NIH Scientists Accelerate Hair Growth with Tß4

RegeneRx's Tß4 Effects Critical Events In Hair Follicle Cycle

RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX, http://www.regenerx.com/) announced that its lead therapy, Thymosin Beta 4 (Tß4), which promotes tissue growth and wound repair, can also stimulate hair growth in laboratory animals.

According to a National Institutes of Health (NIH) study, "Tß4 exerts a profound hair-promoting effect through a combined action on several critical events in hair follicle growth."

The findings are published in the December 2003 online issue of the journal of the Federation of American Societies for Experimental Biology.

According to Dr. Allan Goldstein, Chairman of Biochemistry and Molecular Biology at The George Washington University School of Medicine and Chief Scientific Advisor to RegeneRx, "The most important features of the NIH studies are:

Corroborating data on the mechanism of action of Tß4 (including: angiogenesis, cell migration, cell differentiation and remodeling of the extra-cellular matrix); and

Evidence that Tß4, which accelerates tissue regeneration by regulating actin, accelerates hair growth in existing hair follicles by promoting the migration of stem cells to the base of the follicles, among other key events."

"The formulation and method of administration of Tß4 in the NIH studies were significantly different than those used for wound healing," emphasized Goldstein. "To that end, Tß4, or Tß4 combined with other hair growth agents, may provide a new therapeutic approach for treating alopecia and other skin disorders associated with hair loss."

"This is very exciting, although not entirely unexpected," added J.J. Finkelstein, RegeneRx President and CEO. "We in-licensed the rights to Tß4 two years ago for promoting hair growth, so the newly published scientific data confirm our expectations. Meanwhile, we are evaluating a whole new set of business opportunities available to us and quite apart from our current focus on developing Tß4 for the wound-healing market."

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

Previously, it has been reported by NIH that Tß4 was effective in accelerating the healing of dermal wounds in normal, aged, diabetic and steroid-suppressed laboratory animals as well as ocular wounds in several animal models.

RegeneRx Biopharmaceuticals, Inc. is developing Tß4 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 patent applications pending. The Company also holds a separate, exclusive world-wide license related to Tß4 and its use for hair regeneration and treatment of alopecia (loss of hair).

The Company has successfully completed Phase I human clinical trials with Tß4 for the treatment of chronic dermal wounds and expects to begin Phase II trials in the first half of 2004.

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 Tß4 and possible future benefits to the Company, its shareholders, 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.