Contact Information:

At RegeneRx:
J.J. Finkelstein
jjfnk@regenerx.com
301.280.1992

At the Financial
Relations Board:
Tim Grace
Media Inquiries
312.640.6741

Leslie Loyet
Analyst Inquiries
312.640.6672

Kathy Waller
General Inquiries
312.640.6696

RegeneRx Biopharmaceuticals, Inc. (OTCBB: RGRX) (www.regenerx.com), announced today that it has successfully completed a Phase 1 clinical trial with its lead therapy, Thymosin beta 4 (Tß4), a novel wound-healing drug. Fifteen volunteers were subjects of the six month study that was initiated in March 2003 and designed to evaluate four different dosage regimens.

“The Phase 1 safety study was completed on time and as expected,” said RegeneRx President and CEO J.J. Finkelstein. “We are very pleased with the results. Tß4 was well tolerated, there were no adverse side-effects related to the drug, and all laboratory data were in accordance with our expectations.”

Tß4 is a naturally occurring 43-amino acid peptide that is vital for the repair and remodeling of injured tissues. It exhibits anti-inflammatory properties, is nontoxic, active systemically and topically, and can be produced synthetically at low cost. Unlike other prospective wound treatments, it is not a growth factor.

“We plan to maintain this momentum as we move into Phase 2 trials,” continued Finkelstein. “To that end, we are preparing a final report for the FDA as we continue our preparations for the next series of clinical trials, which will evaluate the safety and efficacy of Tß4 in patients with different types of chronic dermal wounds.”

About RegeneRx
RegeneRx is a biopharmaceutical company focusing on the development of products to treat chronic wounds and a variety of human diseases involving tissue and organ repair. The Company is developing Tß4 under an exclusive worldwide license from the National Institute of Health (NIH). RegeneRx also holds several patents related to the technology and has numerous worldwide patent applications pending.

About Tß4
Tß4 is present in virtually all human cells. Its gene is up-regulated following tissue injury and during the remodeling and differentiation of cells and is found in highest concentrations in blood platelets, the first cells to enter wounds. Unlike other wound repair treatments, such as growth factors, Tß4 promotes endothelial and keratinocyte cell migration, down-regulates a number of inflammatory cytokines and chemokines, promotes angiogenesis, and has a very low molecular weight that allows it to diffuse relatively long distances through tissues. It also has the unique ability to regulate the cell-building protein actin -- a vital cytoskeletal component. The NIH and other academic institutions have reported Tß4 to be effective in the repair of dermal and corneal wounds in numerous animal models under a variety of conditions.

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 and commercialization 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 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.

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