RegeneRx


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J.J. Finkelstein
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Researchers Find New Evidence of RegeneRx's TB4 Wound Healing Activities in the Eye; Data to be Reported at 2006 ARVO Meeting

Researchers Find New Evidence of RegeneRx's TB4 Wound Healing Activities in the Eye; Data to be Reported at 2006 ARVO Meeting

March 1, 2006 — Bethesda, Md

RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN) reported today that Thymosin beta 4 (TB4) will be the subject of three presentations at the 2006 Association for Research in Vision and Ophthalmology (ARVO) meeting in Ft. Lauderdale, Florida next month. The abstracts of these studies are available at www.arvo.org.

In the first reported study, researchers found that TB4 stimulates the production of MMP-1, an enzyme produced by human cornea epithelial cells that plays a key role in wound healing by promoting rapid epithelial cell migration, resulting in accelerated repair of injured tissues. The study was headed by P. Qiu, et. al., in the Department of Ophthalmology and Anatomy/Cell Biology at Wayne State University School of Medicine in Detroit.

In the second reported study, researchers found that TB4 exerts its anti-inflammatory properties by down-regulating NF-KBp65 and decreasing IL-8 expression. NF-KBp65 is an important signaling molecule that regulates gene activation. IL-8 is a protein expressed by injured and stressed cells that triggers the migration of white blood cells to the site of an injury, resulting in local inflammation and possible damage to the eye. These findings are consistent with previously reported data indicating that TB4 can down-regulate the inflammatory response when administered locally to the cornea. The study was headed by G. Sosne, et. al., at the Wayne State University and collaborators in the Department of Biomedical Sciences, University of Detroit Mercy School of Dentistry.

In a third study, Taiwanese researchers reported that "TB4 is essential for its anti-apoptotic effect (prevention of programmed cell death) on human cornea epithelial cells" exposed to toxic levels of hydrogen peroxide. This conclusion confirms previous studies by Sosne, et. al., showing the anti-apoptotic effect of TB4 in the eye and those of D. Srivastava, et. al., showing TB4's anti-apoptotic effects in protecting cardiac tissue following a heart attack. The research was conducted by H. C.J. Ho, et. al., Department of Ophthalmology, Buddhist Tzu Chi Gen Hospital, Taipei, Taiwan Republic of China.

"These studies are very important as they add to the significant body of evidence indicating TB4's affect on ophthalmic wound healing. Knowing the biological mechanisms by which TB4 works will continue to help us identify the various clinical indications best suited for this molecule and its derivatives," stated Dr. Gabriel Sosne, assistant professor of ophthalmology at the Wayne State University Medical School in Detroit, Michigan.

"As more work is done with TB4 we are finding additional important evidence of the relationship between TB4 and wound healing. In addition to the work presented at ARVO, Dr. Sosne reported last October that diabetic patients have a lower than normal amount of TB4 in their corneas compared to non-diabetics, and the National Institutes of Health previously reported that TB4 accelerated wound healing in diabetic animals. Diabetics typically have diminished wound healing capabilities. We also know that there is less TB4 in human tears as we age. Therefore, it seems quite plausible that the diminishment of TB4, due to aging or disease, may be overcome by administering TB4 to patients to repair injured or damaged tissue," stated J.J. Finkelstein, RegeneRx's president and CEO.

Thymosin Beta 4
TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. One of TB4's key mechanisms of action is its ability to regulate the cell-building protein, actin, a vital component of cell structure and movement. Additionally, TB4 directly influences the production of laminin-5, a protein responsible for proper adhesion and migration of certain types of mammalian cells and often deficient in patients with EB. It has also recently been reported that TB4 can inhibit or prevent apoptosis (programmed cell death) in ocular tissue and cardiac tissue. Researchers at the National Institutes of Health, and at other academic institutions throughout the U.S., have published numerous scientific articles indicating that TB4 is effective in accelerating dermal and corneal wound healing in several animal models, under a variety of conditions. A recent article was published in the scientific journal, Nature, indicating that TB4 protects heart tissue following a myocardial infarction (heart attack) in laboratory animals. Abstracts of scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.

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 TB4, a 43 amino acid peptide, under an exclusive world-wide license from the National Institutes of Health. Preliminary research suggests that TB4 may prove efficacious for multiple indications; therefore RegeneRx is developing TB4 as a therapeutic platform. RegeneRx holds over fifty world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, cardiac and neurological injuries, and septic shock. RegeneRx is currently sponsoring three Phase II chronic dermal wound healing clinical trials and has additionally targeted ophthalmic and cardiac trials in 2006 as part of its ongoing clinical development program.

Safe Harbor Statement
The information in this press release may include certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements concern the Company's current expectations regarding future events, including the ongoing and prospective development of TB4 and possible future benefits to the Company, its shareholders, and patients. Due to the nature of product development and the regulatory approval process, the forward-looking statements are subject to risks and uncertainties, including those reflected in the Company's filings with the Securities and Exchange Commission, particularly its most recent Annual Report on Form 10-KSB. The Company assumes no obligation to update or revise any forward-looking statements made herein or any other forward-looking statements made by the Company.

For more information please visit RegeneRx's web site at www.regenerx.com

SOURCE: RegeneRx Biopharmaceuticals, Inc.

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