RegeneRx Biopharmaceuticals, Inc. announced that a research team from the Molecular Medicine Unit at UCL-Institute of Child Health in London reported preclinical findings that Thymosin beta 4 (TB4), is essential to healthy heart development and embryonic survival.

The research was conducted by Drs Nicola Smart, Karina Dubé and Paul Riley, and was published online in Nature Communications; 2010 July 27; DIO 10.1038/ncomms1041. The research was performed under a Material Transfer Agreement between RegeneRx Biopharmaceuticals, Inc. and the UCL-Institute.

In the study, mice embryos were genetically modified not to produce Hand1, a key transcription factor that plays a fundamental role in the normal development of the heart and in congenital heart disease. Without Hand1, TB4 is down-regulated, hearts are malformed and the embryos do not survive. In this study, injection of synthetic TB4 into pregnant female mice lacking Hand1 resulted in normal development and in the survival of the early embryos. This paper provides the first direct evidence that TB4 plays a critical role in early embryonic vessel development and identifies a novel Hand-1-TB4 pathway.

"These findings are important in that they establish the molecular mechanism by which TB4 stimulates vascular growth of the embryo and opens up the possibility of utilizing TB4 to potentially correct serious heart defects in utero," stated Allan Goldstein, Ph.D., Professor of Biochemistry and Molecular Biology at The George Washington University School of Medicine and Founder and Chief Scientific Advisor of RegeneRx.

"We believe this research further supports development of RGN-352, an injectable formulation of TB4, in acute myocardial infarction," said J.J. Finkelstein, chief executive officer of RegeneRx. "We plan to begin a Phase 2 study in AMI later this year."

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 has identified several molecular variations of TB4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health and various academic researchers throughout the world have published numerous scientific articles in high impact journals indicating TB4's in vitro and invivo efficacy in accelerating wound healing and tissue protection and regeneration under a variety of conditions. Abstracts of scientific papers related to TB4's mechanisms of action can be viewed at www.regenerx.com.

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or TB4, for tissue and organ protection, repair and regeneration. Currently RegeneRx has three products in clinical development. RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications.