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Ceregene Phase 2 Clinical Trial for Alzheimer's Disease to be Funded by $5.4 Million Grant From National Institutes of Health
Date:11/4/2008

ent of CERE-110 was led by Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer and is a continuation of the pioneering work of Mark Tuszynski, M.D., Ph.D., Ceregene's co-founder and a professor of Neurosciences at UCSD," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "Similar to the other therapies in our pipeline which target Parkinson's disease, ocular disorders and ALS (Lou Gehrig's disease), CERE-110 may have the ability to not only treat the symptoms of Alzheimer's disease but to protect dying neurons and potentially result in the slowing of disease progression."

About CERE-110

CERE-110 is composed of an adeno-associated viral (AAV) vector carrying the gene for NGF, a naturally occurring protein that maintains survival of nerve cells in the brain. CERE-110 is surgically injected into the Nucleus Basalis of Meynert (NBM), a brain region where cholinergic cell degeneration occurs in Alzheimer's disease. The cholinergic system is important in memory and cognitive function, and a restoration in the function of this system may improve memory in individuals with Alzheimer's disease. Delivery of NGF using an AAV vector should have the potential to induce sustained expression of NGF, resulting in long-lasting restoration of the function.

The Phase 1 study was conducted at Rush University Medical Center, Chicago and UCSD. The open-label study involved 10 subjects with mild-to-moderate Alzheimer's disease. The administration of CERE-110 was generally safe and well tolerated. The 10 participants underwent cognitive testing, measures of activities of daily living, MRI scans and PET (positron emission tomography) scans. Increases in brain metabolism were observed in several cortical regions at six months and 12 months (p < 0.05) in four subjects as compared to other severity-matched individuals with Alzheimer's disease suggesting a potential reversal of patterns typically obser
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SOURCE Ceregene, Inc.
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