Study explores gene transfer to modify underlying course of Alzheimer...( Investigators at Rush University Medica...)

Investigators at Rush University Medical Center have successfully initiated a new technique that uses gene therapy to deliver nerve growth factor into regions of the brain where neurons are degenerating, in order to prevent cell death and reverse cell atrophy, two hallmarks of Alzheimer's disease. If successful, this could be a major step toward modifying the course of the disease. Rush is the only center in this study.

The new technique uses CERE-110 as the gene therapy agent. CERE-110 carries the Nerve Growth Factor (NGF) gene encased in a harmless viral coating, which protects the gene and facilitates its delivery to brain cells. The active part of the drug is the NGF gene, the human DNA strand that codes for the NGF protein, a natural substance that exerts positive effects on brain cells. A key objective of the study is to deliver the CERE-110 directly to the part of the brain that is almost universally affected by Alzheimer's disease, the basal forebrain, and not to other parts of the brain where it may cause side effects.

The new drug, CERE-110, is being used by researchers at Rush as part of a Phase I study to evaluate its safety and tolerability using two different doses. Memory and cognitive function will also be assessed regularly during the two-year period of the study. Six to 12 subjects with mild to moderate Alzheimer's disease, based on the specific cognitive tests used to classify the disease stage, will be enrolled in the study.

The first patient in the study was treated on July 27. Dr. David Bennett and Dr. Zoe Arvanitakis of the Rush Alzheimer's Disease Center are the co-principal investigators. Bennett is director of the center. Ceregene, Inc., based in San Diego, (a minority owned subsidiary of Cell Genesys, Inc.) the developer and manufacturer of CERE-110, is funding the study.

Neurosurgery is required to precisely inject the drug into the nucleus basalis of Meynert on both sides of the brain. Dr. Roy Ba
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Contact: John Pontarelli
jpontare@rush.edu
312-942-5949
Rush University Medical Center
21-Sep-2004

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