First Human Data on RegeneRx's Drug Candidate RGN-259 Published in Archives of Ophthalmology

Complete Corneal Wound Healing Observed in Patients with Chronic Eye Ulcers

ROCKVILLE, Md.--(BUSINESS WIRE)--May 14, 2010 - RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today the publication of the first human data from a case study of patients evaluated with its ophthalmic product candidate RGN-259. The data have been published in the May 2010 issue of Archives of Ophthalmology, an American Medical Association peer-reviewed journal. In the study, four patients with chronic neurotrophic keratitis, a degenerative corneal disease induced by a nerve impairment, were treated with RGN-259 under a compassionate use IND. The most common causes of this disease include the herpes zoster virus.

To be eligible for treatment in the study, patients must have had a corneal lesion that had remained unhealed for a minimum of six weeks. In one case, a patient had a non-healing wound for nearly 14 months. The patients were treated for 28 days with RGN-259 and evaluated 28 days after treatment. Three of the patients experienced complete healing of their wounds, with substantial healing in the fourth patient. There were no drug-related adverse events and all patients reported reduced ocular irritation.

The study was conducted by Dr. Stephen Dunn and his colleagues in the Department of Ophthalmology, Children's Hospital of Michigan, Wayne State University, and the William Beaumont Hospital in Detroit, Michigan. Dr. Dunn is not affiliated with the Company; Dr. Gabriel Sosne, a co-author of the study, is a member of RegeneRx's scientific advisory board.

Dr. Dunn and his colleagues are planning a Phase 2 study with RGN-259 in patients with dry eye associated with graft vs. host disease later this year that will be supported, in part, by RegeneRx.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tβ4, for tissue and organ protection, repair and regeneration. Currently, RegeneRx has formulated three product candidates in clinical development: RGN-352, an injectable formulation for systemic delivery to treat cardiovascular diseases, central nervous system diseases, and other medical indications that require administration by injection, that has completed a Phase 1 clinical trial; RGN-259, a sterile, preservative-free topical eye drop for ophthalmic indications that is currently being supported in compassionate use studies; and RGN-137, a topically applied gel for chronic dermal wounds and reduction of scar tissue that is currently in a Phase 2 clinical trial for the treatment of epidermolysis bullosa. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack, although recent animal research suggests that this formulation may also benefit patients with multiple sclerosis and stroke. RegeneRx has a fourth product candidate, RGN-457, which is an inhaled formulation targeting cystic fibrosis and other pulmonary diseases, in pre-clinical development. These product candidates are based on Tβ4, a synthetic copy of a 43-amino acid, naturally-occurring peptide that is the subject of an exclusive worldwide license from the National Institutes of Health. In addition to the four pharmaceutical product candidates described above, RegeneRx is pursuing the commercial development of peptide fragments of Tβ4 for potential cosmeceutical use. RegeneRx holds over 60 worldwide patents and patent applications related to its product candidates.

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. 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. These forward-looking statements include statements regarding the proposed clinical development of RGN-259. You are urged to consider statements that include the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” ”may,” “potential” or the negative of those words or other similar expressions words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risks and uncertainties inherent in our business, including, without limitation the risk that our product candidates do not demonstrate safety and/or efficacy in future clinical trials; risks related to our ability to obtain financing to support our operations on commercially reasonable terms; the progress, timing or success of our clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing our product candidates; regulatory developments; the size and growth potential of the markets for our product candidates and our ability to serve those markets; the scope and validity of patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and other risks described in the Company's filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” sections of the annual report on Form 10-K for the year ended December 31, 2009, filed with the SEC on March 31, 2009, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

 

Contact: RegeneRx
Lori Smith, 301-208-9191

 

Posted: May 2010

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