Researchers Confirm Thymosin Beta 4's Ability to Protect Eyes From Ethanol Injury

ROCKVILLE, Md., Jan. 25, 2022 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration), today announced that Chinese researchers confirmed the ability of Thymosin beta 4 (Tβ4) to protect corneal stromal cells from damage due to ethanol exposure and significantly promote wound healing. Ethanol is used in ophthalmic surgeries to sterilize the eye for surgeries such as LASEK and PRK and can cause damage such as apoptosis (cell death), inflammation, and extend healing time.

The corneal stroma plays a significant role in maintaining corneal shape and curvature, and corneal transparency. Corneal stroma wound healing is a complex process and an efficient repair process is vital. The research team demonstrated the protective effects of using Tβ4 in both in vivo and in vitro animal models.

"This is an excellent paper confirming and extending the previous research of Dr. Gabe Sosne. It is always important for independent researchers to confirm original findings and gives additional rationale for the development of RGN-259 for ophthalmic conditions where injury and/or inflammation play critical roles in the healing process and patient discomfort," stated Dr. Allan L. Goldstein, RegeneRx's chief scientific officer.

The research was published by Liu et al., in BMC Ophthalmology (2022) 22:33, https://doi.org/10.1186/s12886-022-02255-8.

RGN-259 is a sterile, preservative-free eye drop with Tβ4 as the active ingredient, that in controlled clinical trials has been shown to quickly reduce certain signs and symptoms of dry eye syndrome and neurotrophic keratitis and having no significant side effects that are commonly associated with other products. The product candidate has completed three phase 3 clinical trials in patients with dry eye syndrome and is moving through the FDA regulatory process through the Company's ReGenTree LLC U.S. joint venture.

About RegeneRx Biopharmaceuticals, Inc.

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/neuro and dermal indications, four active strategic licensing agreements in the U.S., China, and 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.

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. Forward-looking statements in this press release include but are not limited to statements from us or within research published by third parties. There can be no assurance that positive results from any research or clinical trial by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view 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, 2020, 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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