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RegeneRx Receives $545,000 Grant From FDA; Funding for Clinical Development of TB4 for Epidermolysis Bullosa

Posted on: Wednesday, 9 August 2006, 09:00 CDT

RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN) today announced that it received a $545,000 grant from the U.S. Food and Drug Administration's (FDA's) Office of Orphan Products Development (OOPD) for the development of its drug candidate based on Thymosin beta 4 (TB4). The two-year grant will be utilized for RegeneRx's Phase II Epidermolysis Bullosa (EB) clinical trial, which is currently enrolling patients.

"We are very pleased to receive this grant from the FDA. Their support provides additional resources to help develop TB4 for patients with EB and elevates the credibility of our effort, which includes the participation of numerous preeminent institutions and physicians around the country. There is no drug currently approved to accelerate wound healing in EB patients and it is our goal to address this need. We appreciate the FDA's diligence in working with us as we move forward with clinical development," commented J.J. Finkelstein, RegeneRx's president and chief executive officer.

David Crockford, principal investigator under the grant and RegeneRx's vice president for clinical and regulatory affairs added, "OOPD has a limited annual budget of approximately $13 million and only funds 12-15 new proposals per year, which makes this grant a highly coveted and recognized accomplishment. It also underscores FDA's recognition of our technology and development plan. Applications receive intensive review, first by OOPD program staff for scientific and technical merit, and then by a panel of independent experts. Another level of review is then conducted by a national advisory council. This is a significant accomplishment for RegeneRx."

Epidermolysis Bullosa

Epidermolysis bullosa is a rare, and often devastating, genetic disease that has been designated an orphan indication by the U.S. FDA. It is estimated that less than 50,000 in the U.S. are affected with some type of EB, with a similar number in Europe. EB is characterized by the presence of extremely fragile skin and recurrent blister formation resulting from minor mechanical friction or trauma often associated with routine daily activity. These blisters develop into chronic, raw wounds that can also occur in the eye, mouth, and internal organs and tissues. In its most severe form EB is painful, debilitating, and requires constant care. 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 produce less laminin-5, a protein that induces both adhesion and migration in a wide variety of cell types. Laminin-5 plays a key role in maintaining the structural integrity of the skin and is a vital protein needed for proper healing of wounds. In addition to accelerating wound healing, TB4 has been shown to increase the production of laminin-5.

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. In an article published in the scientific journal, Nature, researchers found 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.

Orphan Drug Act

The Orphan Drug Act was created in 1983 to encourage commercialization of medical products to treat diseases with a U.S. prevalence of less than 200,000 patients. A company with an orphan drug approved for marketing in the U.S. receives seven years of post-market approval exclusivity, waiver of certain FDA user fees, tax credits of up to 50% of qualified U.S. clinical trial expenses, and eligibility for FDA research grants for 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 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: Business Wire

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