thymosin beta 4

ROCKVILLE, Md., April 13, 2023 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, has announced that on April 12, the first patient of the Phase 3 clinical trial (SEER-2) of RGN-259, a novel treatment for neurotrophic keratitis (NK), has been enrolled and begun treatment. The product candidate is under development by ReGenTree, LLC, a U.S. joint venture between RegeneRx and HLB Therapeutics. Clinical results in patients with NK treated with RGN-259 have previously demonstrated efficacy in a small number of patients (18) in the first phase 3 clinical trial (SEER-1), and two clinical trials are underway simultaneously in the United States and Europe based on these results. Two independent clinical trials showing statistically significant safety and efficacy are required for marketing approval in the U.S. ReGenTree aims to significantly shorten the clinical development period by conducting the two phase 3 clinical trials (SEER-2 and SEER-3) at the same time, rather than sequentially. The double-masked, placebo-controlled trials will be conducted by administering RGN-259 or placebo eye drops for four weeks to approximately 70 NK patients in each trial, with a primary endpoint of "complete corneal healing." Considering it is a rare disease, ReGenTree plans to recruit more than 30 clinical institutions in the U.S. to accelerate patient recruitment. RGN-259, whose active ingredient is thymosin beta 4 (Tβ4), is a novel drug candidate that promotes cell migration, anti-inflammation, and wound healing. RGN-259 is formulated as a sterile, preservative-free eyedrop and has been shown to be safe and well-tolerated. Neurotrophic keratitis offers a relatively large market opportunity as a rare disease with about 20,000 patients a year in the United States. Oxervate, from Dompé farmaceutici in Italy, is currently the only approved treatment for NK in the United States and is one of the most expensive pharmacy drugs in the U.S. Regarding the clinical development of RGN-259 for dry eye syndrome, HLB Therapeutics noted that ReGenTree applied for SPA (Special Protocol Assessment) to the FDA in October of 2022, and has since been closely discussing clinical design, statistical analysis plans, and approval requirements with the FDA. SPA is a system whereby a sponsor consults with FDA in advance on clinical protocols and statistical analysis plans to increase the possibility of new drug approval. According to HLB, its strategy is to increase clinical design completeness and reduce uncertainty in the future as it believes RGN-259 will be an important clinical product for dry eye treatment given its past clinical results. 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. This press release has been prepared based on information provided primarily by HLB Therapeutics. Forward-looking statements in this press release include but are not limited to statements from us, our partners, or within research published by the Company or unaffiliated third parties. There can be no assurance that any proposed clinical trials will be initiated, completed, or confirm previous results. 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, 2022, 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. Company Codes: OTC-QB:RGRX, OTC-PINK:RGRX, OTC-BB:RGRX

ROCKVILLE, Md., April 11, 2023 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, has issued a Letter to Stockholders updating its ongoing operating strategy. The Letter may be viewed at RegeneRx's homepage: . 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, acute inflammatory 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 and Letter to Stockholders 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 stockholder letter include, but are not limited to, statements regarding our current or future cash position, capital requirements, ability to continue operations, strategic and research partnerships, the development and timing of clinical trials for our drug candidates, the use of our drug candidates to treat various conditions, our operating strategies, intellectual property, and our financial needs. These, and any other forward-looking statements, are expectations and estimates based upon information obtained from our joint venture partner and/or calculated by the Company at this time and are subject to change. Moreover, there is no guarantee any of our clinical trials will be successful or confirm previous clinical results. There also is no assurance that we can successfully raise the capital required to continue even limited business operations now or in the future. 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, 2022, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC, if any. Any forward-looking statements in this stockholder letter represent the Company's views only as of the date of this letter 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.

ROCKVILLE, Md., April 11, 2023 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, has issued a Letter to Stockholders updating its ongoing operating strategy. The Letter may be viewed at RegeneRx's homepage: . 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, acute inflammatory 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 and Letter to Stockholders 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 stockholder letter include, but are not limited to, statements regarding our current or future cash position, capital requirements, ability to continue operations, strategic and research partnerships, the development and timing of clinical trials for our drug candidates, the use of our drug candidates to treat various conditions, our operating strategies, intellectual property, and our financial needs. These, and any other forward-looking statements, are expectations and estimates based upon information obtained from our joint venture partner and/or calculated by the Company at this time and are subject to change. Moreover, there is no guarantee any of our clinical trials will be successful or confirm previous clinical results. There also is no assurance that we can successfully raise the capital required to continue even limited business operations now or in the future. 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, 2022, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC, if any. Any forward-looking statements in this stockholder letter represent the Company's views only as of the date of this letter 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. View original content: SOURCE RegeneRx Biopharmaceuticals, Inc. Company Codes: OTC-QB:RGRX, OTC-PINK:RGRX, OTC-BB:RGRX