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Ceregene Presents Interim Phase 1 Clinical Data of CERE-110 for the,Treatment of Alzheimer's Disease

SAN DIEGO, Calif., May 02, 2007 /PRNewswire/ -- Ceregene, Inc. today presented interim clinical data from a Phase 1 trial of CERE-110, a gene therapy product designed to deliver nerve growth factor (NGF) for the treatment of Alzheimer's disease. After one year of follow-up, the results for the six patients who received CERE-110 in the trial indicate that a single administration of the therapy was well tolerated, and an interim analysis suggested that the therapy had the potential to reduce the rate of cognitive decline and increase brain metabolism. These data were presented today by Zoe Arvanitakis, M.D., and David Bennett, M.D., co-principal investigators, Rush Alzheimer's Disease Center, Dept. of Neurological Sciences, Rush University Medical Center, at the American Academy of Neurology Meeting in Boston, Massachusetts.

The Phase 1 trial at Rush University Medical Center was a single-site, open-label study involving six patients with mild-to-moderate Alzheimer's disease and was conducted for the purpose of evaluating whether CERE-110-NGF administered by an adeno-associated viral gene delivery system-could be safely delivered. All six patients enrolled in the study underwent stereotactic neurosurgery to deliver CERE-110 into a specific region of the brain called the Nucleus Basalis of Meynert (NBM) -- an area that is a source for the production of cholinergic neurons, which are known to undergo profound degeneration in patients with Alzheimer's disease. The administration of CERE-110 was generally well tolerated.

The six patients underwent cognitive testing, and the data suggest that a reduction in the rate of cognitive decline may have been achieved. PET (positron emission tomography) scans were also obtained of the patients' brains at baseline, six and 12 months, and increases in brain metabolism were observed in several cortical regions at six months (p<0.05). Further increases in metabolism
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