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RegeneRx Announces First Patient Enrolled in Phase 3 U.S. Neurotrophic Keratopathy (NK) Clinical Trial with RGN-259

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Monday, September 21, 2015

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ROCKVILLE, Md. - RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced today that the first patient has been enrolled in a Phase 3 clinical trial with RGN-259 (designated GBT-201 in Korea), its sterile, preservative-free eye drop formulation developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders. The clinical trial is being sponsored by ReGenTree LLC, a joint venture between RegeneRx and GtreeBNT Co. Ltd. a Korean biopharmaceutical company and is being conducted by Ora Inc., an established contract research organization specializing in the field of ophthalmology.

This is the second late stage ophthalmic clinical trial with RGN-259 that has begun recently. On September 17th, RegeneRx announced that it began enrollment of a 350 patient multicenter Phase 2b/3 clinical trial in the U.S. in patients with dry eye syndrome.

The NK trial is a double-masked, placebo-controlled trial being conducted at eight sites, which include major U.S. medical centers. The trial will enroll approximately 46 patients with chronic stage 2 and 3 NK, and is expected to be completed by the end of the first quarter of 2016, or shortly thereafter. The primary endpoint is complete corneal healing in patients using RGN-259 compared to those using placebo. Patients will use the eye drops 5 times daily for 28 days and will be assessed periodically during treatment, upon completion of treatment, and at one week and two weeks post-treatment. There will be numerous secondary endpoints that will also be evaluated pursuant to the trial protocol.

"Enrollment of the first patient in our NK study marks another important milestone in the advancement of RGN-259, which we believe should be of significant value for this orphan indication in the U.S. and abroad. Positive results seen in NK patients that had previously failed all standards of care and then treated with RGN-259 supports our confidence that our product candidate can provide relief from this serious disorder," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

Thymosin beta 4 (TB4), the active ingredient in RGN-259, is a first-in-class, naturally occurring molecule that has been the subject of numerous published animal studies in the fields of ophthalmology, dermatology, cardiology, and central nervous system disorders, among others. In addition to the animal studies, the molecule has been tested in three unique formulations in approximately 350 patients and has an excellent safety profile.

About Neurotrophic Keratopathy
Neurotrophic Keratopathy (NK) is a serious degenerative disease of the corneal epithelium (the outside layer of the eye) that is designated an "orphan" disease in the U.S. and EU due to its relatively low prevalence. A reduction in corneal sensitivity or complete corneal anesthesia is the hallmark of this disease and is responsible for producing corneal ulceration, perforation, pain and impaired vision. NK typically has three stages: Stage 1 is characterized by mild, nonspecific signs and symptoms. The viscosity of the tear mucus increases. There is decreased tear break-up time, leading to dry spots on the epithelium. Stage 2 involves a non-healing corneal epithelial defect. The surrounding epithelium becomes loose and the stroma swells and becomes edematous. Characteristic of this stage, the defect forms a punched-out oval or circular shape. Stage 3 often ensues if stages 1 and 2 are not treated appropriately and is characterized by stromal melting leading to perforation and/or ulceration. Estimated U.S. and EU prevalence of all stages of neurotrophic keratopathy is less than 50,000 in each region and less than 10,000 with Stage 2 or 3.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, 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 China, Pan Asia (Korea, Japan, and Australia, among others) and the U.S., and has an extensive worldwide patent portfolio covering its products. RGN-259, the Company's TB4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy. RegeneRx was recently allowed by the FDA to move into Phase 3 clinical trials with RGN-259 for the treatment of patients with NK. The drug candidate is also being studied in patients with dry eye syndrome in the U.S. and Asia. RegeneRx, through its U.S. joint venture, ReGenTree LLC, is developing RGN-259 in the United States and expects to initiate a Phase 2b/3 trial in the third quarter of 2015. RGN-352, the Company's TB4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and restore tissue damage associated with acute events such as heart attacks, strokes, and other similar traumatic injuries. 

About ReGenTree LLC
ReGenTree is a newly created U.S. joint venture company owned by G-treeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259/GBT-201 in the U.S. for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in January of 2015 and is initiating Phase 2b/3 and Phase 3 clinical trials in patients with dry eye syndrome and neurotrophic keratopathy (an orphan indication) in September 2015. Results from the trials are expected in March/April 2016. RegeneRx retains a significant minority interest in the joint venture, along with a royalty on commercial sales, and is represented on the board of ReGenTree. Certain commercial and financial transactions require RegeneRx approval. G-treeBNT is responsible for operations of the venture and all funding required for clinical development of RGN-259/GBT-201 in the U.S.

Contact
Lori Smith, 301.208.9191
las@regenerx.com

Investor
Stephanie Prince
PCG Advisory Group
646.762.4518
Sprince@pcgadvisory.com

Media
Sean Leous
PCG Advisory Group
646.863.8998
Sleous@pcgadvisory.com

Source: RegeneRx Biopharmaceuticals, Inc.
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