RegeneRx Files IND to Begin Phase 2 Ophthalmic Clinical Trial
- Category: Proteins and Peptides
- Published on Saturday, 31 March 2007 03:00
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BETHESDA, MD, USA | Mar 30, 2007 | REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) (www.regenerx.com) announced that it has filed an Investigational New Drug Applications (IND) with the U.S. FDA requesting permission to begin a Phase 2 clinical trial to evaluate the safety and wound healing efficacy of a Thymosin beta 4 (TB4) eye drop formulation in patients recovering from ophthalmic surgery. The company may initiate the study 30 days after filing the IND if it does not otherwise hear from the agency.
The Phase 2 ophthalmic trial will enroll diabetic patients undergoing vitrectomy surgery who have a small flap removed from their corneas during surgery. Diabetic patients often have difficulty healing properly. RegeneRx's focus will be to determine whether a TB4-based eye drop is as effective in treating corneal wounds in humans as it has been shown to be in various animal models by Dr. Gabriel Sosne and his colleagues at the Kresge Eye Institute in Detroit, as well as others. Dr. Sosne's work has shown that TB4 can reduce inflammation, prevent apoptosis (natural cell death), improve cellular adhesion (connection between various cell layers), and promote re-epithelialization (re-growth of the outer layer of the cornea), all of which are vital to the complex wound healing process. Dr. Sosne is a member of the company's medical and scientific advisory board.
"We have been diligently working toward this goal over the past year and look forward to the initiation of the first human clinical trials with TB4 in ophthalmic patients. Formulating a sterile ophthalmic eye drop required extensive process research, conducted on a very tight time line. I would like to thank all our collaborators and RegeneRx staff for working so hard to ensure we met our filing target for this IND application," said David Crockford, RegeneRx's vice president for clinical and regulatory affairs.
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, in part, 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 the cornerstone of its therapeutic platform. The technology platform has many potential applications in both the pharmaceutical and consumer products sectors. RegeneRx holds nearly 60 world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, cardiac and neurological injuries, septic shock and several consumer product areas. RegeneRx is currently sponsoring three Phase 2 chronic dermal wound healing clinical trials and has additionally targeted ophthalmic and cardiac trials in 2007 as part of its ongoing clinical development program.
The RegeneRx Technology Platform
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. Of the thousands of proteins in cells, actin represents up to 10% of the total protein and, thus, plays a major role in the physiology of the cell. RegeneRx has identified several molecular variations of TB4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. 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 two articles published in the scientific journal, Nature, researchers found that TB4 protects heart tissue following a myocardial infarction (heart attack) and can regenerate coronary vessels 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.
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-K. 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: RegeneRx Biopharmaceuticals, Inc.