REGENERX RECEIVES FDA GRANT TO DEVELOP TB4

RegeneRx Biopharmaceuticals has received a $545,000 grant from the FDA's Office of Orphan Products Development for the development of its drug candidate based on Thymosin beta 4 (TB4). The two-year grant will be used for a Phase II epidermolysis bullosa clinical trial, which is currently enrolling patients.

TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration and collagen deposition, and it down-regulates inflammation. One of TB4's key mechanisms of action is its ability to regulate the cell-building protein, actin, a vital component of cell structure and movement. Additionally, TB4 directly influences the production of laminin-5, a protein responsible for proper adhesion and migration of certain types of mammalian cells and often deficient in patients with epidermolysis bullosa, a genetic disease characterized by extremely fragile skin and recurring blisters.

The drug has also been found to inhibit or prevent apoptosis in ocular and cardiac tissue. Researchers at the National Institutes of Health have published findings that TB4 is effective in accelerating dermal and corneal wound healing in several animal models.