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05-Aug-2019

First Patient Enrolled in RGN-137 Trial for Epidermolysis Bullosa Experiences Complete Wound Healing

ROCKVILLE, Md., Aug. 5, 2019 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today confirmed that the first patient enrolled in a single-blinded, phase 2 clinical trial in patients with epidermolysis bullosa (EB) has positively responded to RGN-137, the Company's novel topically-administered drug candidate.

The trial is being sponsored by Lenus Therapeutics, LLC, a U.S. joint venture owned by both GtreeBNT and Yuyang DNU Co., Ltd., specifically to develop RGN-137 in the U.S., Canada, Europe, Korea, Japan, and Australia for dermal wound healing indications.  RGN-137 is being developed by the joint venture under a license from RegeneRx to GtreeBNT.

According to a statement released by Lenus Therapeutics, the first patient was enrolled, treated, and complete wound healing was achieved in the wound treated with RGN-137 but not in the wound treated with placebo.  Per the clinical protocol, the sponsor is aware of which product is being administered to each EB wound while the patient remains blinded.  Lenus further stated that the ongoing phase 2 clinical trial is proceeding well at five hospitals specializing in EB.

The ongoing clinical trial is a single-blinded study where two wounds are selected from each patient with one wound treated with placebo and the other with RGN-137 dermal gel. The design is an open study where the results can be confirmed for each patient in parallel with the clinical progression, although the patient is unaware of whether active or placebo is being used for each wound.

"The achievement of the complete healing in the first enrolled patient is very significant as the upcoming phase 3 study design will be based on the results of the current ongoing open study. The experiences and findings in the present study will provide the information for defining the clinical study design for the phase 3 study," stated an official at Lenus Therapeutics.

EB is a rare hereditary disease where the patients suffer from skin fragility. The skin is easily blistered due to gene mutations in proteins important in epidermal and dermal integrity, resulting in severe pain in both the skin and mucous membranes. There are approximately 500,000 patients worldwide with U.S. and European countries having approximately 50,000 patients. No specific treatment is currently available beyond supportive care, such as sterile dressing and antibiotics.

RGN-137 is targeted to be the first approved product for EB treatment based on its multiple mechanisms of actions, such as promotion of wound healing, cell protection, cell migration, and tissue integrity.

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, is sponsoring a follow-up phase 3 clinical trial (ARISE-3) in approximately 700 patients with dry eye syndrome (DES) designed to confirm statistically significant results from ARISE-2 a previous 600 patient clinical trial.  ReGenTree is also sponsoring a Phase 3 clinical trial in patients with neurotrophic keratopathy (NK).  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-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, initiated a small, open clinical trial in December 2018, in the U.S. for this indication.

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.  It may also have applications in patients with severe septic shock.

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. Forward-looking statements used in this press release relate to, among other things, the results and expected timing of clinical trials in the United States and the potential patient benefits of its product candidates. There can be no assurance that any proposed clinical trial will be completed within the estimated timeframe or that positive results from any clinical trials or research by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future commercial 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 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 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.

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SOURCE RegeneRx Biopharmaceuticals, Inc.

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Last Updated: 05-Aug-2019