RegeneRx


Contact:

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

or

At the Financial
Relations Board:

Analyst Inquiries:
Leslie Loyet
312.640.6672

or
General Inquiries
Kathy Waller
312.640.6696

Researchers Find RegeneRx's TB4 Prevents Cell Death Caused by Common Eye Drop Preservative; TB4 Prevents BAK-mediated Apoptosis in Human Corneal and Conjunctival Epithelial Cells

Researchers Find RegeneRx's TB4 Prevents Cell Death Caused by Common Eye Drop Preservative; TB4 Prevents BAK-mediated Apoptosis in Human Corneal and Conjunctival Epithelial Cells

April 25, 2006 — Bethesda, Md

RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN) reported today that researchers at the Wayne State University School of Medicine and the Kresge Eye Institute in Detroit, Michigan, found that thymosin beta 4 (TB4) could significantly reduce the death of human ophthalmic cells (apoptosis) treated with benzalkonium chloride (BAK), in vitro. BAK is a common preservative contained in many ocular solutions, such as eye drops, to prevent bacterial growth and is a known eye irritant.

In one group within the study, human corneal and conjunctival epithelial cells were treated with escalating doses of BAK, which inhibited DNA synthesis and increased apoptosis throughout the duration of the 5-day test. In another group, similar cells were treated with BAK and TB4. In this group, apoptosis caused by BAK was significantly reduced when measured at various times during the 5-day test. An abstract of the study was published in the April 19, 2006 edition of the scientific journal, Experimental Eye Research and will be followed by the full paper later in 2006.

According to Dr. Gabriel Sosne, Assistant Professor of Ophthalmology and Anatomy/Cell Biology at the Kresge Eye Institute, part of the Wayne State University School of Medicine, and head of the research team, "This study suggests that TB4 may be able to overcome the apoptotic side effect of BAK, and may be a useful additive to solutions containing this preservative. In particular, glaucoma patients who are on chronic medications to lower intraocular pressure commonly use eye drops containing BAK which can cause a high degree of discomfort."

RegeneRx is planning to file an Investigational New Drug (IND) application with the FDA for a proposed ophthalmic clinical trial in the coming weeks.

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.

> Back To 2006 Press Release Archives