FDA News

NeuroHealing Pharmaceuticals Receives Grant from the FDA Office of Orphan Drugs for Clinical Development of NH001

(July 17, 2008)-- NeuroHealing Pharmaceuticals, a company developing products for individuals with chronic brain injuries, announced that the Food and Drug Administration (FDA) has awarded the company a three-year grant of $1,044,000 to assist in the clinical development of NH001. NH001 is under clinical development to improve the functional outcome of patients in a vegetative state or minimally conscious state following a severe traumatic brain injury. The product has demonstrated promising results in an open label Phase IIa trial and has received authorization from the FDA to begin a double blind Phase II clinical trial, under an open IND. NH001 received Orphan Drug Status from the FDA in 2006.

"This is a significant milestone and accomplishment for NeuroHealing," commented Elkan Gamzu, PhD, acting Head of Clinical Trials at NeuroHealing. "We are very pleased to receive this support from the FDA as it represents a nice validation of the promise of NH001. This grant will provide the initial funding to begin the clinical program at the Spaulding Rehabilitation Hospital, a Harvard Medical School affiliated hospital and one of the leading rehabilitation facilities in the U.S., and will enable the continued development of this treatment which may offer patients, their families and physicians a new therapeutic option to help brain injured patients in an altered consciousness state."

Dr. Ross Zafonte, Earle P & Ida S Charlton Chair of the Department of Physical Medicine & Rehabilitation at Harvard Medical School, and Vice President of Medical Affairs for Spaulding Rehabilitation Hospital, Boston will be the principal investigator of this FDA funded study. For more information, visit www.NeuroHealing.com

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