RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) reported that researchers at the George Washington University Medical Center in Washington, DC have found that Thymosin beta 4 (Tß4), a molecule currently undergoing clinical trials for wound healing, is present in human tears and appears to decrease with age. This is the first reported study of Tß4 levels in human tears and was presented today at the annual Association for Research in Vision and Ophthalmology (ARVO) meeting in Ft. Lauderdale.

The observation that age may diminish the body's ability to produce Tß4 in tears points to the possibility that Tß4 could be used as a novel therapeutic agent for disorders of the eye, especially in ocular indications that become more frequent with age. This observation would also correlate with previously published studies from the National Institutes of Health (NIH) reporting that Tß4 accelerated dermal wound healing in diabetic, steroid-suppressed, and aged laboratory animal models.

"The presence of Tß4 [or lack thereof] in tears raises the possibility of its role in human ocular surface disease and modulation," according to Dr. Barrett Katz, the lead investigator of the study and the Chairman of Ophthalmology at the George Washington University School of Medicine in Washington, DC and an advisor to RegeneRx. "Studies have demonstrated Tß4 to be a potent agent facilitating corneal wound healing following trauma. Given that Tß4 is a potent anti-inflammatory agent and promotes re-epithelialization, the ocular effects of Tß4 are likely of practical clinical significance."

In addition to Dr. Katz's presentation, there were three other scientific studies with Tß4 reported at the ARVO meeting. These were conducted by Dr. Gabriel Sosne and his colleagues at the Kresge Eye Institute and at the Wayne State University School of Medicine in Detroit, MI. Dr. Sosne reported that: (i) Tß4 increases corneal epithelial cell laminin-5 production (a substance necessary for proper cell adhesion); (ii) Tß4 inhibits the transcription of many key pro-inflammatory cytokines, thus, reducing inflammation in cells covering the cornea after injury; and (iii) Tß4 accelerates the healing of mouse corneas following wounding and significantly down-regulates both inflammation and interior hemorrhaging after injury. These research results continue to augment the growing body of data indicating the potential role of Tß4 in the treatment of both ocular and dermal wounds.

Tß4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. Its gene is up-regulated following tissue injury and during the remodeling and differentiation of cells. Tß4 represents a new class of wound healing drug and is different from other wound repair factors, such as growth factors, in that it promotes endothelial and keratinocyte cell migration, down-regulates a number of inflammatory cytokines and chemokines, and has a very low molecular weight, allowing it to diffuse relatively long distances through tissues. A key mechanism of action is Tß4's ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton. It has been the subject of a significant amount of research at the NIH and a number of other academic institutions, and has been reported to be effective in the repair of dermal and corneal wounds in numerous animal models under a variety of conditions.

RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com) is developing Tß4 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 numerous world-wide patent applications pending. RegeneRx recently began phase I human clinical trials to determine the safety and efficacy of Tß4 for the treatment of chronic dermal wounds.

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 Tß4 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.

Back To 2003 Press Release Archives