Ceregene, Inc., a unit of Cell Genesys Inc. (CEGE), revealed additional clinical data from a double blind, controlled mid-stage trial of CERE-120 in 58 patients with advanced Parkinson's disease, a progressive movement disorder that affects a million people in the United States.
The company previously announced that the mid-stage trial did not meet its primary endpoint of improvement in the Unified Parkinson's Disease Rating Scale motor off score at 12 months of follow-up, although several secondary endpoints suggested a modest clinical benefit. CERE-120 uses AAV-based gene therapy; AAV has been considered as a safe vector for gene transfer and has been involved in many clinical trials to treat metabolic abnormalities, to deliver the neurotrophic factor, neurturin, to Parkinson's disease patients in order to restore the function and protect degenerating nigrostriatal neurons.
Additional, protocol-prescribed analyses focused on further analyses of the data from the 30 subjects who continued to be evaluated under double-blind conditions for up to 18 months, which indicate increasing effects of CERE-120 over time. A clinically modest, but statistically significant treatment effect in the primary efficacy measure as well as similar effects on several more secondary motor measures, were seen at the 18-month endpoint.
The analyses revealed that CERE-120 produced clear evidence of neurturin expression in the targeted putamen but no evidence for transport of this protein to the cell bodies of the degenerating neurons, located in the substantia nigra.
In addition to the known cell loss in Parkinson's disease, the findings suggest that deficient axonal transport in degenerating nigrostriatal neurons in advanced Parkinson's disease impaired transport of CERE-120 and/or neurturin from putaminal terminals to nigral cell bodies, reducing the bioactivity of CERE-120. The trial also indicated that CERE-120 appears safe when administered to advanced Parkinson's disease patients, with no significant concerns related to the neurosurgical procedure, the gene therapy vector, or the expression of neurturin in the Parkinson's disease brain.
CEGE is currently trading at $0.48 up $0.06, or 14.62% on a volume of 9.54 million shares on the Nasdaq.
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