The intellectual property was developed at the Henry Ford Hospital System, Detroit, Michigan, by Drs. Michael Chopp, Daniel Morris, and Zhenggang Zhang, and in-licensed by RegeneRx Biopharmaceuticals, Inc. The patent expiry is 2030, not including any potential extensions.
"We believe that this is an important patent and a significant addition to our central nervous system (CNS) intellectual property portfolio," said J.J. Finkelstein, RegeneRx’s president and chief executive officer.
"We expect that our proprietary technology will be further enhanced as we identify strategic partners with whom we can continue the development of RGN-352, our systemic formulation of TB4 to treat CNS disorders."
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 the U.S., and has an extensive worldwide patent portfolio covering its products.
RGN-259, the Company’s TB4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy (NK), which is a primary focus of RegeneRx’s clinical development efforts in the U.S through its joint venture, ReGenTree. RegeneRx was recently allowed by the FDA to move into Phase 3 clinical trials with RGN-259 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.