RegeneRx Partner Receives Patent for New Ophthalmic Formulation of Thymosin Beta 4

ROCKVILLE, Md., May 16, 2019 /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 its U.S. joint venture partner and Pan Asian licensee, GtreeBNT, has been granted a new U.S. patent for a method of preventing or treating dry eye syndrome by administering Tβ4 with non-active ingredients to provide improved pharmacodynamics.  Tβ4 is the active component of RGN-259, currently in separate phase 3 clinical trials for dry eye syndrome and neurotrophic keratitis.  The expiry of this new patent is 2035.

"We are pleased that Gtree has been granted another patent related to Tβ4 in the ophthalmic field emanating from its comprehensive development of RGN-259, our sterile, preservative-free eye drop solution.  New intellectual property, such as patents and know-how developed under our licenses to Gtree and our U.S. joint venture, ReGenTree LLC, expands and extends the IP portfolio underlying these licenses," stated J.J. Finkelstein, president and chief executive officer.    

Dry eye syndrome is a common condition affecting millions of people throughout the world.  It is a multi-factorial disorder where loss of homeostasis of the tear film results in pain, itching, blurry vision, and dryness, among other symptoms. RGN-259 eye drops contain an active small protein, thymosin beta 4, which is naturally occurring in tears and other body fluids.  RGN-259 eye drops have demonstrated wide-ranging and multifunctional activities.  Such activities underlie the efficacy of RGN-259 eye drops seen to date in alleviating both the signs and symptoms of dry eye. 

RGN-259 eye drops are safe and well-tolerated by patients, and in both ARISE-1 and ARISE-2 clinical trials, patients reported minimal ocular discomfort similar to that of the placebo.  RGN-259 is currently the subject of a 700-patient phase 3 clinical trial in the U.S, ARISE-3.

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 ophthalmic eye drop, is currently in Phase 3 clinical trials for dry eye syndrome and neurotrophic keratopathy.

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 shareholder letter include, but are not limited to, patents, know-how, competitive products, statements regarding our strategic and research partnerships, clinical trials, regulatory applications and approvals, the development and value of our drug candidates, 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.

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