own cells to heal the wound.