Scientists Report Impressive Research Results with Tβ4 on First Day of Thymosin Meeting

REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) (www.regenerx.com) today reported on the results of several important research programs with Thymosin beta 4 (Tβ4) presented at the Second International Symposium on Thymosins in Health and Disease, in Catania, Italy. The following are synopses of the presentations:

Myocardial Effects of Tβ4

Dr. Ildiko Bock-Marquette, University of Texas, Southwestern Medical Center in Dallas, TX and her colleagues, reported that Tβ4 is “the first known molecule initiating simultaneous myocardial and vascular regeneration” in the heart after systemic administration. She went on to explain that, “efforts to use stem cells to repopulate damaged tissue are currently limited by technical consideration and restricted cell potential” and that “Tβ4 could be sufficiently utilized to inhibit myocardial cell death and stimulate vessel growth…”

Dr. Paul R. Riley, UCL Institute of Child Health in London, England, and his colleagues, who had previously reported that Tβ4 was essential for cardiac stem cell development, reported that Tβ4 also induces neovascularization (growth of new blood vessels) and tissue regeneration in the injured adult heart. According to Dr. Riley, “efficient cardiac regeneration post-myocardial infarction (MI) requires the replacement of lost cardiomyocytes, formation of new coronary blood vessels and appropriate modulation of inflammation to prevent maladaptive remodeling, fibrosis/scarring and consequent cardiac dysfunction. In the absence of extrinsic stimuli the adult mammalian heart is unable to mount an efficient reparative response following injury.” They reported that Tβ4 induced neovascularization and stimulated epicardial derived cells (cells from the heart), which facilitated survival and recovery and regenerative replacement of destroyed heart tissue, and “represents a significant step towards therapy for acute myocardial infarction (heart attack) in humans.”

Neurological Effects of Tβ4

Dr. Daniel C. Morris, Henry Ford Health Systems, Detroit, MI, and his colleagues, reported on Tβ4’s effect on functional neurological outcome in a rat model of embolic stroke (lack of oxygen to the brain caused by a blood clot). Using standardized evaluation criteria, the research team found that rats treated with Tβ4, post-stroke, demonstrated statistically significant overall improvement compared to controls. Dr. Morris stated that they observed remyelination (regeneration of the nerve sheath) of the axons and concluded that, “Tβ4 improves neurological functional outcome after embolic stroke in rats,” which is believed to be due to axonal (nerve cell fiber) remodeling.

Dermal Scarring Effects of Tβ4

Dr. Paul Ehrlich, Penn State University School of Medicine, Hershey, PA, presented new data on the effects of Tβ4 on wound healing and scarring in rat models. He found that the Tβ4-treated animal wounds were void of myofibroblasts (cells involved in wound-repair responses) and produced wounds that had regular, uniform, and organized collagen fiber bundles. According to Dr. Ehrlich, “The absence of myofibroblasts reported in other studies also show uniform organized granulation tissue collagen fiber bundles that undergo wound contraction at the same rate and are as strong as or stronger than untreated wounds enriched in myofibroblasts.” The reduction of myofibroblasts and organization of the collagen fibers resulted in scars that were significantly reduced in size and volume.

“Today’s presentations were very exciting as they further elaborated the clinical potential of our technology. There appears to be a new theme emerging having to do with tissue scarring. In several tissue sites, some of which were discussed today, reduction of scar volume (fibrosis), such as in the heart and liver, appear to correlate with better clinical outcome, while reduction in scar volume in the skin appears to allow stronger, better quality scars that could have important implications in aesthetic surgery,” stated J.J. Finkelstein, RegeneRx’s president and chief executive officer. “Dr. Morris’ data on Tβ4’s effect on regenerating neurological tissue after a stroke was similar to the first studies presented on cardioprotection and are impressive. The fact that remyelination was observed has significant implications in neurodegenerative diseases such as multiple sclerosis. We are looking forward to tomorrow’s presentations and will report on those relevant to our programs,” Mr. Finkelstein commented.

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. RegeneRx is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. 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 recently completed a Phase I clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications. 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, collagen deposition, and down-regulates 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 U.S., 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, RGN-352, and RGN-457. Clinical results and/or commercial benefit may differ materially from those described in presentations by researchers at the Thymosin meeting, some of whom collaborate with RegeneRx. 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 June 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.