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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

SAN DIEGO, Nov. 4 /PRNewswire/ -- Ceregene, Inc., a biopharmaceutical company, today announced that the University of California, San Diego (UCSD) has received a $5.4 million grant from the National Institute of Aging at the National Institutes of Health (NIH) to support a Phase 2 clinical study of Ceregene's CERE-110, a gene therapy product designed to deliver nerve growth factor (NGF) for the treatment of Alzheimer's disease. A Phase 1 study of CERE-110 indicated that a single administration of the therapy was well tolerated, though the study was too small to make a definitive statement about treatment efficacy.

Ceregene anticipates initiating the Phase 2 study, which is expected to enroll 50 patients with mild to moderate Alzheimer's disease at multiple clinical trial sites in the U.S. early next year. The study will be double-blinded and will evaluate the treatment arm versus an appropriate control arm with respect to safety measures and cognitive function and quality of life at two years.

"We are pleased to be involved in evaluating CERE-110 which we believe may be a promising therapy for Alzheimer's disease," stated Paul Aisen, M.D., principal investigator of the planned Phase 2 trial and director of the Alzheimer's Disease Cooperative Study at University of California, San Diego, a preeminent research consortium for testing new treatments for Alzheimer's disease. "Over five million people in the U.S. are currently living with Alzheimer's disease -- a disease which is devastating to patients and their families -- and we are in need of more effective treatment options for these patients."

"The safety profile that we have observed from CERE-110 in the Phase 1 study is very encouraging, and we are delighted that this NIH grant will enable us to further evaluate this product candidate. We are especially grateful for this funding given that it was based on peer review, and we look forward to using it to advance this product. The developm
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SOURCE Ceregene, Inc.
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