Our Mission

To develop and commercialize novel pharmaceutical products that prevent or repair tissue and organ damage caused by disease, trauma, or other pathology.

Company Background

RegeneRx is a publicly-traded biopharmaceutical company focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Our stock is traded on the American Stock Exchange (AMEX) under the symbol RGN. We are headquartered in Bethesda, Maryland.

RegeneRx utilizes an outsourcing business model in order to effectively control costs while focusing on clinical development of our drug candidates. We use this model for research and development, manufacturing, drug formulation and clinical trials, as well as for other functions critical to our mission. We believe this approach enhances our ability to allocate resources rapidly to different projects without having to invest in infrastructure.

Researchers at the National Institutes of Health (NIH), and other preeminent institutions, have been working with thymosin beta 4 (Tß4) to evaluate its ability to accelerate wound healing and prevent tissue damage. Data generated from their studies have been published in major scientific journals showing that Tß4 has a number of important biological activities that appear to be useful for a broad range of medical indications. Therefore, we are developing Tß4 as a therapeutic platform and clinically evaluating its efficacy in several medical areas.

Previously, we successfully completed a Phase I dermal clinical trial showing that Tß4 was well-tolerated and exhibited no toxicity in humans. We now have three Phase II clinical trials underway at major medical centers in the U.S. and in Europe, one of which is being conducted by our European partner, Sigma-Tau Pharmaceutical Group. Additionally, we were cleared by the U.S. FDA to begin a Phase II IND for an ophthalmic indication during the second quarter of 2007, as well as a Phase I cardiovascular indication, both of which should initiate in the third quarter of 2007.

Product Development

The Company intends to independently develop Tß4 in the U.S. and enter strategic alliances in other markets, as appropriate. RegeneRx will finance and conduct clinical trials at least through the end of Phase II to establish product efficacy. The results of Phase II and the anticipated costs for multi-centered Phase III clinical trials will determine whether we will continue independently or enter strategic alliances for Phase III. In either event, we will likely enter marketing agreements with major pharmaceutical companies for all approved products.

Research and Development

The Company's research and development efforts are primarily focused on collaborating with major research institutions to expand our technology platform, contracting with external organizations for manufacturing and formulation of our products, and the sponsorship of human clinical trials. Typically, we work with academic and government institutions through material transfer agreements (MTAs) or cooperative research and development agreements (CRADAs) that provide us with the ability to license new technology that may emanate from the collaborations. In other cases, we utilize clinical research organizations (CROs) that provide research and development capabilities on a fee for service basis.

Intellectual Property

In February 2001, RegeneRx secured an exclusive world-wide license from the NIH's Office of Technology Transfer to all rights to Tß4 for wound healing. Under an earlier research agreement with The George Washington University, we retain exclusive rights to patents obtained from sponsored research associated with septic shock and associated syndromes including acute respiratory disease syndrome (ARDS). RegeneRx also owns patents for the use of Tß4 (and other related compounds) for stimulation of hair growth, which may result from repair of damaged or non-functional hair follicles. We have filed nearly 60 world-wide patent applications for other compositions, combinations, and clinical indications for our technology platform.