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RegeneRx:
J.J. Finkelstein
jjfnk@regenerx.com
301.280.1992

RegeneRx Biopharmaceuticals, Inc. (NYSE Alternext:RGN) reported today that researchers at the University of Texas Southwestern Medical Center (UTSW) in Dallas, Texas, published a new paper elaborating on the regenerative effects of Tβ4 on heart cells and blood vessel growth after a heart attack in a rodent model. According to UTSW, “The new findings in mice suggest that introducing Tβ4 systemically after a heart attack encourages new growth and repair of heart cells. The research findings indicate that the molecule affects developmental gene expression as early as 24 hours after systemic injection.” The researchers also state that, “Tβ4 is the first known molecule capable of organ-wide activation of embryonic coronary developmental program in the adult mammalian heart after systemic administration...”

“This molecule has the potential to reprogram cells in the body to get them to do what you want them to do. Obviously, the clinical implications of this are enormous because of the potential to reverse damage inflicted on heart cells after a heart attack,” commented Dr. J. Michael DiMaio , the senior author of the study and a cardiothoracic surgeon at UTSW.

The study was published April 10 , online in the Journal of Molecular and Cellular Cardiology and will appear in the journal in May. The work was supported by the American Heart Association , the National Institutes of Health , and the Ted Nash Long Life Foundation . Dr. Deepak Srivastava , one of the authors of the study, is a member of RegeneRx's Scientific Advisory Board .

“We are pleased and impressed with the work conducted at UTSW, which expands upon the original work done in Dr. Srivastava's lab when he was at UTSW and published in the journal Nature. The fact that they found that Tβ4 caused new blood vessel growth and prevented the death of heart cells after injury is further confirmation of the previously reported biological activities of Tβ4 and its potential as a drug to treat patients with ischemic injuries to the heart,” stated Dr. Allan L. Goldstein , discoverer of Tβ4, professor of biochemistry at The George Washington University Medical School and chief scientific advisor to RegeneRx. “Their discovery of molecular signals triggered by Tβ4 that are essential for the differentiation of stem cells and repair of heart tissue following a heart attack strongly support RegeneRx's clinical efforts in human subjects focused on cardioprotection and repair of the heart after ischemic damage.”

About RegeneRx Biopharmaceuticals, Inc.
Earlier this year RGN reported that it has successfully completed a Phase I clinical trial in 80 healthy human subjects with RGN-352, a parenteral (injectable) formulation of Tβ4, with the specific goal of moving forward with a Phase II trial in patients after a heart attack. The Company is engaged in preliminary discussions with several pharmaceutical companies developing new therapies to prevent and repair acute heart damage. 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.

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 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 www.regenerx.com .

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 the ability of Tβ4 to encourage new growth and repair of heart cells after a heart attack, the potential of Tβ4 as drug to treat patients with ischemic injuries, including the heart and other organs, any future development efforts for Tβ4 or RGN-352 as a treatment for cardiac indications such as heart attack, the results of future trials involving Tβ4, and the therapeutic potential of Tβ4 for dermal, ophthalmic and cardiovascular wounds or pulmonary 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 quarterly report on Form 10-Q for the period ended September 30, 2008, 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.

SOURCE: RegeneRx Biopharmaceuticals, Inc.

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