Regenerx Biopharmaceuticals, Inc. announced that an independent international team of medical researchers have presented new data showing that administration of thymosin beta 4 (TB4) significantly decreased heart damage after cardiac ischemia and reperfusion in pigs at the American Heart Association meeting.
In this study, the animals underwent LAD occlusion (blockage of coronary artery) for 60 minutes to simulate a heart attack and were then reperfused (opening of coronary artery) to simulate the standard of care for heart attack patients. TB4 or placebo was then infused directly into the damaged area. TB4 significantly decreased cardiac tissue damage, enhanced function of the damaged heart tissue, and reduced MPO levels (an enzyme associated with inflammation and adverse outcomes in patients with acute coronary syndrome) when compared to placebo. According to the researchers, "Consistently, TB4 protein suffices to provide significant cardioprotection after ischemia and reperfusion.
"We believe this study is notable for several important reasons: (1) this is the first time the cardioprotective effects of TB4 have been shown in a porcine (pig) model, the closest model to human cardiovascular structure and behaviour; (2) this is the first study to show TB4's cardioprotective effects in an ischemia-reperfusion model, i.e., a coronary artery is blocked to simulate an acute heart attack and then reopened to establish blood flow, which is the standard of care used in human patients whenever possible; and (3) this study confirms and elaborates the results seen in the original work published in Nature by Dr. Deepak Srivastava and his colleagues in 2004, as well as unpublished data using TB4 in permanently ligated, small animal models.
"A number of clinical trials are currently underway to test the ability of blood-derived stem cells to protect and repair the heart after a heart attack. TB4 is one of the most abundantly secreted proteins from such cells and this study suggests that TB4 may also be the key component common to these cells. If this is the case in humans, it may be possible to simply use TB4 rather than complicated stem cell therapies for the treatment of acute myocardial infarction and other similar medical indications," stated Dr. Deepak Srivastava, Director of the Gladstone Institute of Cardiovascular Disease and Distinguished Professor in Paediatric Developmental Cardiology at the University of California, San Francisco.
"We have been following closely the evolving story of TB4 for cardiovascular protection and repair since the 2004 Nature paper. This latest data showing TB4's positive effects on the pig heart after ischemia and reperfusion are very compelling as this is the best possible model in which to show efficacy other than in human clinical trials. It appears TB4's translation into a human therapeutic compound has considerable potential for success," stated Dr. Alan Wasserman, Eugene Meyer Professor of Medicine and Chairman, Department of Medicine, The George Washington University Medical Center, Washington, D.C.
The research team consisted of 11 researchers from Klinikum GroBhadern, University of Munich, Munich, Germany; Vanderbilt University, Nashville, Tennessee; and the University of Texas South-western Medical Centre, Dallas, Texas.
RegeneRx is focused on the discovery and development of novel 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. Preliminary research suggests that TB4 may prove efficacious for multiple indications; therefore, RegeneRx is developing TB4 as the cornerstone of its therapeutic platform. The technology platform has many potential applications in both the pharmaceutical and consumer products sectors.
RegeneRx holds over 60 world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, cardiac and neurological protection and injuries, septic shock and several consumer product areas.