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J.J. Finkelstein
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Leslie Loyet
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Tim Grace
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RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) announced it is clear to begin its third Phase II clinical trial to test its drug, Thymosin beta 4 (Tß4), for the treatment of patients with epidermolysis bullosa (EB). “We are pleased we are able to proceed according to our clinical development plan,” said David Crockford, Head of Clinical and Regulatory Affairs for RegeneRx. “EB represents a unique opportunity for RegeneRx, both from a scientific and business perspective. The ability of Tß4 to up-regulate the expression of laminin-5, among other things, may be very important for these patients since many are unable to effectively produce this adhesive protein. Further, as an orphan drug, we hope to be able to take advantage of a number of opportunities otherwise unavailable for large-market drugs, including funding of clinical trials by the FDA’s Office of Orphan Products Development.”

The Phase II trial is a randomized, double-blind, placebo-controlled trial designed to test several dosages of Tß4 in a limited number of patients with dystrophic and junctional EB at a number of medical centers in the U.S. The drug will be topically administered to each patient every day over a period of several weeks.

Under the Orphan Drug Act, grants to fund Phase II and Phase III clinical trials for orphan-designated products may be available from the FDA. RegeneRx has previously applied for such a grant and will await word from the agency before formally initiating the study.

Epidermolysis Bullosa
EB is a rare genetic disease characterized by the presence of extremely fragile skin and recurrent blister formation, resulting from minor mechanical friction or trauma. Often these blisters can develop on the skin, eye, mouth, as well as other organs and tissues. There is estimated to be less than 50,000 patients with some form of EB in the U.S. The disorder occurs in every racial and ethnic group throughout the world and affects both sexes equally. Patients with the most severe form of EB either produce defective or little to no laminin-5, a protein that induces both adhesion and migration in a wide variety of cell types, including epithelial cells, fibroblasts, neurons and leukocytes. Laminin-5 plays a key role in maintaining the structural integrity of the skin.

Thymosin Beta 4
Tß4 is a naturally occurring peptide present in virtually all human cells. It represents a new class of wound healing drug and is different from other wound repair factors in that it promotes endothelial cell differentiation keratinocyte migration, and down-regulates a number of inflammatory cells. A key mechanism of action is Tß4's ability to regulate the cell-building protein, actin, a vital component of cell structure. Additionally, it has recently been published that Tß4 directly influences the production of laminin-5, a protein necessary for proper adhesion of certain types of mammalian cells and an important component of the wound healing process. It has also recently been reported that Tß4 can inhibit or prevent apoptosis (programmed cell death) in ocular tissue and, possibly, cardiac tissue. Researchers at the National Institutes of Health (NIH), and at other academic institutions throughout the U.S., have published numerous scientific articles indicating that Tß4 is effective in accelerating dermal and corneal wounds in several animal models, under a variety of conditions. Recently, Tß4 was the subject of a publication in the scientific journal, Nature, indicating its ability to prevent and/or repair cardiac damage in laboratory animals after a myocardial infarction (heart attack).

About RegeneRx Biopharmaceuticals, Inc.
RegeneRx (www.regenerx.com) is a biopharmaceutical company developing Tß4 as a platform technology for the treatment of acute and chronic wounds and for a variety of human diseases involving tissue and organ repair under an exclusive world-wide license from the National Institutes of Health. The company holds over fifty world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, including the treatment and prevention of cardiac and neurological injuries. RegeneRx previously received clearance from the U.S. FDA for its first two Phase II dermal wound healing clinical trials.

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 regulatory approval process and the ongoing and prospective development and commercialization of Tß4 and possible future benefits to the Company, its stockholders, and patients. Due to the nature of clinical trials, product development and the regulatory approval process, the forward-looking statements contained in this press release 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.

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