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PDF Statement on CERE-120 Trial Disappointment


Colleagues, Friends and Visitors to the PDF Website:
We have just learned that the widely-watched clinical trial of a potential new gene therapy treatment for Parkinson’s disease (PD) has shown no evidence that the treatment is effective.
Ceregene Inc., the company that was testing the efficacy of CERE-120, reported today that a Phase II trial testing the efficacy of the treatment “did not demonstrate an appreciable difference” between patients with Parkinson’s disease (PD) treated with CERE-120 and the members of a control group that received sham surgery.  A total of 58 people were part of the trial testing CERE-120, which is composed of a viral vector carrying the gene for neurturin, a naturally occurring protein that helps neurons to remain alive and healthy.  Researchers had hoped to harness neurturin's ability to protect the neurons lost and damaged by Parkinson’s disease, potentially easing the symptoms of PD.  

Many members of the Parkinson’s community had pinned hope on the experimental treatment and its potential to ease the symptoms of Parkinson’s.   Jeffrey Ostrove, Ph.D., Ceregene’s president, expressed his thanks on behalf of the company to the patients, physicians and staff who participated in the trial, and said he “shared their disappointment.”
We at PDF are also deeply disappointed, on behalf of the many thousands of people with Parkinson’s who look to us for guidance and of the scientists with whom we work.  The trial was one of the most promising around, and it was in the hands of principled, professional people and gifted scientists.  Our hearts go out especially to the courageous men and women who participated in the trial.
The news offers us yet another lesson – the latest, I am afraid to say, in a string of such lessons over the past several years – in how difficult, how uncertain, how frustrating, is the process of clinical research.  In the cause of making sure that every new treatment that hits the market is both safe and effective, we live by a process that takes years to deliver results, costs millions of dollars, and is always subject to potential disappointment.  But hard as it is sometimes to admit, we do not have an acceptable alternative to the randomized, double-blind, placebo-controlled trial, and we must live by its results. 
The company has not yet released the data from trial, and so we have nothing further to report to you at this time.  As soon as we learn more, we will be sure to post it on this site.
On a brighter note, I remind you that the Ceregene trial is not the only game in town.  In two recent articles that appeared in the PDF newsletter* – one authored by David Sommer, M.D., M.P.H., and Mark Stacy M.D., of Duke University and the other by Marina Emborg M.D., Ph.D., of the University of Wisconsin – some of the new directions in research were summarized.  You may find it heartening to check them out.
Robin Elliott
Executive Director, Parkinson’s Disease Foundation

*Articles from recent PDF newsletters:

Medications for Parkinson's Disease: What's on the Horizon?

A New Generation of Anti-Parkinson Treatments: Are We There Yet?


Source Date: Nov 26 2008