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Research Publication Shows TB4 Protects Human Gingival Cells From Damage

Posted on: Tuesday, 9 September 2008, 09:00 CDT

REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) (www.regenerx.com) announced today that researchers have shown that TB4 provides multi-functional protection to human gingival (gum) cells similar to its previously published activities in the eye and heart. TB4 significantly suppressed the secretion of inflammatory cells to protect gingival cells against several known toxic agents while also preventing apoptosis (cell death).

"Because of its multifunctional role in protecting cells against damage TB4 may have significant potential for use as an oral healthcare aid due to its combined anti-microbial, anti-inflammatory, anti-apoptotic, and cyto-protective properties," commented Gabriel Sosne, M.D., Associate Professor of Ophthalmology at Wayne State University School of Medicine and the Kresge Eye Institute in Detroit, MI, and a member of RegeneRx's Medical and Scientific Advisory Board.

The research was published in the European Journal of Oral Sciences 2008: 116: 424-430. Dr. Sosne led the research team from the Department of Ophthalmology, Kresge Eye Institute, Detroit, MI; Department of Anatomy and Cell Biology, Wayne State University School of Medicine, Detroit; and Department of Biomedical Sciences, University of Detroit Mercy School of Dentistry.

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. These product candidates are based on TB4, 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 to reduce cardiac damage in patients after acute myocardial infarction, in addition to other systemic indications.

RegeneRx Technology Background

TB4 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 TB4 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 TB4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to TB4's cardio-protective effects have been published in Nature and Circulation. Abstracts of these and other scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.

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 may be identified by the words "project,""believe,""anticipate,""plan,""expect,""estimate,""intend,""should,""would,""could,""will,""may" or other similar expressions and include statements regarding the safety and efficacy of RGN-137, RGN-259 and RGN-352 and the status and prospects of any ongoing research studies and clinical trials. Actual results may differ materially from those indicated or implied by such forward-looking statements because the Company's product candidates may not demonstrate safety and/or efficacy in current or future clinical trials or as a result of various important factors 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, 2007 filed with the SEC on March 28, 2008 and other periodic reports filed 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.


Source: Business Wire

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