About Phase 2 Trial of CERE-120
Ceregene's Phase 2 trial was a double-blind, controlled clinical trial that completed enrollment of 58 patients with advanced Parkinson's disease in November 2007. This study was launched after successful execution of an extensive nonclinical program and preliminary evidence of safety and efficacy in advanced Parkinson's patients via an open-label Phase 1 trial in 12 patients. Patients in the Phase 2 trial were enrolled across nine leading academic medical centers in the United States, with two thirds of patients receiving CERE-120 and one third enrolled into a control group. Patients received a single administration of CERE-120 via stereotactic neurosurgery to deliver the drug into the putamen region of the brain and were followed for 12 months for safety and efficacy.
CERE-120 is composed of an adeno-associated virus (AAV) vector carrying the gene for neurturin (NTN), a naturally occurring protein known to repair
damaged and dying dopamine-secreting neurons, keeping them alive and restoring
normal function. NTN is a member of the same protein family as glial
cell-derived neurotrophic factor (GDNF). The two molecules have similar
pharmacological properties, and both have been shown to benefit the midbrain
dopamine neurons that degenerate in Parkinson's disease and are responsible
for the major motor impairments. CERE-120 is delivered by stereotactic
injection to the affected area of the brain, providing stable, long-lasting
expression of NTN in a highly targeted fashion. Genzyme Corporation has
licensed the ex-North American rights for the development and
commercialization of CERE-120 from Ceregene, an agreement that was announced
|SOURCE Ceregene, Inc.|
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