NIH Awards Over $5,000,000 for Tβ4 Research in 2009/2010

Grants Awarded to Numerous RegeneRx Collaborators

BETHESDA, Md.--()--REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that National Institutes of Health (NIH) has awarded 12 research grants totaling over $5,000,000 for the study of Tβ4 in 2009/2010. Many of these grants will be going to collaborators with whom RegeneRx is working to understand its numerous biological activities and capabilities in medical indications, including the role of Tβ4 as an anti-inflammatory agent in tissue regeneration and its promotion of stem cell maturation. Research on the identification and characterization of the key factors needed to trigger stem cell differentiation and maturation are among the most active areas of medical research and are believed to be fundamental to the future development of breakthrough therapeutic agents. Additional research projects are focused on understanding the mechanisms of action and role of Tβ4 in diverse areas of biomedicine ranging from cardiovascular disease and kidney fibrosis to neurological disorders and memory. The research funded by these grants will advance our understanding of the basic mechanisms of Tβ4’s actions and its clinical potential.

“NIH grants are peer-reviewed with fewer than 20% of applicants receiving this prestigious funding. These awards demonstrate the high value that the scientific community and NIH place on both thymosin β4 technology and the research teams exploring its potential,” stated Dr. Hynda K. Kleinman, a scientist at the NIH for 31 years, who has served on numerous grant review panels, and currently a consultant for RegeneRx and a member of its scientific advisory board.

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 sponsoring Phase II clinical trials 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 its 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. The NIH grants to study Tβ4 described in this press release may not prove to be of value to the Company or could show negative results in certain cases. 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.

Contacts

RegeneRx Biopharmaceuticals, Inc.
J.J. Finkelstein, 301-280-1992
jjfnk@regenerx.com

Contacts

RegeneRx Biopharmaceuticals, Inc.
J.J. Finkelstein, 301-280-1992
jjfnk@regenerx.com