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Researchers Report Novel Biological Properties of Fragments of Thymosin Beta 4

BETHESDA, Md.--(BUSINESS WIRE)--Feb 26, 2010 - RegeneRx Biopharmaceuticals Inc.REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that a university research team has published an article ahead of print in FASEB Journal, a high-impact scientific journal, describing novel biological properties of several Thymosin beta 4 (Tβ4) peptide fragments. The researchers summarize related published studies and report on their work showing that Tβ4 and these smaller peptides were able to block inflammation, reduce fibrosis, promote cell survival and block apoptosis, stimulate stem/progenitor cell differentiation, induce angiogenesis, and promote cell migration. Other activities include the induction of various genes encoded for important proteins involved in cell development (such as laminin-5, MMPs, TGF beta, zyxin, terminal deoxynucleotidyl transferase, and angiogenesis-related proteins) and activate signaling pathways that influence cell and tissue survival (such as ILK/PINCH/Akt). The paper also describes the potential clinical use of these small peptides.

“These novel studies with Tβ4 fragments speak to the importance of understanding how wound healing, repair, tissue regeneration, and the inflammatory process may be regulated by different regions of the intact Tβ4 molecule. This is important because the results may provide specific functional targets for future therapeutic applications using different parts of the Tβ4 molecule and identify new opportunities, not only for ongoing clinical applications, but also for novel cosmeceutical applications as well,” stated Dr. Gabriel Sosne, the lead investigator.

“Dr. Sosne’s data are very exciting as they help us better understand what biological role certain fragments of this multi-faceted molecule play. Testing and understanding their activities may also allow us to achieve therapeutic benefits with smaller molecules, at potentially lower cost. Additionally, we believe we can utilize several of these smaller peptide fragments in new and advanced cosmeceutical products. This has been our strategy for some time and, thus, we have filed patent applications on these peptide fragments throughout the world,” commented J.J. Finkelstein, RegeneRx’s president and chief executive officer. The research team was led by Dr. Gabriel Sosne, Associate Professor of Ophthalmology at Wayne State University School of Medicine, Department of Ophthalmology and Anatomy/Cell Biology in Detroit, Michigan. Dr. Sosne is a member of RegeneRx’s scientific advisory board. The EPub is available online FASEB J. 2010 Feb 23. [Epub ahead of print] and will soon be followed in the printed journal.

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 2 clinical development for dermal and ophthalmic wound healing and has now completed a Phase 1 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:

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, RGN-352 and Tβ4 fragments. Further, the research described herein may not prove to be beneficial or may not result in any commercial or profitable products. One should consider 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.


J.J. Finkelstein



Posted: February 2010