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Sangamo BioSciences Announces Presentation Of Clinical Data From Alzheimer's Disease Program
Date:11/15/2013

ct, has proved challenging due to the blood brain barrier. Gene therapy with AAV, combined with stereotactic surgery, enables delivery of the gene encoding a biologically active protein such as NGF to a precise location in the brain.  The nucleus basalis of Meynert (NBM), a structure near the base of the brain, is considered to be the best target for delivery of a gene-based therapeutic for AD as its cells represent the primary source of cholinergic nerves projecting to the brain cortex. Thus, a single treatment of CERE-110 into this structure is expected to provide a safe long-term source of NGF protein that may protect and preserve cholinergic cells in the brains of AD patients and potentially slow disease progression.

About the CERE-110 Phase 1 Study and Summary of Data Presented at the CTAD Meeting
Ten subjects (10) with mild to moderate AD were treated with a single administration of CERE-110 in an open-label dose-escalation study to evaluate three different doses of the therapeutic (two dose cohorts of three subjects each and the third, highest dose, of four subjects).  The drug was delivered by standard stereotactic surgery into the NBM and subjects were followed for 24 months.  The trial was designed to evaluate safety and tolerability, and signs of efficacy.

The data demonstrated that:

  • The treatment is feasible and well tolerated.  Serious adverse events (SAEs) were transient, acceptable and related to the surgical procedure.  AEs were not dose-related and not related to either the AAV or NGF
  • Long term expression of NGF was observed in brain tissue, with desired changes in neuronal cell volume of targeted neurons providing evidence of bioactivity
  • Preservation of glucose utilization, as measured by 18FDG (Fludeoxglucose) Positron Emission Tomography (PET) brain imaging, was observed through the 24 months of the study suggesting that
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SOURCE Sangamo BioSciences, Inc.
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