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Home » RegeneRx to Initiate Phase II Trial With TB4 for Epidermolysis Bullosa
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.
KEYWORDS Drug Pipeline Alert
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