Neuralstem, Inc. (NYSE Amex: CUR) announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted it orphan drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS) with its human spinal cord derived neural stem cells (NSI-566RSC), currently in a Phase I safety study to evaluate the safety of the product and the surgical route of administration in a wide range of ALS patients.
"Congress passed the Orphan Drug Act because it recognized that adequate drugs for many rare diseases have not been developed," said Richard Garr, president and CEO of Neuralstem. "The designation of our spinal cord stem cells as an orphan drug underscores the importance of developing effective treatments for patients with ALS. In addition to providing a seven-year term of market exclusivity for our stem cells for ALS upon FDA approval, Orphan Drug Designation also positions Neuralstem to take advantage of certain financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the submission of a Biologics License Application for NSI-566RSC, and certain tax credits. It is an important step forward for the company."
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