RegeneRx Biopharmaceuticals, Inc. announced that it has shifted its near-term clinical development focus to RGN-259, its preservative-free topical eye drop, for the treatment of symptomatic dry eye. This reprioritization of the company's product pipeline is primarily due to recently announced data supporting the development of RGN-259 for this indication.

In two studies evaluating RGN-259 to treat symptomatic dry eye induced in mice, RGN-259 resulted in statistically significant improvement of corneal healing compared with negative and positive controls. Previous studies in animal models have also shown the ability of RGN-259 to repair the cornea after chemical damage. Following these animal data, and in conjunction with previously reported human clinical data, RegeneRx is expediting its ophthalmic clinical program and is planning a phase II clinical trial in patients with dry eye that will be designed to measure the safety and efficacy of RGN-259 in this indication. This will be in addition to a physician-sponsored clinical trial in patients with dry eye that is currently being supported by RegeneRx in the form of manufacturing and regulatory and clinical guidance.

The company's decision to refocus its development efforts on dry eye also results from uncertainty caused by the previously announced clinical hold of the company's phase II clinical trial with its RGN-352 product candidate for patients who have experienced an Acute Myocardial Infarction (AMI), commonly known as heart attack. As previously reported, this trial has been placed on clinical hold by the US Food and Drug Administration (FDA) due to current Good Manufacturing Practice (cGMP) compliance issues at one of the Company's contract manufacturers. While RegeneRx seeks to resolve the compliance issues with the FDA and its manufacturer, the Company cannot predict how long the trial will be on clinical hold. If the FDA were to require re-manufacture of either RGN-352 or placebo for the trial, it would significantly delay enrollment and would require RegeneRx to bear substantial additional cost associated with the trial.

“Because of the new positive data that complement our earlier human and animal ophthalmic data, the relatively short timeframe in which we believe we can generate human dry eye data in a phase II trial, and the significantly reduced cost as compared with the phase II AMI trial, we believe it is in the best interest of the company and our stockholders to place our highest priority on the clinical development of RGN-259. We are fortunate to have several drug candidates in development and the ability to quickly reprioritize our clinical focus,” stated J J Finkelstein, RegeneRx's president and chief executive officer.

C Neil Lyons, RegeneRx's chief financial officer, added, “This reprioritization of our development programmes is financially positive. Our cash burn will be substantially reduced and, therefore, so will our future capital requirements. The proposed dry eye trial will be significantly less expensive to conduct compared with the AMI trial due to shorter trial length, fewer and less complex analyses for each patient, and fewer clinical sites.”

The FDA's clinical hold on the phase II AMI trial does not affect RGN-259 or any other RegeneRx clinical trial or drug candidate. The hold is limited to cGMP compliance issues related to RGN-352 at a separate contract manufacturing site and is not directed at the safety of RGN-352, the Company's Phase 2 AMI protocol or its clinical development plan.

According to Global Data, an industry market research firm, the world-wide annual market for dry eye disorders was approximately $1.9 billion in 2010 and is estimated to reach $2.8 billion by 2017. The development of dry eyes can have many causes. They include age - people over age 65 often experience some symptoms of dry eyes; gender - women are more likely to develop dry eyes due to hormonal changes caused by pregnancy, the use of oral contraceptives, and menopause; medications - certain medicines, including antihistamines, decongestants, blood pressure medications and antidepressants; medical conditions - persons with rheumatoid arthritis, diabetes, thyroid problems, Sjögren's syndrome, and lupus are more likely to have symptoms of dry eyes; blepharitis - inflammation of the surfaces of the eye, or the inward or outward turning of eyelids can cause dry eyes to develop; environmental conditions - exposure to smoke, wind and dry climates can increase tear evaporation resulting in dry eye symptoms and other factors - long term use of contact lenses, and refractive eye surgeries, such as LASIK.

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tß4, for tissue and organ protection, repair and regeneration.