Researchers Show TB4 Provides Both Neuroprotection and Neurorestoration after Traumatic Brain Injury

ROCKVILLE, Md.--(BUSINESS WIRE)--RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today announced that researchers have shown that Thymosin beta 4 (Tβ4) “provides both neuroprotection and neurorestoration after traumatic brain injury (TBI), indicating that Tβ4 has promising therapeutic potential in patients with TBI.”

“provides both neuroprotection and neurorestoration after traumatic brain injury (TBI), indicating that Tβ4 has promising therapeutic potential in patients with TBI.”

The aims of the study were to test if Tβ4 treatment initiated 6 hours after traumatic brain injury in rats reduces brain damage and improves functional recovery. The rats were divided into two treatment groups and one placebo group. Tβ4 or placebo was systemically administered 6, 24, and 48 hours after injury. Compared with the placebo group, Tβ4 treatment initiated 6 hours post-injury statistically significant improvement of sensorimotor functional recovery and spatial learning, reduced cortical lesion volume and hippocampal cell loss, and enhanced cell proliferation and neurogenesis in the injured brain tissue. The high dose of Tβ4 showed better beneficial effects compared with the low dose treatment.

The research was conducted by Xiong Y, Zhang Y, Mahmood A, Meng Y, Zhang ZG, Morris DC, Chopp MJ in the Department of Neurosurgery at the Henry Ford Hospital System (HFHS) in Detroit, Michigan pursuant to a material transfer agreement between the hospital and RegeneRx Biopharmaceuticals, Inc. and published in Neurosurg., 2012 Feb 10. [Epub ahead of print].

"This preclinical study on the use of Thymosin beta 4 for the treatment of traumatic brain injury adds to the growing body of literature demonstrating the use of Tβ4 in neurological injury. The collective evidence of the neurorestorative properties of Tβ4 in animal models of multiple sclerosis, stroke and traumatic brain injury are compelling and we look forward to evaluating this drug in clinical trials," stated Dr. Dan Morris, Senior Staff Physician, Department of Emergency Medicine at HFHS and one of the investigators in study.

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

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tβ4, 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-259’s 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. Forward-Looking Statements

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