International Research Team Publishes Details of TB4's Cardioprotective Effects in Ischemia-Reperfusion Study
BETHESDA, Md.--(BUSINESS WIRE)--April 24, 2008--REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) announced that in the most recent issue of the medical journal, Circulation, an independent team of medical researchers from Germany and the U.S. published new and expanded data showing that administration of thymosin beta 4 (TB4) significantly decreased heart damage after cardiac ischemia and reperfusion in pigs. In this study, the animals underwent LAD occlusion (blockage of coronary artery) for 60 minutes to simulate a heart attack and were then reperfused (opening of coronary artery) to simulate the standard of care for AMI (heart attack) patients. TB4 or a placebo was then infused directly into the damaged area. TB4 significantly decreased cardiac tissue damage, enhanced function of the damaged heart tissue, and reduced MPO levels (an enzyme associated with inflammation and adverse outcomes in patients with acute coronary syndrome) when compared to placebo.
The authors of the paper concluded that, "Taken together, thymosin beta 4 reveals a pleiotropic pattern (multiple means) of cardioprotection, including activation of cardiomyocyte survival pathways, inhibition of endothelial apoptosis and limitation of inflammatory cell recruitment. The therapeutic potential of early TB4 protein application might be of relevance in the setting of ischemia-reperfusion in patients, since no side effects are known to date limiting its applicability in this scenario."
RegeneRx believes this study is notable for several important reasons: (1) this is the first time the cardioprotective effects of TB4 have been shown in a porcine (pig) model, the closest model to human cardiovascular structure; (2) this is the first study to show TB4's cardioprotective effects in an ischemia-reperfusion model, utilizing a standard of care common to the treatment of human heart attack patients; and (3) this study shows that TB4 is a key protein secreted from circulating stem cells and promotes cardioprotection.
"We are very excited to see this paper published at this time because we have initiated a Phase I clinical trial with RGN-352 (RegeneRx's TB4 formulation for injectable administration) and it provides additional data in a clinically-relevant in vivo model suggesting RGN-352 has the potential to add significant clinical benefit to current standards of care in the emergency room setting for heart attack patients," said J.J. Finkelstein, RegeneRx's president and chief executive officer.
This study confirms and elaborates the results seen in the original work published in Nature by Dr. Deepak Srivastava and his colleagues in 2004, as well as recently published data using TB4 in permanently ligated (permanent coronary artery closure) small animal models. Preliminary data related to this work were first reported at a November 5, 2007 American Heart Association meeting in Orlando, Florida.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel molecules 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 wound healing, respectively. These product candidates are based on TB4, 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 its technology and is currently sponsoring three Phase II chronic dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase IA parenteral clinical trial supporting systemic delivery of RGN-352 for cardiovascular indications.
RegeneRx Technology Backgrounder
TB4 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 TB4 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 TB4'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 TB4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.
Forward-Looking Statements
This 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 the therapeutic potential of TB4 and its relevance to ischemia-reperfusion and the potential clinical benefits for heart attack patients. 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 although TB4 has demonstrated potential therapeutic benefit in pigs, the Company's product candidates may not demonstrate safety and/or efficacy in clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that the company's or its collaborators will not obtain approval to market the company's product candidates, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with reliance on collaborators for the funding or conduct of further development and commercialization activities relating to the company's product candidates, and such other risks described in the company's latest annual report on Form 10-K, and other filings the company 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. The company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: RegeneRx Biopharmaceuticals, Inc.
J.J. Finkelstein, 301-280-1992
jjfnk@regenerx.com
SOURCE: RegeneRx Biopharmaceuticals, Inc.
Posted: April 2008
