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news.Biotechnology Ceregene has completed enrollment of its Phase II clinical trial evaluating CERE-120, a gene therapy product in development for the treatment of Parkinson’s disease. The trial enrolled 58 patients in advanced stages of the disease across nine medical centers in the US.
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The company expects to announce results from the trial in late 2008. CERE-120 is designed to deliver the neurturin gene, a nervous system growth factor with the ability to maintain the growth and normal function of dopamine-producing neurons which deteriorate in Parkinson’s disease.
The Phase II trial, which was supported in part by The Michael J. Fox Foundation for Parkinson’s Research, was prompted by positive results from a Phase I study of CERE-120 which demonstrated a 36% reduction in Parkinson’s symptoms at 12 months after administration.
Jeffrey Ostrove, president and CEO of Ceregene, said: “Completing full enrollment of this multi-center controlled trial represents an important milestone in CERE-120’s development as well as in the development of Ceregene as an emerging biotechnology company. We are encouraged by the positive results from our Phase I trial and carefully designed this Phase II study as a controlled trial to confirm those results. With positive results from the Phase II study, we would expect to initiate a Phase III trial for CERE-120 in 2009.”