ROCKVILLE, Md., Feb. 9, 2011 /PRNewswire/ — 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.
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“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.”
About Neuralstem
Neuralstem’s patented technology enables the ability to produce
neural stem cells of the human brain and spinal cord in commercial
quantities, and the ability to control the differentiation of these
cells constitutively into mature, physiologically relevant human
neurons and glia. Neuralstem is in a FDA-approved Phase I safety
clinical trial for Amyotrophic Lateral Sclerosis (ALS), often
referred to as Lou Gehrig’s disease.
In addition to ALS, the company is also targeting major central
nervous system diseases, including
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