RegeneRx Biopharmaceuticals, Inc. (“RegeneRx” or the “Company”) (OTCQB: RGRX) is a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tß4, for tissue and organ protection, repair, and regeneration. We have formulated Tß4 into three distinct product candidates in clinical development:
RegeneRx holds numerous issued patents and patent applications, itself or through its partners, worldwide in order to enable and protect multiple indications and applications for its product candidates.
Currently, RegeneRx has active partnerships in four major territories around the world: the U.S. and Canada, China, Pan Asia, and the EU. Our partners have been moving forward and making significant progress in each territory with RGN-259, our ophthalmic drug candidate, and have initiated Phase 2 and Phase 3 clinical trials in several ophthalmic and dermal medical indications. In each case, the cost of development is being borne by our partners with no financial obligation for RegeneRx. Patient accrual, treatment, and follow-up for the ophthalmic trials are relatively fast, as opposed to most other clinical efforts, so data is typically forthcoming in months after patients begin enrollment.
We have other significant clinical assets to develop, primarily RGN-352 (injectable formulation of Tβ4 for cardiac and CNS/PNS disorders) in the U.S., Pan Asia, and Europe, and RGN-259 in the EU. With respect to RGN-259, our goal is to wait until Phase 3 is completed in the U.S. before moving into the EU with RGN-259 in order to maximize value for the EU market. We intend to continue to develop RGN-352, either by obtaining grants to fund a Phase 2a clinical trial in the cardiovascular or central nervous system fields or finding a suitable partner with the resources and capabilities to develop it as we have with RGN-259.