RegeneRx Biopharmaceuticals, Inc., a biopharmaceutical company, focuses on the development of a novel therapeutic peptide, Thymosin beta 4 (Tß4), for tissue and organ protection, repair, and regeneration. Product Candidates RGN-259 RGN-259 is a proprietary preservative-free eye drop formulation of Thymosin beta 4. In September 2011, the company completed a Phase 2a exploratory clinical trial evaluating the safety and efficacy of RGN-259 in 72 patients with dry eye syndrome. Various signs and symptoms of dry eye, such as the degree of ocular surface damage, ocular itching, burning and grittiness were graded periodically during and following the treatment period. Lee’s Pharmaceutical (HK) Limited: As of March 27, 2012, the company had signed a term sheet with Lee’s Pharmaceutical (HK) Limited, headquartered in Hong Kong, for the license of Thymosin Beta 4 in any pharmaceutical form, including its RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong and Macau. RGN-352 RGN-352 is an injectable formulation to treat cardiovascular diseases, central and peripheral nervous system diseases, and other medical indications. During 2009, the company completed a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of the intravenous administration of RGN-352 in 60 healthy subjects. Based on the results of this Phase 1 trial and extensive preclinical efficacy data published in peer-reviewed journals. RGN-137 RGN-137 is a topical gel for dermal wounds and reduction of scar tissue. RGN-137 is being applied topically to the skin, once daily for up to 56 consecutive days. EB has been designated as an ‘orphan’ indication by the FDA’s Office of Orphan Drugs. RGN-457 The company’s preclinical product candidate RGN-457 is based on Tß4 formulated as a liquid aerosol for inhalation therapy. It has completed a substantial amount of preclinical work necessary for an investigational new drug, or IND, application, and the company is in the process of seeking a strategic partner to assist in the development of RGN-457 for the treatment of cystic fibrosis (CF). The anti-inflammatory, mucoactive and antimicrobial properties of Tb4 provide the scientific rationale for use of the RGN-457 in this indication. Strategy The company seeks to maximize the value of its product candidates by advancing their clinical development and then identifying suitable partners for further development, regulatory approval, and marketing. It intends to engage in strategic partnerships with companies with clinical development and commercialization strengths in desired pharmaceutical therapeutic fields. The company is actively seeking partners with suitable infrastructure, expertise and a long-term initiative in its medical fields of interest. The company has entered into a strategic partnership with Defiante Farmaceutica S.A., a subsidiary and one of several entities affiliated with Sigma-Tau Group (Sigma-Tau), a international pharmaceutical company which collectively comprise its largest shareholder, or Sigma-Tau, for development and marketing of RGN-137 and RGN-352 for specified indications in Europe and other contiguous countries. Sigma-Tau also funded and co-managed its Phase 2 clinical trial of RGN-137 in Europe for the treatment of venous stasis ulcers. Intellectual Property The company holds worldwide patents and patent applications covering peptide compositions, uses and formulations related to dermal and ophthalmic indications and other organ and tissue repair activities, as well as for cosmetic and consumer product applications. The company holds a U.S. patent relating to the use of Tß4 for treatment of alopecia, an autoimmune skin disease that results in hair loss, which expires in 2017, with corresponding patents in Europe and Singapore that expire in 2018. In 2006, the company was issued a patent in China for the use of Tß4 to treat EB, which expires in 2022. The company holds a U.S. patent relating to the use of Tß4 for the treatment of congestive heart failure. This patent issued in January 2012, and would expire in 2032. History RegeneRx Biopharmaceuticals, Inc. was founded in 1982. The company was incorporated in Delaware in 1982 under the name Alpha 1 Biomedicals, Inc. In 2000, it changed its name to RegeneRx Biopharmaceuticals, Inc.