Tβ4 is a multi-faceted molecule. It influences numerous biological activities related to wound, tissue and organ repair. |
Technology INTRODUCTION TO Tβ4Originally isolated from the thymus gland, Thymosin Beta 4 (Tß4) is now produced synthetically. It consists of 43-amino acid residues and is found in high concentration in blood platelets, wound fluid, white blood cells, and in most other tissues of the body. Tß4 is neither a growth factor nor a cytokine. Rather, Tß4 is the major actin-regulating molecule in most mammalian cells and plays an important role in the regeneration, remodeling, and healing of injured or damaged tissues. In peer-reviewed scientific publications, independent researchers have shown that Tß4 is multi-faceted and involved in a wide variety of biological activities including: regulation of actin, epithelialization, angiogenesis, apoptosis, and anti-inflammation. In combination, these properties distinguish it from other drugs on the market or under development in the wound healing field. The fact that Tß4 influences so many important biological processes may be one reason why the molecule is so highly conserved and remains essentially unchanged throughout evolution. RegeneRx began preparing for its clinical program several years ago, conducting over fifteen pre-clinical animal studies looking at toxicity, pharmacokinetics and other parameters necessary to conform to U.S. FDA regulations. Tß4 has been administered both topically and systemically in rodents and non-human mammals and the company has looked at its effect when topically applied to intact skin in humans in a Phase I clinical trial. To date, Tß4 has been well tolerated and exhibited no toxicity. Subsequently, the Company initiated three Phase II dermal wound healing clinical trials that are currently in progress, and has been cleared by the FDA to initiate a Phase II ophthalmic wound healing trial and a Phase I study to support an acute myocardial infarction clinical trial. Tß4’S BIOLOGICAL PROPERTIES & MECHANISMS OF ACTION:
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