RegeneRx Biopharmaceuticals, Inc. announced that the company received a patent from the Mexico Patent and Trademark Office for the use of Thymosin Beta 4 (TB4), its analogues, isoforms, and other derivatives, for preventing or healing the damage that occurs from a myocardial event, or heart attack. The patent expires in 2022. RegeneRx has similar patents pending in a number of countries, including the US. Based on recent clinical data, this year the company filed additional worldwide patent applications, which, if granted, could potentially extend patent protection in this area until 2030.

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or TB4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three products in clinical development.

RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack. Recent pre-clinical efficacy data suggests that RGN-352 may also benefit patients with multiple sclerosis, stroke and traumatic brain injury. RegeneRx has successfully completed a Phase 1 clinical trial with RGN-352 in which the drug candidate was found to be safe and well-tolerated.

The company has initiated a Phase 2 clinical trial and expects to enroll the first patient by early 2011 at approximately 25 clinical sites in the US, Israel, and Russia. RegeneRx is also supporting a phase 1/2 physician-sponsored clinical trial in patients with multiple sclerosis that is expected to begin in 2011. RegeneRx recently received a $3 million, three-year development grant from the NIH to support the company's acute myocardial infarction program.

RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on recent human clinical data, RegeneRx is currently supporting a physician-sponsored Phase 2 dry eye study with RGN-259. Previously, seven patients with non-healing corneal ulcers were treated with RGN-259 under compassionate use INDs. Five had complete healing and two had substantial healing of their wounds. Three additional patients with corneal defects, called punctate keratitis, had no evidence of healing although they did report reduction in eye inflammation and increased comfort.

RGN-137, a topical gel formulation, is currently being evaluated by RegeneRx in a Phase 2 clinical trial for the treatment of the orphan skin disease epidermolysis bullosa. Other potential uses for RGN-137 include the treatment of chronic dermal wounds and reduction of scar tissue. RegeneRx previously received $675,000 in grants from the US FDA to support this clinical trial.

In addition to the pharmaceutical product candidates described above, RegeneRx is pursuing the commercial development of peptide fragments of TB4 for potential cosmeceutical use. RegeneRx holds numerous patents and patent applications worldwide related to its products and holds an exclusive worldwide license from the National Institutes of Health, as well as other licenses related to TB4. The company recently received $733,438 in funding under the Patient Protection and Affordable Care Act to support each of its product candidates.