ROCKVILLE, Md., Jan. 21, 2020 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, reported today that the Korean Intellectual Property Office has issued a new patent to the Henry Ford Health System (HFHS) for a Thymosin beta 4 (Tβ4) composition for reducing diabetic-induced vascular dysfunction. Tβ4 is the active pharmaceutical ingredient in RegeneRx's proprietary drug candidate, RGN-352, a first-in-class injectable formulation designed for systemic administration for tissue regeneration and repair.
RegeneRx in-licensed the intellectual property relating to the use of Tβ4 for this indication from HFHS in Detroit, MI based on work performed by Dr. Michael Chopp and his colleagues under a Material Transfer Agreement. The patent will expire in December of 2032.
According to the Diabetes & Metabolism Journal, the prevalence of type 2 diabetes mellitus (T2DM) is increasing in Korea and has escalated from 1.5% to 9.9% [approximately 5.1 million people] over the last four decades. Major outcomes of the progression of T2DM include chronic complications that decrease quality of life (QoL), incur heavy burdens on the healthcare system, and increase diabetic mortality. Diabetic peripheral neuropathy (DPN) is the most common complication associated with diabetes and it is estimated that 30% to 50% of diabetes patients are affected by this disorder.
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, four active strategic licensing agreements in the U.S., China, Pan Asia (Korea, Japan, and Australia, among others), and the EU and has patents and patent applications covering its products in many countries throughout the world. RGN-352, the Company's injectable formulation of Tβ4, has successfully completed phase 1 clinical trials and is phase 2-ready. RGN-259, the Company's ophthalmic eye drop, is currently in Phase 3 clinical trials for dry eye syndrome and neurotrophic keratopathy and RGN-137, the Company's dermal gel, is in phase 2 clinical trials for epidermolysis bullosa, both of which will have data read-outs this year.
For additional information about RegeneRx please visit www.regenerx.com.
Forward Looking Statements
Any statements in this shareholder letter 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 in this release include, but are not limited to, patents, know-how, statements regarding our strategic and research partnerships, clinical trials, regulatory applications and approvals, and the use of our drug candidates to treat various conditions. All forward-looking statements are expectations and estimates based upon information obtained and calculated by the Company at this time and are subject to change. Moreover, there is no guarantee any issued patents will provide exclusivity or will not be challenged in a particular jurisdiction, or that any clinical trial will be successful or confirm previous clinical results. 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 shareholder letter 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.