TB4 Provides Both Neuroprotection and Neurorestoration When Administered Shortly after Traumatic Brain Injury in Rat …

ROCKVILLE, Md.--(BUSINESS WIRE)--

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (the Company or RegeneRx) reported that data showing that Thymosin beta 4 (T4) provides both neuroprotection and neurorestoration after traumatic brain injury (TBI), was published in the current (May 2012) edition of the Journal of Neurosurgery, 116:10811092.

As reported in the epub edition of the journal, the aims of the study were to test if T4 treatment initiated 6 hours after traumatic brain injury in rats reduces brain damage and improves functional recovery. According to the research team, Compared with saline administration, T4 treatment initiated 6 hours postinjury significantly improved sensorimotor functional recovery and spatial learning, reduced cortical lesion volume and hippocampal cell loss, and enhanced cell proliferation and neurogenesis in the injured hippocampus. Thymosin 4 treatment initiated 6 hours postinjury provides both neuroprotection and neurorestoration after TBI, indicating that T4 has promising therapeutic potential in patients with TBI.

These results are extremely encouraging and are consistent with results of T4 administration in other Central nervous system injuries, as well as in cardiovascular injury models. Moreover, the reduction of brain damage, improved motor function, and regeneration of injured brain tissue, when T4 is administered 6 hours after TBI, suggest that it could potentially be useful for the treatment of brain traumas seen in the military, the workplace and in contact sports, stated Dr. Allan Goldstein, Professor and Chairman Emeritus, Department of Biochemistry and Molecular Biology, The George Washington University School of Medicine, Washington, D.C. Dr. Goldstein is also chairman of and chief scientific advisor to RegeneRx.

The research was conducted by Xiong Y, Zhang Y, Mahmood A, Meng Y, Zhang ZG, Morris DC, and Chopp MJ in the Departments of Neurosurgery, Neurology, and Emergency Medicine at the Henry Ford Hospital System (HFHS), in Detroit, Michigan and Department of Physics, Oakland University, in Rochester, Michigan pursuant to a material transfer agreement between the hospital and RegeneRx Biopharmaceuticals, Inc.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or T4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development and has an extensive worldwide patent portfolio covering its products.

RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on a recently completed Phase 2 clinical trial in patients with dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. We believe the positive results of this Phase 2 exploratory trial reflect RGN-259s reported mechanisms of action and provide RegeneRx with FDA-approvable endpoints to be targeted in future clinical trials.

RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack. Recent pre-clinical efficacy data suggests that RGN-352 may also benefit patients with multiple sclerosis, stroke and traumatic brain injury. RegeneRx has successfully completed a Phase 1 clinical trial with RGN-352 in which the drug candidate was found to be safe and well-tolerated. In 2010, RegeneRx received a $3 million, three-year development grant from the NIH to support the company's acute myocardial infarction program.

RGN-137, a topical gel formulation, is currently being evaluated by RegeneRx in a Phase 2 clinical trial for the treatment of the orphan skin disease epidermolysis bullosa. Other potential uses for RGN-137 include the treatment of chronic dermal wounds and reduction of scar tissue. RegeneRx previously received $675,000 in grants from the U.S. FDA to support this clinical trial.

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TB4 Provides Both Neuroprotection and Neurorestoration When Administered Shortly after Traumatic Brain Injury in Rat ...