RegeneRx Biopharmaceuticals, Inc. /quotes/comstock/14*!rgn/quotes/nls/rgn (RGN 0.37, +0.03, +8.82%) announced today that in a preclinical research paper published in the May 2010 issue of the Journal of Neurosurgery, (online ahead of publication), scientists found that the systemic administration of thymosin beta 4, or TB4, significantly reduced brain tissue damage and improved brain function in rats with traumatic brain injury, or TBI. In the study, 10 rats were injected with TB4 one day following the inducement of TBI and four times thereafter over a 12-day period, while 9 rats were injected with a placebo or saline solution. In the group of rats treated with TB4, researchers observed reduced cell loss in the hippocampus, a part of the brain that plays an important role in long-term memory, as compared to the placebo group. The rats treated with TB4 also experienced growth of new blood vessels and neurons in the injured cerebral cortex, growth of brain cells known as oligodendrocytes in the CA3 field of the hippocampus, and recovery of sensory and motor functions as well as spatial learning. The researchers noted that the data for the first time demonstrate that delayed administration of TB4 significantly improves histological and functional outcomes in rats with TBI, indicating that TB4 has considerable therapeutic potential for patients with TBI.
"We believe these results are very encouraging. The fact that TB4 was administered beginning one day following injury and was still able to improve outcomes is significant," added Dr. Allan L. Goldstein, professor of biochemistry and molecular biology at the George Washington University Medical School, and chairman of the board of directors and chief scientific advisor for RegeneRx. "We have now seen compelling data using TB4 in three different animal models -- an EAE mouse model for multiple sclerosis, a rat model for embolic stroke, and this new study in traumatic brain injury -- that have each demonstrated TB4's ability to promote angiogenesis, regenerate neuronal tissue, and improve functional outcome. These data are also consistent with previously published studies showing regeneration of heart tissue after ischemic injuries to the myocardium."
About RegeneRx Biopharmaceuticals, Inc.
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 formulated three product candidates in clinical development: RGN-352, an injectable formulation for systemic delivery to treat cardiovascular diseases, central nervous system diseases, and other medical indications that require administration by injection, that has completed a Phase 1 clinical trial; RGN-259, a sterile, preservative-free topical eye drop for ophthalmic indications that is currently being supported in compassionate use studies; and RGN-137, a topically applied gel for chronic dermal wounds and reduction of scar tissue that is currently in a Phase 2 clinical trial for the treatment of epidermolysis bullosa. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack, although recent animal research suggests that this formulation may also benefit patients with multiple sclerosis and stroke. RegeneRx has a fourth product candidate, RGN-457, which is an inhaled formulation targeting cystic fibrosis and other pulmonary diseases, in pre-clinical development. These product candidates are based on TB4, a synthetic copy of a 43-amino acid, naturally-occurring peptide that is the subject of an exclusive worldwide license from the National Institutes of Health. In addition to the four pharmaceutical product candidates described above, RegeneRx is pursuing the commercial development of peptide fragments of TB4 for potential cosmeceutical use. RegeneRx holds over 60 worldwide patents and patent applications related to its product candidates.
Forward-Looking Statements
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