RegeneRx Receives Orphan Drug Designation for Tβ4 in the Treatment of Neurotrophic Keratopathy
January 03, 2014 08:22 AM Eastern Standard Time
ROCKVILLE, Md.--(BUSINESS WIRE)--RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("the Company" or "RegeneRx") announced that it has received Orphan Drug designation from U.S. FDA's Office of Orphan Products Development (OOPD) for its drug candidate, Thymosin beta 4 (Tβ4), for the treatment of Neurotrophic Keratopathy (NK), a serious degenerative disease of the corneal epithelium (the outside layer of the eye). 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.
"Orphan designation offers us a number of opportunities that would not otherwise have been available. It is an important milestone -- the result of the significant and growing body of data supporting Tβ4's development for this serious disorder, often caused by the herpes zoster virus and diabetes mellitus. In a previous physician-sponsored clinical study with RGN-259 (our preservative-free, sterile, ophthalmic eye drop whose active ingredient is Tβ4), 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.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic (RGN-259), cardiac (RGN-352) and dermal (RGN-137) indications, two strategic licensing agreements in China and the EU, and has an extensive worldwide patent portfolio covering its products. The Company also has developed several peptides that it believes may be useful improving aging skin in the cosmeceutical field.
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2012, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
Lori Smith, 301-208-9191