Researchers Report that Long-Term Administration of Thymosin B4 in a Diabetic Animal Model Prevents Progression of Peripheral Neuropathy and Restores Sciatic Nerve Function

ROCKVILLE, Md., May 8, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that independent researchers have reported that diabetic mice treated long-term with Thymosin B4 (TB4) have significantly improved motor and sensory function in the sciatic nerve compared to the untreated animals and that TB4 protects the nerves and reverses neurological damage in diabetic neuropathy.

The improvement is closely associated with amelioration of sciatic nerve axonal and myelin damage and an increase of intraepidermal nerve fiber density.  In vitro, TB4-treated neurons derived from the diabetic mice had more extensive neurite outgrowth compared to the untreated neurons.  Furthermore, the researchers identified the protein that contributes to axonal remodeling. 

"These results demonstrate the positive effects that TB4 has on a well-accepted animal model of diabetic peripheral neuropathy and again confirms the ability of TB4 to repair damage and promote tissue regeneration in vivo.  The positive impact of TB4 on the tissue and nerve damage, as well as on the function of the sciatic nerve, is extremely encouraging and suggests a potential role for TB4 in the treatment of diabetic peripheral neuropathy in humans.  Moreover, the demonstration that reduction of glucose was not required to see the effects of TB4 is consistent with knowledge that reducing glucose levels does not ameliorate diabetic peripheral neuropathy.  In addition, these new data are consistent with prior robust findings that TB4 has potent neurovascular restorative effects for both neural injury and degeneration in the central and peripheral nervous systems," stated Michael Chopp, Ph.D., a member of the research team, Scientific Director of the Henry Ford Neuroscience Institute, and the Zoltan J. Kovacs Chair in Neuroscience Research.

"Since progressive loss of peripheral nerve function due to decreased nerve fibers and reduction in myelin is a major cause of morbidity in diabetes and in other conditions, these findings on the protective and restorative role of TB4 offer a significant potential new therapy for these patients. This study is very significant for RegeneRx as diabetic peripheral neuropathy is one of the targets for the use of RGN-352, our injectable TB4 formulation developed for systemic administration, and supports our continued investment in this area," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

The research was conducted by Dr. Lei Wang and her colleagues in the Department of Neurology at Henry Ford Hospital in Detroit, Michigan and the Department of Physics at Oakland University in Rochester, Michigan under a Material Transfer Agreement between Henry Ford Hospital and RegeneRx Biopharmaceuticals, Inc. The study was published in the Journal of Diabetes Research; 2015:173656. Doi: 10.1155/2015/173656, Epub 2015 Apr 7.

About Diabetic Peripheral Neuropathy

Diabetes affects an estimated 346 million people worldwide. Peripheral neuropathy is a progressive complication of diabetes and is associated with degeneration and demyelination of peripheral nerves.  There is currently no effective treatment for preventing the development or reversing the progression of diabetic neuropathy.  Symptoms can range from pain and numbness in the extremities to problems with the digestive system, urinary tract, blood vessels and heart and can be painful, disabling, and even fatal.

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

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and in the U.S. RGN-259, the Company's TB4-based ophthalmic drug candidate is being developed for dry eye syndrome and for the treatment of neurotrophic keratopathy (NK), both of which are being developed in the U.S through its joint venture, ReGenTree.  RGN-259 has been granted orphan status by the U.S. FDA and was recently allowed by the FDA to move into phase 3 clinical trials for the treatment of patients with NK.  RGN-352, the Company's TB4-based injectable drug candidate, is a phase 2-ready drug candidate designed to be administered systemically to prevent and restore tissue damage associated with acute events such as heart attacks, strokes, and other similar injuries.  RGN-137, the Company's TB4-based dermal gel, is in phase 2 clinical development. For additional information about RegeneRx please visit www.regenerx.com.

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SOURCE RegeneRx Biopharmaceuticals, Inc.

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