Contact Information: At RegeneRx: At the Financial |
RegeneRx Holds 2004 Annual Stockholders' Meeting RegeneRx Holds 2004 Annual Stockholders' Meeting June 24, 2004 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX; www.regenerx.com) held its 2004 annual stockholders' meeting June 23rd in Washington, D.C., electing six directors for the 2004 fiscal year, including one new director. Joining the RegeneRx Board of Directors is Mauro Bove, head of corporate development and a member of the Board of Directors of Sigma-Tau Finanziaria S.p.A., the Sigma-Tau Group ("Sigma-Tau") holding company and RegeneRx's largest shareholder and strategic partner in Europe. "We are very pleased to welcome Mauro to our Board. His broad expertise in financing, deal-making, and licensing - all key components of pharmaceutical product development - will be of great value to us as we expand our efforts in the coming months," said J.J. Finkelstein, RegeneRx's President and CEO. The stockholders also voted to expand the Company's Stock Option and Incentive Plan from 2.5 to 3.2 million shares, and they elected Reznick Fedder & Silverman, P.C., as independent auditors. During the meeting Dr. Allan Goldstein, RegeneRx's Chairman and Chief Scientific Advisor, presented the latest research findings related to Thymosin beta 4 (Tß4), the cornerstone of the Company's wound healing technology platform. He explained how Tß4 accelerated wound healing in various animal models and discussed how its mechanism of action could be applicable across a broad spectrum of clinical indications, including tissue repair in the eye as well as internal disorders. Goldstein also briefly discussed the Company's clinical trials and other areas of clinical interest. Finkelstein reviewed the past year's operating results, RegeneRx's Phase II clinical trial strategy (including Sigma-Tau's decision to accelerate Phase II trials in Europe), the impact of Orphan Drug designation, and the various financings the Company completed over the past twelve months with a look toward the next twelve months. He also explained RegeneRx's outsourcing strategy and its impact on the Company's operations. Tß4 is a naturally occurring 43-amino acid peptide present in virtually all human 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 cell differentiation and keratinocyte cell migration, down-regulates a number of inflammatory cytokines and chemokines, and has a relatively low molecular weight, allowing it to diffuse relatively long distances through tissues. Key mechanisms of action are Tß4's ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton as well as induce the production of laminin-5 and promote tissue re-epithelialization. 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 experimental conditions. RegeneRx is a biopharmaceutical company 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. Recently, RegeneRx received Orphan Drug designation for Tß4 for the treatment of epidermolysis bullosa. Phase I clinical trials were successfully completed with Tß4 for the treatment of dermal wounds and Phase II trials are expected to begin shortly. Sigma-Tau is a leading research-based Italian pharmaceutical Group with annual revenues in excess of $700 million and over 2300 employees worldwide. Therapeutic areas in which the company's research and development are focused include oncology, neurology, cardiovascular, gastroenterology, metabolism and immunology. Sigma-Tau has operating subsidiaries throughout Europe and the U.S. and maintains a presence in all of the world's major pharmaceutical markets. Sigma-Tau's press releases and corporate information are available at www.sigma-tau.it and www.sigmatau.com. 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. |
