ROCKVILLE, Md., Nov. 18, 2019 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or the "Company"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced the publication of a new scientific study demonstrating the protective effect of Thymosin beta 4 (Tβ4) in an ischemic acute kidney injury model in laboratory rats.
In this study, researchers reported that administration of Tβ4 to animals with induced kidney injury significantly reduced ischemic acute kidney injury. In addition, metabolic studies demonstrated that Tβ4 appears to work by reduction of inflammation, inhibition of the extracellular remodeling process, and suppression of the apoptosis cascade (cell death) via modulation of renal redox status.
"This paper validates the tissue protection and repair properties of Tβ4 in the kidney as previously demonstrated by research teams around the world in the heart, liver, lungs and brain. What is new in this paper is that Tβ4 also appeared to modulate renal redox status (the balance of specific biological processes affecting normal kidney function). This new finding gives us exciting new insight into understanding the potential of Tβ4 in wound healing and tissue repair of the kidney," stated Dr. Allan Goldstein, Emeritus Professor of Biochemistry and Molecular Science at The George Washington University School of Medicine and Chief Scientific Advisor at RegeneRx Biopharmaceuticals.
The research was performed by Dr. Ugur Aksu et. al at the Department of Biology, Istanbul University; Department of Physiology, Istanbul University-Cerrahpasa; Department of Histology and Embriology, Istanbul University-Cerrahpasa; Institute of Health Sciences, Genetics Istanbul University; Department of Biochemistry, Cerrahpasa Medical Faulty, Istanbul University-Cerrahpasa, Istanbul, Turkey; and Department of Nursery, School of Health, University of Kırklareli, Kırklareli, Turkey. The article was published online in the Journal of Investigative Surgery, 08/11/2019, https://doi.org/10.1080/08941939.2019.1672841. The research was performed under a Material Transfer Agreement with RegeneRx Biopharmaceuticals, Inc.
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.
RegeneRx, through its U.S joint venture, ReGenTree LLC, is sponsoring a follow-up phase 3 clinical trial (ARISE-3) in approximately 700 patients with dry eye syndrome (DES) designed to confirm statistically significant results from ARISE-2 a previous 600 patient clinical trial. ReGenTree is also sponsoring a Phase 3 clinical trial in patients with neurotrophic keratopathy (NK). Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-259 has been designated an orphan drug in the U.S. for the treatment of NK.
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 causing blistering, non-healing wounds. The Company's licensee, GtreeBNT, initiated a small, open clinical trial in December 2018, in the U.S. for this indication. The first patient treated in the trial had complete healing of the target lesion.
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 disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke. It may also have applications in patients with severe septic shock.
For additional information about RegeneRx please visit www.regenerx.com.
Forward-Looking Statements
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. Forward-looking statements used in this press release relate to, among other things, research results under material transfer agreements published by third parties and the expected timing of clinical trials in the United States and abroad. There can be no assurance that positive results from any research or clinical trial by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2018, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. 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.
SOURCE RegeneRx Biopharmaceuticals, Inc.
