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Researchers Report Thymosin B4 Promotes Spinal Cord Nerve Cell Survival and Neurite Outgrowth

BETHESDA, Md.--(BUSINESS WIRE)--May 15, 2008 - REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) ( reported today that researchers at The Institute of Neuroscience, The Fourth Military Medical University in Xi'an, Shaanxi, PRC found that TB4 significantly enhanced survival of neurons (nerve cells that send electrical signals throughout the body and control muscle movement) and promoted the process of growing neurites, which are tree-like outgrowths of nerve cells that transmit electrical signals. Administering TB4 in vitro had a promotional effect by creating longer and more vigorous outgrowth of the neurites compared to the non-TB4 groups. According to the paper, TB4 exerts its effects on neuron survival and neurites in a dose-dependent manner.

The researchers concluded, "The results may be, in part, due to TB4 regulation of L1 expression. As is well-known, L1 is (an important cell adhesion protein) effective in improving neurite outgrowth and fasciculation (involuntary contracting or twitching of muscle fibers), neuron survival and migration, neuron adhesion as well as synaptic plasticity, and considered to be a potential molecule for nerve regeneration and neurodegenerative diseases." The paper entitled, "The Promotive Effects of Thymosin B4 on Neuronal Survival and Neurite Outgrowth by Upregulating L1 Expression," Yang, et al., was published in the journal, Neurochem Research, May 7, 2008.

"These new data are quite exciting as they appear to confirm similar TB4 activities in other organ systems reported by separate research groups, in particular its ability to increase survival and performance of cardiac cells and corneal epithelial cells. Based on this and previous central nervous system studies with TB4, the use of this peptide, as indicated by the authors of the paper, could expand into potential treatments for neurodegenerative diseases, spinal cord injuries, and possibly nerve regeneration, all of which have very significant unmet medical needs," explained Allan L. Goldstein, Ph.D., Professor and Chairman of Biochemistry and Molecular Biology, the George Washington University School of Medicine, and Chief Scientific Advisor to RegeneRx.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the discovery and development of novel molecules 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 wound healing, 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 its technology and is currently sponsoring three Phase II chronic dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase IA parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for cardiovascular indications.

RegeneRx Technology Backgrounder

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. Abstracts of scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page:

Forward-Looking Statements

This 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 therapeutic potential of TB4. 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 although TB4 has demonstrated potential therapeutic benefit for wound healing and cardioprotection, the Company's product candidates may not demonstrate safety and/or efficacy in clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that the company's or its collaborators will not obtain approval to market the company's product candidates, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with reliance on collaborators for the funding or conduct of further development and commercialization activities relating to the Company's product candidates, and such other risks described in the company's annual report on Form 10-K, 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.


RegeneRx Biopharmaceuticals, Inc.
J.J. Finkelstein, 301-280-1992

Posted: May 2008