RegeneRx to Initiate Phase II Trial With TB4 for Epidermolysis Bullosa

RegeneRx Biopharmaceuticals is clear to begin its third Phase II clinical trial to test its drug, Thymosin beta 4 (TB4), for the treatment of patients with epidermolysis bullosa (EB), the company said.

The Phase II trial is a randomized, double-blind, placebo-controlled trial designed to test several dosages of TB4 in a limited number of patients with dystrophic and junctional EB at a number of medical centers in the U.S. The drug will be topically administered to each patient every day over a period of several weeks.

Under the Orphan Drug Act, grants to fund Phase II and Phase III clinical trials for orphan-designated products may be available from the FDA. RegeneRx has previously applied for such a grant and will await word from the agency before formally initiating the study.