RegeneRx Receives Notice of Allowance of U.S. Patent for Treatment of Corneal Wounds

ROCKVILLE, Md., March 14, 2018 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent for treating corneal wounds using Thymosin beta 4 (Tβ4) or related therapeutic peptides.  Tβ4 is the active pharmaceutical ingredient in RegeneRx's proprietary drug candidate, RGN-259, a first-in-class, preservative-free, eye drop designed for patients suffering from a broad spectrum of corneal wounds. 

Corneal wounds can occur from refractive surgeries such as Lasik, eye disorders such as diabetic keratopathy and dry eye syndrome, and traumatic injuries related to abrasions and burns.   Infections, as well as contact lenses, can also play a role in the development of corneal wounds.  A simple-to-use, safe and effective eye drop to treat such wounds would address a significant unmet medical need.

RegeneRx has licensed the U.S. rights to RGN-259, currently in phase 3 clinical trials in the U.S., to ReGenTree, LLC, a joint venture between GtreeBNT and RegeneRx.  RegeneRx retains full ownership of the intellectual property and knowhow related to RGN-259 in the EU.

"We believe this patent will complement our recently issued dry eye patent by expanding our intellectual property portfolio in the ophthalmic field and benefit our ReGenTree JV as it continues to develop products to treat various eye injuries and disorders," stated J.J. Finkelstein, president and chief executive.    

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, recently completed patient enrollment and treatment in its second Phase 3 clinical trial in approximately 600 patients with dry eye syndrome, reported positive clinical results with no safety issues, and has scheduled a meeting with the U.S. FDA in April 2018.  ReGenTree is also conducting a 46-patient Phase 3 clinical trial in patients with neurotrophic keratopathy (NK) targeted for completion in 2018.  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-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.  

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. The Company's licensee, GtreeBNT, is sponsoring a phase 3 clinical trial in the U.S. and is expected to initiate the study in 2018.

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. There can be no assurance that any notices or patents issued by any government patent authority in any country, or licenses held by the Company, or patent applications filed by the Company, including this most recent issued patent for dry eye syndrome in the United States, or any current or future clinical trials will result in approved products or future value. 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, 2017, 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.

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