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January 3, 2014
08:23 EDTRGRXRegeneRx receives orphan drug designation for Thymosin beta 4
RegeneRx Biopharmaceuticals announced that it has received Orphan Drug designation from U.S. FDA’s Office of Orphan Products Development for its drug candidate, Thymosin beta 4, or Tβ4, for the treatment of Neurotrophic Keratopathy, a serious degenerative disease of the corneal epithelium. A reduction in corneal sensitivity or complete corneal anesthesia is the hallmark of this disease and is responsible for producing corneal ulceration, perforation, pain and impaired vision. The designation, for novel drugs to treat diseases with a prevalence of less than 200,000 patients in the U.S., provides seven years of extended marketing exclusivity, waiver of FDA user fees, tax credits of up to 50% of qualified clinical trial expenses, and eligibility of FDA research grants for clinical trials. "In a previous physician-sponsored clinical study with RGN-259, the drug candidate stimulated healing within 4-8 weeks in patients with NK who had non-healing corneas for a minimum of six weeks to over a year. Our clinical experience to date also indicates that RGN-259 is safe, well-tolerated, and significantly improves patient comfort,” explained J.J. Finkelstein, RegeneRx’s president & CEO.
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July 15, 2014
09:06 EDTRGRXRegeneRx announces publication of Thymosin beta4 data
RegeneRx announced that a new paper entitled, Thymosin beta4 Prevents Cardiac Rupture and Improves Cardiac Function in Mice with Myocardial Infarction, was published in the journal, Heart Circulation Physiology, on July 11. The company said, “The present study shows for the first time that Tbeta4 is able to reduce incidence of cardiac rupture post-MI and markedly improved cardiac function at 5 weeks after MI, and that the cardiac protective effects of Tbeta4 after MI were associated with a significant reduction of excessive inflammatory response and cardiomyocyte apoptosis as well as with an enhancement of angiogenesis. From a clinical point of view, Tbeta4 could potentially be a therapeutic candidate for patients with acute MI." Animals were treated with Tbeta4 daily at a relatively low dose for 7 days using a minipump implant. Treatment with Tbeta4 ameliorated left ventricular dilation, improved cardiac function, and not only decreased the mortality rate due to cardiac rupture but also significantly improved cardiac function after MI. The study received funding from the Henry Ford Health System and the National Institutes of Health. RegeneRx provided the Tbeta4 under a Material Transfer Agreement.

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