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RegeneRx to Shift Ophthalmic Clinical Development Strategy.

Principal Investigator Seeks to Expand "Compassionate Use" Study

BETHESDA, Md. -- REGENERX BIOPHARMACEUTICALS, INC. (NYSE Alternext US:RGN) announced today that based on encouraging "Compassionate Use" data showing RGN-259's potential healing effects in patients with non-healing corneal ulcers, the company will close its current double blind, placebo controlled, Phase II clinical trial targeting a small subset of diabetic patients undergoing vitrectomy (DV) surgery in order to focus on a patient population with broader market potential.

The small proof-of-concept DV trial had been enrolling slowly due to newer surgical procedures that have resulted in a decreasing number of vitrectomy procedures in the U.S. where partial removal of the corneal surface is required. The trial has completed patient treatment with the lowest dose of RGN-259. These patients will be evaluated as part of the trial closure, which is expected to take approximately 60 days to complete. There have been no reported drug related adverse events. The company estimates it will save approximately $1.8 million in future costs associated with the DV trial.

The company is also reporting that Dr. Steven Dunn, the principal investigator holding the "Compassionate Use" IND, has sought permission from the Institutional Review Board to expand enrollment to ten patients, allow a longer treatment period if necessary, and include patients with punctate keratitis (numerous small corneal wounds commonly affecting comfort and vision). The patients will be evaluated for both corneal healing and improved visual acuity. On November 17, 2008, the company reported that RGN-259 had been used to treat four patients with non-healing eye ulcers for 28 days with "striking" results according to Dr. Dunn.

"Now that we have seen the clinical activity of RGN-259 in neurotrophic keratopathy patients receiving treatment for their corneal ulcers, we believe it makes sense to close the diabetic vitrectomy trial and seek to focus on a larger commercial opportunity. Supporting data from both studies may allow RegeneRx to accelerate the clinical development of RGN-259 by conducting a Phase II/III trial and, if warranted, requesting 'fast track' status for marketing approval by the FDA," stated David Crockford, vice president of clinical and regulatory affairs.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. RegeneRx is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on T4, a synthetic copy of a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides and is currently sponsoring three Phase II chronic dermal wound healing clinical trials (one of which was recently completed), a Phase II ophthalmic clinical trial that is the subject of this press release, and a Phase I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications.

RegeneRx Technology Background

T4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. RegeneRx has identified several molecular variations of T4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions throughout the U.S., have published numerous scientific articles indicating T4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to T4's effects in the eye have been published in Investigative Ophthalmology and Visual Science, Experimental Cell Research, and Experimental Eye Research, among others. Abstracts of these and other scientific papers related to T4's mechanisms of action may be viewed at RegeneRx's web page:

Forward-Looking Statements

This press release contains certain forward-looking statements that 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. Examples of such forward-looking statements include statements concerning the projected cost savings from closing the RGN-259 DV trial, the size of the market for any alternative ophthalmic indications that the company may elect to focus on, including non-healing neurotrophic keratitis ulcers, the expansion of enrollment in the compassionate use study from four to ten patients and the inclusion of patients with corneal punctuate keratitis in the compassionate use study, the potential impact of the closing of the DV trial on the speed of the development or commercialization of RGN-259, requests to conduct a Phase II/III clinical trial involving RGN-259 or to request "fast-track" status for RGN-259, the safety and efficacy of RGN-259, the company's ability to enter into any collaborations with respect to the development or commercialization of any of its product candidates, and the therapeutic potential of T4 for dermal, ophthalmic, and cardiovascular wounds and pulmonary indications. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that the compassionate use results were based on a very small number of patients and such results may not be observed in a larger patient population, although T4 has demonstrated potential therapeutic benefit, the company's product candidates may not demonstrate safety and/or efficacy in clinical trials, the risk that the company or its collaborators will not obtain approval to market the company's product candidates in the U.S. or abroad, the risks associated with the company's need for additional financing to meet capital requirements necessary for the further development and commercialization activities relating to its product candidates, the risks associated with protecting the company's intellectual property, or that the company will not be able to obtain patent protection, or that its issued patents will be infringed, and such other risks described in the company's quarterly report on Form 10-Q for the period ended September 30, 2008, and other filings it makes with the SEC. Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. The company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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Publication:Business Wire
Date:Jan 21, 2009
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