A Medical Device Daily

RegeneRx Biopharmaceuticals (Bethesda, Maryland) reported that it received its first patent related to the ability of its lead drug candidate, Thymosin beta 4 (Tb4), to prevent damage and promote healing associated with myocardial events, including heart attack, vessel occlusion and heart valve damage, among others.

The Australian patent includes Tb4, analogues, fragments and other derivatives, methods of use and delivery, either independently or in combination with other agents. Similar patent applications have been submitted throughout the world. On March 30, RegeneRx filed an investigational new drug application (IND) to initiate a Phase 1 trial in support of this indication.

"Tb4's cardio-protective and wound-healing effects on the myocardium have been among the most exciting developments in the recent history of our company. Two independent publications in Nature, plus additional confirmation by big pharma and other collaborators, have given us a certain degree of confidence that we are pursuing the right course, although we recognize that human clinical trials are the ultimate test," said J.J. Finkelstein, RegeneRx's president/CEO.

RegeneRx is focused on the discovery and development of molecules to accelerate tissue and organ repair. Currently, RegeneRx is developing Tb4, a 43 amino acid peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds nearly 60 world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, cardiac and neurological injuries, septic shock and several consumer product areas.

Tb4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation.