Thymosin beta 4 to be Studied for the Treatment of Degenerative Muscle Diseases and Cardiomyopathy
Aug 5, 2005 - 6:48:00 PM
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"This is a very exciting study as it may relate to previously published work showing TB4's ability to protect/repair the heart after an acute myocardial infarction. We look forward to testing it in our models to see if we can produce similar results," said Dr. Spurney. "If TB4 is shown to be protective, we would hope to move into human clinical trials."
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By RegeneRx Biopharmaceuticals, Inc.,
[RxPG] RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN) (www.regenerx.com) reported today that it has begun a collaboration with doctors at Children's National Medical Center (CNMC), Division of Cardiology, in Washington, D.C., to study the effects of thymosin beta 4 (TB4) to treat degenerative muscle diseases that often result in cardiomyopathy -- the progressive deterioration and weakness of the heart.
Cardiomyopathy can lead to arrhythmias, heart failure, and sudden death. For most patients with cardiomyopathy, transplantation of a new heart is the only viable treatment. In the U.S. there are over 84,000 patients with degenerative muscular dystrophy diseases and about 50,000 patients with cardiomyopathy.
The project is being directed by Dr. Christopher Spurney, Assistant Professor of Pediatrics at CNMC, and will study the effects of TB4 in non-human models that have a disease similar to human Duchenne muscular dystrophy and go on to develop cardiomyopathy.
"This is a very exciting study as it may relate to previously published work showing TB4's ability to protect/repair the heart after an acute myocardial infarction. We look forward to testing it in our models to see if we can produce similar results," said Dr. Spurney. "If TB4 is shown to be protective, we would hope to move into human clinical trials."
According to Dr. Allan Goldstein, Chairman of Biochemistry and Molecular Biology at the George Washington University Medical School, Washington, D.C. and Chief Scientific Advisor to RegeneRx, "Dr. Spurney's team at Children's is among the most experienced in the world in degenerative muscle diseases and their effects on the heart. We are pleased to work with such an esteemed group to determine what TB4's role may be for this important medical area."
Thymosin Beta 4
TB4 is a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes endothelial cell differentiation, keratinocyte migration, collagen deposition, and down-regulates certain inflammatory cells. A key mechanism of action is TB4's ability to regulate the cell-building protein, actin, a vital component of cell structure. Additionally, TB4 directly influences the production of laminin-5, a protein responsible for proper adhesion and migration of certain types of mammalian cells and an important component of the wound healing process. 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 (NIH), 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 appeared in the scientific journal, Nature, indicating that TB4 prevents and/or repairs cardiac damage in laboratory animals after a myocardial infarction (heart attack).
Publication:
Children's National Medical Center (CNMC), Division of Cardiology, Washington, D.C.
On the web:
www.regenerx.com 
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Additional information about the news article
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RegeneRx Biopharmaceuticals, Inc.
RegeneRx (www.regenerx.com) is a biopharmaceutical company developing TB4 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, as well as issued patents related to the treatment of septic shock. RegeneRx recently received clearance from the U.S. FDA for its first three Phase II dermal wound healing clinical trials and has targeted cardiac and ophthalmic wound healing as part of its ongoing clinical development program.
Children's National Medical Center
Children's National Medical Center (CNMC) is listed as one of America's best pediatric institutions by U.S. News & World Report, having provided care to children and their families throughout the Washington, D.C. metropolitan area for more than 130 years. It is the major academic pediatric medical center in the region, and has close affiliations with The George Washington University and Georgetown University. CNMC has a very active research community pursuing both basic science research, community health research, translational research, and clinical trials. In 2004, CNMC had 281 funded research projects and a grant portfolio of $44.8 million, more than 64% of which came from federal agencies.
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 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.
Contact RegeneRx Biopharmaceuticals, Inc. J.J. Finkelstein, 301-280-1992 [email protected] or At the Financial Relations Board: Media Inquiries Tim Grace, 312-640-6667 or Analyst Inquiries Leslie Loyet, 312-640-6672 or General Inquiries Kathy Waller, 312-640-6696
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