RegeneRx Biopharmaceuticals, Inc. announced that a major pharmaceutical firm confirmed that thymosin beta 4 (TB4) significantly improved cardiac function when administered to laboratory animals immediately following induced myocardial infarction (heart attack). This data confirmed the 2004 publication in Nature that indicated statistically significant improvement in cardiac function in animals receiving TB4 after a heart attack compared to those receiving only a placebo.
Additionally, the researchers found significant cardiac hemodynamic improvements (blood flow, cardiac pressures and contractility), reduced cardiac hypertrophy (enlargement of the heart), and reduction in pulmonary edema (accumulation of fluid in the lungs) in the animals receiving TB4 compared to placebo. These are important cardiovascular and cardiopulmonary functional parameters related to specific types of heart failure and further extend our knowledge regarding the potential effects of TB4 for the treatment of acute heart attack, as well as congestive heart failure. Due to confidentiality obligations neither the pharmaceutical company nor specific data can be identified at this time.
"These results are very important for several reasons. First, the collaborative research confirms the data published in Nature that is the foundation of our developmental efforts for TB4 in the cardiovascular field. Secondly, the new cardiovascular and pulmonary data are consistent with and extend the published cardio-protective findings. And, finally, that a major pharmaceutical company is interested in and able to reproduce the data in their labs gives us additional confidence that we are pursuing not only a novel drug candidate, but also a viable one," commented Dr. Allan L. Goldstein, RegeneRx's chief scientific advisor and Chairman of Biochemistry and Molecular Biology at The George Washington University School of Medicine and Health Sciences in Washington, D.C.
"This new information will support the filing of our cardiovascular IND with the FDA, which is expected later this year," commented J.J. Finkelstein, RegeneRx's president and chief executive officer. "While we will continue to evaluate partnership opportunities in the cardiovascular field, we believe that independently developing TB4 through Phase II clinical trials is the best strategy to maximize shareholder value and remains consistent with our stated long-term objectives. We expect to see patient data from our cardiovascular clinical trial in 2007, which will be a key clinical milestone and will influence all future partnership decisions," Finkelstein concluded.
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. One of TB4's key mechanisms of action is its ability to regulate the cell-building protein, actin, a vital component of cell structure and movement. Additionally, TB4 directly influences the production of laminin-5, a protein responsible for proper adhesion and migration of certain types of mammalian cells and often deficient in patients with EB. It has also recently been reported that TB4 can inhibit or prevent apoptosis (programmed cell death) in ocular tissue and cardiac tissue. Researchers at the National Institutes of Health, and at other academic institutions throughout the US, have published numerous scientific articles indicating that TB4 is effective in accelerating dermal and corneal wound healing in several animal models, under a variety of conditions. In an article published in the scientific journal, Nature, researchers found that TB4 protects heart tissue following a myocardial infarction (heart attack) in laboratory animals.