The trial is a double-blind, placebo-controlled, dose-escalating clinical study evaluating the safety and efficacy of the company’s topical drug candidate, RGN-137, in 72 patients with pressure ulcers who are being treated for up to 84 days or less if fully healed.
RGN-137 is a formulation of thymosin beta 4 specifically for topical delivery to dermal wounds. Approximately 22 wound care centers and hospitals in the US have participated in the study. The company expects to report results in the fourth quarter of 2008.
David Crockford, vice president of clinical and regulatory affairs at RegeneRx, said: “Currently there are no pharmacological agents approved for improving the healing of pressure ulcers and we look forward to reporting the results once they are available.”