RegeneRx (OTCQB: RGRX) is a clinical-stage biopharmaceutical company with a large, growing patent portfolio that protects multiple indications and applications for its product candidates. At the heart of its IP strategy is Thymosin Beta 4 (Tβ4), a naturally occurring peptide found to play a vital role in protection, regeneration and remodeling of damaged tissues. RegeneRx is currently moving three distinct Tβ4-based drug candidates through clinical development for ophthalmic, cardiac and dermal indications. The company recently received notice of Intent to Grant a patent from the European Patent Office for treating neural injury using Tβ4. More recently, the company received patent approval from the Australian Patent Office regarding Tβ4, the active pharmaceutical ingredient in proprietary drug candidate RGN-352, to myelinate damaged brain nerve cells. Company CEO J.J. Finkelstein, in a recent news release, noted that the Australian patent supports the potential use of RGN-352 for major disorders such as multiple sclerosis (MS), as well as other conditions associated with demyelination. Active partnerships are also a key component of the company’s business strategy, which covers three major territories: the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others). The company’s licensing partners are focused on saturating each respective territory with RGN-259, and are preparing to initiate their clinical trials programs.
To learn more, visit www.regenerx.com
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, 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 the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world. RGN-259, the Company’s Tβ4-based ophthalmic drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In March 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome (DES). The dry eye trial results were announced in May 2016 and ReGenTree has subsequently begun enrollment in a second Phase 3 DES trial in approximately ~500 patients. The Company is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK. RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx’s two Asian partnerships. RGN-352, the Company’s Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue damage associated disorders such as multiple sclerosis and traumatic injuries such as stroke.
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