RegeneRx Biopharmaceuticals, Inc. has announced that researchers have found that Thymosin Beta 4 (TB4), in a dose dependent manner, stimulates oligodendrogenesis, the process by which Central Nervous System (CNS) progenitor cells (immature specialized brain cells) become oligodendrocytes that secrete myelin, the covering of nerve fibres. This process is important for the repair, regeneration and function of CNS tissue damaged by disease or trauma.

The research team was led by Dr Dan Morris, of the Henry Ford Hospital System in Detroit, Michigan. Dr Morris is presenting his findings at the Society of Academic Emergency Medicine meeting on June 1st.

Dr Morris has previously shown that TB4 significantly improves neurological functional outcome in a CNS rat model after embolic stroke. His work in the field brings us closer to understanding the mechanisms underlying the differentiation of immature oligodendrocytes into mature oligodendrocytes in patients suffering stroke, multiple sclerosis and traumatic brain injury.

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or TB4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development and has an extensive worldwide patent portfolio covering its product candidates.

RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on recent human clinical data, RegeneRx is currently supporting a physician-sponsored phase II dry eye study with RGN-259 and has completed to animal studies showing RGN-259's positive effects on dry eye symptoms. Previously, seven patients with non-healing corneal ulcers were treated with RGN-259 under compassionate use INDs. Five had complete healing and two had substantial healing of their wounds. Three additional patients with corneal defects, called punctate keratitis, had no evidence of healing although they did report reduction in eye inflammation and increased comfort.

RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. RegeneRx has successfully completed a phase I clinical trial with RGN-352 in which the drug candidate was found to be safe and well-tolerated. The company has initiated a phase II clinical trial at approximately 20 clinical sites in the US, Israel, and Russia, although this trial is currently on an FDA-imposed clinical hold. RegeneRx recently received a $3 million, three-year development grant from the NIH to support the company's acute myocardial infarction program.

RGN-137, a topical gel formulation, is currently being evaluated by RegeneRx in a phase II clinical trial for the treatment of the orphan skin disease epidermolysis bullosa. Other potential uses for RGN-137 include the treatment of chronic dermal wounds and reduction of scar tissue.