Contact:

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

At the Financial
Relations Board:
Analyst Inquiries:
Leslie Loyet
312.640.6672

or
General Inquiries
Kathy Waller
312.640.6696

or
Media Inquiries
Tim Grace
312.640.6741

RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) announced a second Phase II clinical trial to test its drug, Thymosin beta 4 (Tß4), for the treatment of venous stasis ulcers.

"I'm pleased to report we are clear to initiate our second Phase II dermal wound healing clinical trial with Tß4. This study, which will be conducted by our European pharmaceutical partner, Sigma-Tau Group, will expand our platform to a second dermal wound healing indication - venous stasis ulcers. The study will be conducted in Europe under our U.S. IND, and the clinical data may be used for both the European and U.S. regulatory approval processes," said J.J. Finkelstein, RegeneRx President & Chief Executive Officer.

The Phase II trial will be a randomized, double-blind, placebo-controlled trial designed to test several dosages of Tß4 in patients with venous stasis ulcers in Italy and at least one other European country. The drug will be topically administered to each patient over a period of several weeks. The study is scheduled for the second quarter of 2005 and should be completed and analyzed within approximately one year from enrollment of the first patient.

This trial is the second in a portfolio of complementary clinical trials planned by RegeneRx, designed to evaluate Tß4's effect on wound healing for specific types of dermal and ocular wounds. "We also have plans to study patients with epidermolysis bullosa (EB), a rare skin disorder for which Tß4 has been designated an Orphan Drug, as well as patients with diabetic lower extremity ulcers," said Finkelstein.

Venous stasis ulcers, also called stasis leg ulcers, are shallow wounds that develop when the leg veins do not move blood back toward the heart normally, typically due to sluggish circulation related to age, immobility and/or underlying disease. Such ulcers most often develop on either side of the lower leg, above the ankle and below the calf. Less frequently, blocked veins are a contributing factor in the development of venous leg ulcers. Published data, showing that Tß4 promotes angiogenesis (capillary growth), stimulates cell migration and increases collagen deposition in treated wounds in laboratory animals, provides the rationale for testing the drug in this patient population. It is estimated that nearly 2.5 million people have venous stasis ulcers in the U.S. and a smaller number in Europe.

Thymosin Beta 4
Tß4 is a naturally occurring peptide present in virtually all human cells. It represents a new class of wound healing drug that promotes endothelial cell differentiation and keratinocyte cell migration, angiogenesis in and around wounds, and down-regulates a number of inflammatory cytokines and chemokines. A key mechanism of action is Tß4's ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton. Additionally, it has recently been reported 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 and cardiac tissues. 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, corneal, and myocardial wounds in several animal models, under a variety of conditions.

About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is a biopharmaceutical company developing Tß4 as a platform technology for the treatment of acute and chronic wounds and for the treatment of a variety of human diseases involving tissue and organ repair under an exclusive world-wide license from the National Institutes of Health. The technology is also the subject of over forty-five world-wide patents and patent applications held by RegeneRx related to dermal, ocular, and internal wounds and tissue repair, including the treatment and prevention of cardiac injury. RegeneRx recently received clearance from the U.S. FDA to conduct the first in a series of Phase II dermal wound healing clinical trials with Tß4.

About SIGMA-TAU GROUP, S.P.A.
Sigma-Tau is a leading research-based Italian pharmaceutical company with annual revenues of approximately $1 billion (750 million euros) and over 2400 employees worldwide. Therapeutic areas in which the company's research and development are focused include oncology, neurology, cardiovascular, gastroenterology, metabolism and immunology. Currently, Sigma-Tau is involved in over 40 projects, evaluating 17 molecules and 25 clinical indications. Sigma-Tau has operating subsidiaries throughout Europe and the U.S. and maintains a presence in all of the world's major pharmaceutical markets.

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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