Clinical Trial Demonstrates Elevated Thymosin Beta 4 Plasma Levels are Associated with Improvement of Symptoms After Stem Cell Therapy in Patients with Ischemic Heart Failure

ROCKVILLE, Md., June 2, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx") today announced a peer-reviewed publication of the results of a recent cardiac stem cell clinical trial that demonstrates the potentially key role that Thymosin beta 4 (TB4) plays in the functional repair of cardiovascular disease. The REGENERATIVE-IHD trial is the largest, randomized, placebo-controlled clinical trial in the UK, to date, which was designed to investigate the use of autologous bone marrow-derived stem cells to improve cardiac function and symptoms in heart failure patients.  As part of the trial, the authors studied a cohort of patients to determine if TB4 levels were affected by injection of stem cells and whether this had a correlation with clinical improvement. Serial plasma TB4 levels were obtained from patients and concentrations were measured in those who received stem cells and those who did not.  According to the authors, "There was a significant increase in circulating levels of TB4 [in the stem cell-injected responder group only] 24 hours after intracardiac injection, which was directly associated with improvement in cardiac symptoms 6 months post-treatment."

"This is a very important study as it provides the first human evidence documenting an important role for TB4 in improving heart function in patients with ischemic heart failure, which has previously only been seen in animal models, and the potential role TB4 may play as an essential factor in mediating cardiovascular  repair," according to Dr. Allan L. Goldstein, Professor Emeritus of Biochemistry and Molecular Medicine at The George Washington University and RegeneRx's Chairman and Chief Scientific Advisor.

The study was conducted by Dr. F.A. Choudry and his colleagues in the Department of Cardiology, London Chest Hospital, Barts Health Trust; the British Heart Foundation Laboratories, Department of Medicine, University College and Centre for Clinical Pharmacology, Cardiovascular Biomedical Research Unit; and The William Harvey Research Institute, Queen Mary University, all located in London, UK.  The research paper is published in the current edition of Regenerative Medicine (2015) 10(4), 403–410.

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 (NK).  RegeneRx was recently allowed by the FDA to move into Phase III 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 IIb/III trial later this year. RGN-352, the Company's TB4-based injectable, 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.  For additional information about RegeneRx please visit www.regenerx.com.

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SOURCE RegeneRx Biopharmaceuticals, Inc.

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