RegeneRx's Tβ4 Significantly Improves Functional Recovery in Multiple Sclerosis Animal Model

RegeneRx's Tβ4 Significantly Improves Functional Recovery in Multiple Sclerosis Animal Model

BETHESDA, Md.--(BUSINESS WIRE)--REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers at the Henry Ford Health System in Detroit, Michigan, demonstrated for the first time that Tβ4 treatment of EAE (experimental autoimmune encephalomyelitis - an animal model for multiple sclerosis) significantly improves neurological functional recovery. In addition to this neurological benefit, the researchers reported a significant reduction of inflammation and induction of oligodendrogenesis (maturation of central nervous system cells associated with the formation of the nerve sheath), the control of which are important therapeutic goals.

The study entitled, "Neurological Functional Recovery after Thymosin Beta 4 Treatment in Mice with Experimental Auto Encephalomyelitis," was published online ahead of print in Neuroscience, 2009 September 24. The publication highlights the statistically significant effects of Tβ4 treatment in EAE mice, including improvement of neurological functional recovery, reduction of inflammatory infiltrates in the brain, and increase of oligodendrocyte progenitor cells (a type of stem cell) and mature oligodendrocytes in the brain.

The research team was led by Jing Zhang, MD, PhD; Zheng Gang Zhang, MD, PhD; Dan Morris, MD; Yi Li, MD; Cynthia Roberts, Stanton B. Elias, MD, and Michael Chopp, PhD of the Departments of Neurology and Emergency Medicine at the Henry Ford Health System in Detroit, Michigan and the Department of Physics at Oakland University in Rochester, Michigan.

Multiple Sclerosis (MS)

There is no cure for MS. While considerable progress has been made in the recent years with the development of anti-inflammatory and immunomodulatory therapies, there are currently no effective repair therapies routinely used in multiple sclerosis patients. Clinical trials have clearly demonstrated that an anti-inflammation treatment approach alone is insufficient in preventing or ameliorating permanent and accumulating MS deficits. Moreover, many medications have serious side effects and some carry significant risks. Oligodendrogenesis/remyelination is an important therapeutic goal and the subject of the research described in the journal article.

Tβ4 and RGN-352

Tβ4 peptide 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 in the U.S., have published 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:

RGN-352 is an injectable formulation of Tβ4 that has just completed Phase I clinical trials and has been shown to be safe and well-tolerated. The product candidate has been developed to address medical indications where systemic administration is warranted. RegeneRx is currently planning a Phase II clinical trial to evaluate RGN-352 in post-acute myocardial infarction (heart attack) patients, although other indications such as stroke, ischemic renal disease, and certain ulcerative and autoimmune conditions have been identified as potential targets.

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.

Forward-Looking Statements

This press 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 any future development efforts for RGN-352 as a treatment for stroke, multiple sclerosis, or other neurological indications, the results of future trials involving Tβ4, and the therapeutic potential of Tβ4 for neurological indications, or its use in other pharmaceutical or consumer products. 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 RegeneRx's product candidates may not demonstrate safety and/or efficacy in its ongoing or future clinical trials and other development efforts, including its trials and/or other development efforts related to RGN-137, RGN-259, RGN-352 and RGN-457, the risk that RegeneRx or its collaborators will not obtain approval to market RegeneRx's product candidates in the U.S. or abroad, the risks associated with RegeneRx's need for additional financing to meet capital requirements necessary for the further development and commercialization activities relating to RegeneRx's product candidates, the risks associated with protecting RegeneRx's intellectual property, or that RegeneRx will not be able to obtain patent protection, or that its issued patents will be infringed, and such other risks described in RegeneRx's annual report on Form 10-K for the year ended December 31, 2008 and quarterly report on Form 10-Q for the period ended March 31, 2009, and other filings RegeneRx 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. RegeneRx undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.