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RegeneRx JV Partner Updates on Strategic Dry Eye Discussions

GtreeBNT Meets with Multinational Pharma Companies at AAO in Anticipation of Completion of Phase 3 Clinical Trial


News provided by

RegeneRx Biopharmaceuticals, Inc.

Oct 16, 2019, 08:17 ET

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ROCKVILLE, Md., Oct. 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, released a summary of its U.S. joint venture partner, GtreeBNT's, recent attendance at the American Academy of Ophthalmology meeting (AAO) in San Francisco, California. The following summary was provided to RegeneRx by GtreeBNT and is posted on Gtree's web site:

The Gtree team, including CEO Won S. Yang, had numerous meetings regarding its dry eye drug candidate, RGN-259, which is being developed by ReGenTree, LLC (the U.S. joint venture between Gtree and RegeneRx). These meetings took place with several multinational pharmaceutical companies and key U.S. dry eye experts during the AAO meeting held in San Francisco, California on October 12-15. The meetings went well and most of the meeting participants expressed high interest in the significant clinical results with RGN-259 in the previous ARISE-2 dry eye trial, as well as the potentially strong business opportunities that would be likely if such results are reproduced in ARISE-3 (ReGenTree's phase 3 dry eye clinical trial). ARISE-3 is progressing smoothly and GtreeBNT will continue discussions with potential strategic partners as the clinical trial moves closer toward completion in the Summer of 2020.

"We are pleased that the AAO meetings were successful and that several multinational pharma companies continue to express a strong interest in RGN-259 as a potential treatment for dry eye syndrome, as well as other corneal-related disorders. As we get closer to completion of ARISE-3, we would expect such talks to intensify and look forward to the successful advancement of our RGN-259 development program and potential returns to our long-standing investors," stated J.J. Finkelstein, president and chief executive officer.

Dry eye syndrome is a common multi-factorial condition affecting millions of people throughout the world. DES is a 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. Moreover, RGN-259 eye drops are safe and well-tolerated by patients, and in both ARISE-1 and ARISE-2 patients reported minimal ocular discomfort similar to that of the placebo.

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 in the U.S.

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 include, but are not limited to, competitive products, statements regarding our strategic and research partnerships and meetings, status of 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 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.

Related Links

http://www.regenerx.com

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