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news.RegeneRx Biopharmaceuticals, which discovers and develops novel peptides to accelerate tissue repair and protection, has completed enrollment in the second of four ongoing Phase II clinical trials.
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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 patients with venous stasis ulcers.
There are 72 patients being treated for up to 84 days, or less if fully healed. RegeneRx’s first Phase II study, in patients with chronic pressure ulcers in the US, completed enrollment in August of 2008.
RGN-137 is a formulation of thymosin beta 4 specifically for topical delivery to dermal wounds. The clinical trial was conducted at 10 centers in Europe by Sigma-Tau Group, Rome, Italy, under RegeneRx’s investigational new drug. Sigma-Tau and RegeneRx expect to report results in the first quarter of 2009.
David Crockford, vice president for clinical and regulatory affairs at RegeneRx, said: “We are pleased that Sigma-Tau has completed enrollment of the second Phase II study with RGN-137. We look forward to reporting data from the study in the first quarter of 2009.”