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Researchers Report that Tβ4 Increases Skeletal Muscle and May Have a Role in the Treatment of Duchenne Muscular Dystrophy

Researchers Report that Tβ4 Increases Skeletal Muscle and May Have a Role in the Treatment of Duchenne Muscular Dystrophy

February 5, 2010 — Bethesda, Md

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that a research team in Washington, D.C. has found that dystrophin-deficient Mdx mice, treated twice a week for six months with Tβ4, showed a significant increase in skeletal muscle regenerating fibers compared to untreated mice. No effects related to muscle function or fibrosis and no adverse reactions were observed in the mice. Mdx mice are used as models for Duchenne muscular dystrophy to evaluate potential therapeutic compounds. According to the research team, "In exercised dystrophin deficient mice, chronic administration of Tβ4 increased the number of regenerating fibers in skeletal muscle and could have a potential role in the treatment of skeletal muscle disease in Duchenne muscular dystrophy." Because Tβ4 stimulates cell migration and anti-apoptosis pathways in skeletal muscle cultures, these data further suggest a role for Tβ4 in muscle degenerative diseases and injury.

"This study is particularly important as it provides the first direct correlation of gene expression data with in vivo administration and histological localization of Tβ4 in muscle tissue," stated Dr. Allan L. Goldstein, Professor of Biochemistry and Molecular Biology at the George Washington University Medical Center, Washington, DC, and RegeneRx's chief scientific advisor.

The research team was led by Dr. Christopher Spurney, Division of Cardiology, Children's National Medical Center, Washington, DC. The paper was published in PLoS One (a National Institutes of Health, peer-reviewed online journal), 2010 Jan 29; 5:1-5.

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 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. It is currently in phase II clinical development for dermal and ophthalmic wound healing and has now completed a Phase I clinical trial supporting delivery of RGN-352 for acute cardiovascular and other indications requiring systemic administration. RegeneRx is also developing novel peptides for the cosmeceutical industry based on its experience with Tβ4 and its biological activities in the skin.

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, and collagen deposition, while down-regulating 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 world, 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. Abstracts of scientific papers related to Tβ4'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, including in diseases such as Duchenne muscular dystrophy. Further, 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, 2008 and such other items described in the filed Company's quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2009 or 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.

SOURCE
RegeneRx Biopharmaceuticals, Inc.

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