RegeneRx Cleared to Initiate First Ophthalmic Phase 2 Clinical Trial in Diabetics Undergoing Eye Surgery
- Category: Proteins and Peptides
- Published on Tuesday, 01 May 2007 04:00
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BETHESDA, MD, USA | Apr 30, 2007 | REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) (www.regenerx.com) announced today that it has been cleared by the FDA to begin its first phase 2 clinical trial to test its drug candidate, Thymosin beta 4 (Tβ4), for the treatment of diabetic patients undergoing vitrectomy surgery. This will be RegeneRx’s first phase 2 clinical trial outside of the dermal wound healing field and an expansion of its technology platform.
The phase 2 trial is a randomized, double-blind, placebo-controlled study designed to test several dosages of Tβ4 in 48 diabetic patients at ophthalmic surgical centers and hospitals throughout the U.S. The sterile eye drop will be topically administered four times per day for up to fourteen days. RegeneRx will use a contract research organization to manage the trial. The expected completion date of the phase 2 study has not been determined but will be reported as soon as possible.
“We are very pleased we are able to proceed according to our clinical development plan,” said David Crockford, vice president for clinical and regulatory affairs. “Diabetic vitrectomy represents a unique opportunity for RegeneRx as the indication is a procedure where diabetic patients often have difficulty with healing after eye surgery. Administration of Tβ4 will give us an opportunity to rapidly assess its safety and efficacy in this group of patients and allow further development for other ophthalmic wounds if successful.”
The decision to pursue ophthalmic wound healing is based on the large body of data generated by Dr. Gabriel Sosne and his colleagues at Wayne State University and Kresge Eye Institute in Detroit, Michigan, showing Tβ4’s anti-inflammatory properties, anti-apoptotic effects (prevention of natural cell death), and acceleration of ophthalmic wound healing in laboratory animals. This data has been published in numerous peer-reviewed medical journals over the past five years and presented at key medical conferences. Dr. Sosne is a member of RegeneRx’s medical and scientific advisory board.
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 Tβ4, a 43 amino acid peptide, in part, under an exclusive world-wide license from the National Institutes of Health. Preliminary research suggests that Tβ4 may prove efficacious for multiple indications; therefore, RegeneRx is developing Tβ4 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, has been cleared to initiate a phase 2 ophthalmic wound healing trial, and has filed an Investigational New Drug application (IND) to initiate a phase 1 clinical trial as part of its ongoing cardiovascular clinical development program.
The RegeneRx Technology Platform
Tβ4 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 Tβ4'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 Tβ4 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 Tβ4 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 Tβ4 protects heart tissue following a myocardial infarction (heart attack) and can regenerate coronary vessels in laboratory animals. Abstracts of scientific papers related to Tβ4'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 Tβ4 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.
SOURCE: REGENERX BIOPHARMACEUTICALS, INC.