ROCKVILLE, Md., Aug. 14, 2017 : RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (the Company or RegeneRx), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that the European Patent Office (EPO) has issued an Intent to Grant notice related to Thymosin beta 4 (Tβ4) for use in the treatment of peripheral neuropathy.
Tβ4 is the active pharmaceutical ingredient in RegeneRx's proprietary drug candidate, RGN-352, a first-in-class product candidate designed for systemic administration to treat damaged tissue.

Peripheral neuropathy is a condition that develops as a result of damage to the peripheral nervous system, the communications network that transmits information between the brain and spinal cord to other parts of the body. Symptoms can range from numbness or tingling, to pricking sensations, muscle weakness and/or pain. It is estimated that 20 million people in the United States have some form of peripheral neuropathy, with a large number of patients in the EU, and is especially prevalent in patients with diabetes.

The patent will be issued to Dr. Michael Chopp and his colleagues at the Henry Ford Hospital System (HFHS) in Detroit, Michigan, and is the subject of a license agreement between RegeneRx and HFHS. Dr. Chopp and his team have published several scientific articles demonstrating that Tβ4 can ameliorate the effects of diabetic peripheral neuropathy in animal models of the disease. RegeneRx is responsible for all patent fees and commercialization of potential products. The patent will expire in December 2032.

"This patent continues to expand the scope of potential use of RGN-352, our systemic formulation of Tβ4, in patients with neural injury and peripheral nervous system disorders. The neurovascular remodeling, repair and regeneration properties of Tβ4 found by Dr. Chopp and his team in animal models expands the potential for the use of Tβ4 in major disorders such as peripheral neuropathy and other conditions or diseases that are associated with nerve damage. The granting of this patent, in addition to the U.S. patent application recently allowed on corresponding subject matter, will provide RegeneRx with a strong proprietary position with respect to the potential use of RGN-352 for the treatment of peripheral neuropathy, a large and underserved market," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

(Posted on 14 August 2017, 1675570683 3O236O47O240)