REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) announced today that its ophthalmic drug candidate, RGN-259, was used to treat four neurotrophic keratitis patients with non-healing eye ulcers caused primarily by the herpes zoster virus under a "Compassionate Use" IND (Investigational New Drug application). RGN-259 is a sterile eye drop formulation of Tβ4 being developed by RegeneRx for use in treating ophthalmic wounds and related disorders.

Dr. Steven Dunn, a corneal specialist and the sponsor/principal investigator of the IND, utilized RGN-259 to treat the corneal ulcers that had not healed for at least six weeks and in some cases several months, despite all standard treatments. In all four patients, the eye ulcers either completely healed or demonstrated significant improvement by treatment day 28, the maximum treatment period allowed under the clinical protocol. The patients were followed for an additional 30 days post-treatment. The results showed that completely healed ulcers remained healed and those that had demonstrated significant improvement continued to improve after treatment by RGN-259 was stopped. RGN-259 was well-tolerated and there were no drug-related adverse events.

The clinical investigators under the IND include Dr. Dunn, Dr. David Heidemann and Dr. Christopher Chow, of Michigan Corneal Consultants, P.C., Southfield, Michigan; and Dr. Gabriel Sosne, Associate Professor of Ophthalmology at Wayne State University School of Medicine and Kresge Eye Institute in Detroit, Michigan, and a member of RegeneRx's Medical and Scientific Advisory Board. They intend to publish their results after completion of treatment of six total patients.

"We are encouraged by the striking response we have seen so far in this difficult-to-manage group of patients. Neurotrophic keratitis is a serious, frequently debilitating, eye problem. These are patients whose corneal ulcers would not heal despite treatment with standard medical therapies. Corneal infection, perforation, scarring and impaired vision or blindness are the all too often sequellae in this condition," commented Dr. Dunn. "In addition to improved healing, the treated eyes appeared much 'quieter' (less inflammation) and patients reported that their eyes felt much better. If necessary, we will extend the treatment regimen for the next two patients to see if we can achieve complete healing in cases where it may take longer than 28 days." "Time after time I have seen Tβ4's positive effects in reducing inflammation and accelerating wound healing in experimental animal models. It is exciting to now see such dramatic clinical improvement in patients whose corneal ulcers would not heal despite the best available medical care," commented Dr. Sosne.

Neurotrophic Keratopathy

Neurotrophic keratopathy is a degenerative eye disease characterized by decreased corneal sensitivity and poor corneal healing. The most common causes are viral infection (herpes simplex and herpes zoster keratoconjunctivitis) followed by chemical burns, physical injuries, and corneal surgery. This disease leaves the cornea susceptible to injury and epithelial breakdown that can lead to ulceration, infection, stromal melting, and perforation secondary to poor healing. The management of this condition is one of the most difficult and challenging among all corneal diseases. Of the 40,000 - 60,000 cases of herpes zoster ophthalmicus occurring each year, 50% will have ocular involvement, 16% will demonstrate some form of neurotrophic keratopathy and 15% will develop serious complications.

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. The Company is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on Tβ4, 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, a Phase II ophthalmic wound healing clinical trial, and a Phase I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications.

RegeneRx Technology Background

Tβ4 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 Tβ4 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 Tβ4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to Tβ4'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 Tβ4's mechanisms of action may be viewed at RegeneRx's web page: http://www.regenerx.com.

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 safety and efficacy of RGN-259, the company's ability to capitalize on the compassionate use treatment of RGN-259 described in this release, the company's ability to enter into any collaborations with respect to the development or commercialization of its product candidates, and the therapeutic potential of Tβ4 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 Tβ4 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 the company's 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 the company 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.