RegeneRx Licensee Administers RGN-137 to First Patient in Phase 2 EB Clinical Trial

ROCKVILLE, Md., May 29, 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 announced that GtreeBNT ('Gtree'), its licensee for RGN-137 topical wound healing gel, has initiated administration of the product candidate to the first patient in a randomized, single-masked, placebo-controlled, self-matched pairing, independently-evaluated phase 2 study for EB in the U.S.  RGN-137 is a formulation of thymosin beta 4 (Tβ4) designed for dermatological wound healing.  The clinical trial is being sponsored by Gtree's subsidiary joint venture company, Lenus. 

EB is a rare inherited connective tissue disease that causes blistering in the skin and in mucosal membranes resulting in difficult to treat wounds, skin fragility, and pain. EB is a serious disease with symptoms typically appearing in infancy and no available standard treatments beyond symptomatic relief.  There are an estimated 500,000 patients worldwide and 50,000 patients in both the U.S. and Europe where EB is designated an orphan disease.  The market size was approximately US$1.4 billion in 2017, according to Knowledge Sourcing Intelligence.

Until recently, the guidance from the FDA was not specific for EB and drug candidates required complete wound healing to be approved. This requirement made it very difficult to develop a treatment for EB. However, the FDA announced a separate guidance for the treatment of EB in June 2018 allowing partial wound healing to prove efficacy. This new guidance change has allowed more companies to consider developing treatments for EB.

The protocol of the current phase 2 trial was designed based on the new guidance by FDA, and the Company plans to conduct the next phase 3 trial on the basis of the results from the current phase 2 trial.

This trial is being conducted at five hospitals specializing in treating EB patients in the U.S.  Each patient will receive both placebo and active study drug, respectively, on two different wounds of similar stages. This allows every patient to receive drug treatment and for each patient to serve as their own control.  Specifically, the study was designed as an open study so that the data can be assessed and analyzed while conducting the clinical trial.

"The estimated number of EB patients is 500,000 worldwide and there is no cure for EB.  Patients with EB pay approximately $5,000 per a month for traditional wound treatments.  Even though EB is a rare disease, the treatment market size is large. We believe that RGN-137 will greatly help infants and children suffering from EB based on the results of this study," stated an official at Gtree.

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 ARISE-3, a follow-up Phase 3 trial in 700 patients with dry eye syndrome designed to confirm the positive results from ARISE-2.  ReGenTree is also sponsoring a 46-patient 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-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.

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, has initiated a small, open clinical trial in the U.S. for this indication.

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. There can be no assurance that any current or future animal studies or clinical trials, sponsored by the Company or its licensees, will start on time, be completed within a projection timeframe, or result in future value or approved products. There can also be no assurance that the Company or its licensees will apply for an NDA in the future or that if the Company or a licensee applies for an NDA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. or any other country. There can be no assurance that RegeneRx will be able to finance operations on a continual basis or through the completion of clinical development of its products by its licensees.  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.

SOURCE RegeneRx Biopharmaceuticals, Inc.

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