RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for its application claiming methods for treating, preventing, inhibiting or reducing tissue deterioration due to congestive heart failure disease using Thymosin beta 4 (Tβ4), its isoforms and fragments, and important analogs.
The patent is projected to expire July 2027.
“We are very pleased to be receiving this important patent using Tβ4 to treat congestive heart failure,” said J.J. Finkelstein, chief executive officer of RegeneRx. “We have a number of other patent applications in this field in the U.S. and around the world where we are awaiting similar action. This new patent will be an important part of our intellectual property estate that we will continue to expand for treatment of the heart and surrounding tissues.”
RegeneRx also announced that it has received a patent in Mexico for treating or preventing biological or immunological response to reactive chemical, biological, or toxic agents using Tβ4.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tβ4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development and has an extensive worldwide patent portfolio covering its product candidates.
RGN-352 is an injectable formulation of Tβ4 to treat cardiovascular and central nervous system diseases, as well as other medical indications. 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 over a wide dose range. The Company previously planned to initiate a Phase 2 clinical trial at approximately 20 clinical sites in the U.S., Israel, and Russia; however, this trial is currently on an FDA-imposed clinical hold due to cGMP issues at an outside contract manufacturer. Last year, RegeneRx 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. RegeneRx has recently completed two animal studies showing RGN-259’s positive effects on dry eye symptoms and has positive human data indicating its ability to heal corneal ulcers. Based on these data, the Company is sponsoring a double-masked, placebo-controlled Phase 2 clinical trial. Of seven previous patients with non-healing ocular surface defects who were treated with RGN-259, all had complete or substantial healing. Three additional patients with punctate epithelial defects of the cornea reported reduction in eye inflammation and increased comfort following treatment with RGN-259. RegeneRx is also supporting a small physician-sponsored Phase 2 dry eye study with RGN-259.
RGN-137, a topical gel formulation of Tβ4, 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.
source:RegeneRx Biopharmaceuticals, Inc.