RegeneRx Licensee Receives FDA Permission to Conduct a Phase 3 Trial of RGN-137 for Epidermolysis Bullosa in U.S.

ROCKVILLE, Md., Feb. 27, 2017 /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 its licensee for RGN-137, GtreeBNT Co., Ltd., received a positive response from the U.S. FDA for its Phase 3 clinical trial design for RGN-137 to treat epidermolysis bullosa ("EB"). RGN-137 is a dermal wound healing gel that incorporates Thymosin beta 4 ("Tβ4") as the active pharmaceutical ingredient. GtreeBNT is planning to enter into the Phase 3 trial in the U.S. during the third quarter of 2017. 

EB is a rare inherited skin disease that is caused by genetic defects in anchoring between the epidermis and dermis, resulting in skin fragility. EB patients develop recurrent blisters and scars in the skin throughout the body beginning at birth, which can lead to serious infections, severe pain, and sometimes death. RGN-137 previously received an orphan designation for EB from the U.S. FDA. 

It is estimated that the number of patients with all types of EB is approximately 25,000 to 30,000 in the U.S. The global market size of EB treatment is estimated at approximately $1.0 billion annually.  Since there is currently no approved prescription treatment for EB, RGN-137 is targeting a very significant unmet medical need. The current treatments available for EB primarily focus on minimizing and relieving certain of its symptoms and controlling infection. RGN-137 has the potential to reduce pain and suffering in EB patients by accelerating wound healing, reducing inflammation, and upregulating the production of laminin-5, a protein that affects tissue integrity throughout the body that is defective in patients with EB. RGN-137 has also been shown to reduce scarring in animal models, another problem affecting EB patients.

"Since we received an official positive response from the FDA for our clinical development plan for a Phase 3 EB trial, our clinical development plan for the treatment of EB with RGN-137 has been established. GtreeBNT now has the potential to move forward for an NDA submission. Furthermore, this agreement with the FDA has continued our momentum in developing new drugs to treat rare diseases," stated Won S. Yang, president and chief executive officer of GtreeBNT.

The Phase 3 trial will be a randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of RGN-137 topically administered to approximately 200 EB patients at clinical sites throughout the U.S. GtreeBNT will be sponsoring and funding the clinical trial.

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, neuro, 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 Tβ4-based ophthalmic drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In March 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome (DES). The dry eye trial results were announced in May 2016 and ReGenTree has subsequently begun enrollment in a second Phase 3 DES trial in approximately 500 patients. ReGenTree is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK. RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. In addition to development of RGN-137 through a license to GtreeBNT in the U.S., 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 damage associated disorders such as multiple sclerosis and traumatic injuries such as stroke. For additional information about RegeneRx please visit www.regenerx.com.

About GtreeBNT:

GtreeBNT Co., Ltd. (www.gtreebnt.com) is a clinical development pharmaceutical company listed on the Korean stock market that aims to acquire the rights to early clinical stage pipeline pharmaceuticals targeted at diseases with unmet needs, including rare diseases. GtreeBNT plans to rapidly develop the pharmaceuticals through additional studies, formulation development, and clinical trials for commercialization. Currently, its U.S. subsidiary, ReGenTree, LLC (www.regentreellc.com), is conducting a second Phase 3 clinical trial (ARISE-2) for dry eye syndrome (DES) and a Phase 3 trial (SEER-1) for the orphan ocular disease neurotrophic keratopathy (NK) using RGN-259 eye drops. In addition, GtreeBNT is conducting a Phase 1b trial for the orphan disease glioblastoma multiforme (GBM) using OKN-007 in U.S.

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 proposed EB clinical trial will be initiated and/or completed in the targeted time-frame or result in a positive outcome, approved products or future value. 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, 2015, 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 or its licensees' expectations only as of the date of this release and should not be relied upon as representing its expectations 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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