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www.fdanews.com/articles/67670-regenerx-s-tb4-subject-of-phase-ii-clinical-trial-in-europe-for-venous-stasis-ulcers

REGENERX'S TB4 SUBJECT OF PHASE II CLINICAL TRIAL IN EUROPE FOR VENOUS STASIS ULCERS

January 18, 2005

RegeneRx Biopharmaceuticals has announced a second Phase II clinical trial to test its drug, Thymosin beta 4 (TB4), for the treatment of venous stasis ulcers.

The Phase II trial will be a randomized, double-blind, placebo-controlled trial designed to test several dosages of TB4 in patients with venous stasis ulcers in Italy and at least one other European country. The drug will be topically administered to each patient over a period of several weeks.

The study is scheduled for the second quarter of 2005 and should be completed and analyzed within approximately one year from enrollment of the first patient. This trial is the second in a portfolio of complementary clinical trials planned by RegeneRx, designed to evaluate TB4's effect on wound healing for specific types of dermal and ocular wounds.