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RegeneRx Files With FDA for Second Phase II Clinical Trial; European Trial to Study TB4 In Patients With Venous Stasis Ulcers

Posted on: Monday, 20 December 2004, 09:00 CST

RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) announced that it has filed with the FDA to initiate a Phase II clinical trial to test its drug, Thymosin beta 4 (TB4), for the treatment of venous stasis ulcers.

"This will be our second Phase II trial evaluating the safety and efficacy of TB4 in patients with chronic dermal wounds," explains J.J. Finkelstein, RegeneRx President & Chief Executive Officer. "The trial will be conducted in Europe by our partner, Sigma-Tau Group. Sigma-Tau has agreed to pay for the trial and RegeneRx will supply the drug product. The study will be conducted under our U.S. IND so that the resulting data may be utilized for regulatory approval in both the United States and Europe," he went on to say.

The Phase II trial is a randomized, double-blind, placebo-controlled trial designed to test several dosages of TB4 in patients with venous stasis ulcers. The drug will be topically administered to each patient over a period of several months and should be completed and analyzed within eighteen months from initiation.

The trial is the second in a portfolio of five complementary clinical trials planned by RegeneRx for 2005-2006, designed to evaluate TB4's effect on wound healing for specific types of dermal wounds including in patients with epidermolysis bullosa (EB), a rare skin disorder in children and young adults for which TB4 has been designated an Orphan Drug, and patients with diabetic lower extremity ulcers. As part of its Phase II program, RegeneRx is also planning on initiating its first wound healing clinical trial in the ophthalmic field (relating to the eye) during this period.

RegeneRx successfully completed a Phase I clinical trial in healthy volunteers in 2003 and reported that there were no drug-related toxicities associated with use of TB4 and that it was well-tolerated by the study participants. The Company recently initiated a Phase II study in patients with chronic pressure ulcers.

Venous stasis ulcers result from an insufficiency of blood flow, typically to lower extremities, that is caused by a combination of factors including age, immobility and underlying disease, such as diabetes. Published data showing that TB4 promotes angiogenesis in and around wounds, and accelerates healing 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

TB4 represents a new class of wound healing drug and has been the subject of a substantial amount of research at the National Institutes of Health (NIH), and other research institutions, where it has been reported to be effective in the repair of dermal and corneal wounds under a variety of conditions.

Recently, in an article published in the November 25th issue of Nature, researchers showed that administration of TB4 significantly reduced the amount of tissue damage in the hearts of mice that were subjected to induced myocardial infarctions, or heart attacks, compared to a placebo - the first time TB4 has been shown to repair or prevent damage in a whole organ. The researchers also showed that the animals receiving TB4 had significantly higher cardiac function following the heart attack.

TB4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. It promotes endothelial cell differentiation and keratinocyte cell migration, down-regulates a number of inflammatory cytokines and chemokines, and induces collagen deposition. A key mechanism of action is TB4's ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton. Additionally, TB4 directly promotes angiogenesis in and around wounds and 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.

REGENERX BIOPHARMACEUTICALS, INC.

RegeneRx is a biopharmaceutical company developing TB4 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 NIH. The Company holds several patents related to the technology and has over forty-five world-wide patent applications pending. The company successfully completed a Phase I human clinical trial with TB4 that demonstrated its safety for use in the treatment of chronic dermal wounds and has initiated a Phase II trial in patients with chronic pressure ulcers. Recently, TB4 was designated an "Orphan Drug" by the FDA for the treatment of patients with epidermolysis bullosa, thus potentially extending the period of market exclusivity and allowing the company to be eligible for FDA grants and tax credits, among other benefits.

SIGMA-TAU GROUP

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 and is RegeneRx's largest shareholder. Therapeutic areas in which the company's research and development are focused include oncology, neurology, cardiovascular disease, gastroenterology, metabolism and immunology. Sigma-Tau has operating subsidiaries throughout Europe and the U.S. and maintains a presence in all of the world's major pharmaceutical markets.

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 TB4 and possible future benefits to the Company, its shareholders, 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.

Source: Business Wire

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