RegeneRx Biopharmaceuticals, Inc announced a research team from the Henry Ford Hospital in Detroit, MI, reported that Thymosin beta 4 (TB4), administered to rats after embolic stroke, improved neurological functional outcome compared to control animals.

The research was conducted by Dr Daniel Morris and his colleagues at the Department of Emergency Medicine, Henry Ford Health System, Detroit, MI, and published in Neuroscience, 2010 Aug 25 169(2) 674-682, http://www.ncbi.nlm.nih.gov/pubmed/20627173. The research was performed under a Material Transfer Agreement between RegeneRx Biopharmaceuticals, Inc and the Henry Ford Health System.

Improvement in neurological function was measured at various time intervals over a seven week period and was statistically significant. A statistically significant increase in remyelination of axons and vessel density in the ischemic boundary was also observed between rats receiving TB4 vs. controls, likely due to an increased mobilization of oligodendrocyte progenitor cells (brain stem cells that differentiate into cells that protect nerve fibers). mRNA levels for the epidermal growth factor receptor were determined in both normal and stroke rats treated with TB4 and were approximately 50% higher in the stroke-treated rats. This receptor has previously been shown to be a key regulator of progenitor cell expansion and tissue regeneration in response to brain injury and further confirms the role of TB4 in stem cell-mediated tissue repair.

"Some of these data were previously reported at an International Stroke Conference in March; however, the data published today include more specific information on functional remodeling and potential mechanisms of action related to recruitment and differentiation of oligodendrocyte progenitor cells. These data are compelling and elaborate previously reported data in EAE mice (experimental models for multiple sclerosis) and in traumatic brain injury in rats showing that TB4 can effect regeneration of neuronal cells after injury. In this experiment, after an ischemic stroke, neurological function in the rat models was significantly improved, apparently by remyelination of neurological axons (nerve fibers that conduct electrical signals) induced by TB4. The fact that TB4 helps repair and regenerate tissue after a brain injury strongly correlates with other published data showing TB4's ability to regenerate neuronal and cardiac tissue after ischemic events," stated Dr Hynda Kleinman, former head of cell biology at the National Institute of Dental and Craniofacial Research, NIH, and a consultant to RegeneRx.

TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-functional molecule that has been shown in pre-clinical studies to promote endothelial cell differentiation and migration in the heart and central nervous system, promote angiogenesis in dermal and cardiac tissues, increase keratinocyte migration and collagen deposition, and decrease inflammation by down-regulating inflammatory cytokines.

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or TB4, for tissue and organ protection, repair and regeneration.