ROCKVILLE, Md., Nov. 2, 2016 /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 it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a single unit dosage eye drop formulation containing Thymosin beta 4 (Tβ4). Tβ4 is the active pharmaceutical ingredient in RGN-259, RegeneRx’s preservative-free eye drops currently in Phase 3 clinical trials.
Claims covered under this patent include RGN-259 formulations as a single unit dosage eye drop for any applicable indication. The patent expiry is June 19, 2026, not including any extensions that may be available through the USPTO.
“We believe this is an important U.S. patent that continues to be part of our strategy to broaden our exclusivity for the potential administration of RGN-259 eye drops in patients with corneal injuries and inflammation resulting from dry eye and other ophthalmic disorders. We are pleased patent applications for our technologies, some of which were initially filed years ago, continue to be granted in the U.S. and around the world,” stated J.J. Finkelstein, RegeneRx’s president and chief executive officer.
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 drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In March 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome. The dry eye trial results were announced in May 2016 and ReGenTree has subsequently received permission from the U.S. FDA and initiated a second Phase 3 trial in approximately ~500 patients. The Company is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK. RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx’s two Asian partnerships. 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 multiple sclerosis and traumatic injuries such as stroke. 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 notices or patents issued by the USPTO, or licenses held by the Company, or patent applications filed by the Company, including this most recent Notice of Allowance in the U.S., 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, 2015, 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.