RegeneRx Completes Patient Enrollment of First Phase II Clinical Trial of Topical Drug Candidate RGN-137
RegeneRx Biopharmaceuticals, Inc. announced that it completed enrollment of its first of four ongoing Phase II clinical trials. The trial is a double-blind, placebo-controlled, dose-escalating clinical trial evaluating the safety and efficacy of the Company’s topical drug candidate, RGN-137, in seventy-two 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. Twenty-two wound care centers and hospitals in the United States have participated in the study. The Company expects to report results in the fourth quarter of 2008.
“Clearly, we are excited about reaching this important milestone. While each of our Phase II trials will stand on its own and give us valuable information in separate medical indications, this trial will give us the first information on RGN-137’s safety and efficacy in dermal wound healing. 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,” stated David Crockford, RegeneRx’s vice president for clinical and regulatory affairs.
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