ROCKVILLE, Md., Nov. 16, 2017 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that Thymosin beta 4 (Tβ4), the active ingredient in RGN-259, a preservative-free ophthalmic eye drop, was the subject of a Keynote Address at the 5th International Symposium of Thymosins in Health and Disease in Washington, DC.
The presentation was given by Dr. Gabriel Sosne, an award-winning clinician scientist, Associate Professor in Ophthalmology and Anatomy and Cell Biology at Wayne State University School of Medicine, and a clinician at the Kresge Eye Institute in Detroit, MI. Dr. Sosne has spent over fifteen years studying the role of Tβ4 in ophthalmic diseases and treatment and is on the scientific advisory board of the Company.
In his talk, Dr. Sosne presented data demonstrating Tβ4's important role in corneal wound healing at the benchtop and in his clinical experiences. He described the diverse populations afflicted with dry eye and how Tβ4's properties have significant clinical relevance for these patient populations. Dr. Sosne also highlighted other potential eye disorders, including blepharitis, neurotrophic keratopathy, and graph vs. host disease, as well as post-surgical care, that would potentially benefit from RGN-259 due to the inflammatory and wound healing components of their etiology.
In October, RegeneRx's U.S. joint venture, ReGenTree, LLC, released results from its most recent phase 3 trial (ARISE-2) in 600 patients with moderate to severe dry eye syndrome. The ARISE-2 trial demonstrated a number of statistically significant improvements in both signs and symptoms of dry eye syndrome with RGN-259 versus placebo, while showing excellent safety, comfort, and tolerability profiles. ReGenTree is proceeding with a development plan for the next step and intends to meet with the FDA in the first quarter of 2018. ReGenTree is also sponsoring a phase 3 clinical trial in patients with chronic neurotrophic keratopathy, an orphan ophthalmic disorder commonly caused by the herpes zoster virus.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
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 eye drops, is currently the subject of phase 3 clinical trials for patients suffering from dry eye syndrome as well and for patients having chronic neurotrophic keratopathy (NK), a non-healing corneal lesion designated an orphan indication in the U.S.
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 peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke.
RGN-137, also designated an orphan drug in the U.S., is the Company's Tβ4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition by the Company's licensee, GtreeBNT.
For additional information about RegeneRx please visit www.regenerx.com.
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that any past, current or future research or clinical trials will result in approved products or future value. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.