New Clinical Trial Begins for Treatment of Parkinson's Disease

November 2010 Monthly Message
 
- New Clinical Trial Begins for Treatment of Parkinson's Disease
- Policy Focus
- A Natural Miracle, a Legal Morass, by Joel Havemann
- Highlights of Recent Parkinson's in the Media

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Ceregene, Inc., of San Diego, California announced on October 19 that the company has just begun a new Phase 2 study of CERE-120 for people with Parkinson’s disease.  This summer, Raymond Bartus, Ph.D., Executive Vice President and Chief Scientific Officer at Ceregene, participated in PAN’s Emerging Therapies:  From Microscope to Marketplace interactive Webcast where he discussed the importance of clinical trial participation and the development of the next generation of therapies and cures.  For an in-depth look at Ceregene’s new trial of CERE-120, please see this recent article, co-authored by Dr. Bartus, which appeared in PDTrials’ e-newsletter.  PAN is a long-time supporter of PDTrials, and continues to work with the Parkinson’s community to support new, safe, and speedy trials for emerging therapies.

Participation in all clinical trials is important.  Without members of our community and their willingness to assist in these trials, there would be no way for researchers to move science forward toward better therapies and a cure.  Whether you have the disease or know someone who does, it is hugely important that people know about this and other important trials. Their participation is crucial to success.

What is CERE-120?
CERE-120 is an experimental drug that contains the human gene for a growth factor called neurturin.  CERE-120 delivers the neurturin gene directly into the brain, where neurons are dying.  It has been shown to improve symptoms and to protect and improve the function of damaged brain cells in animal models.  That is why CERE-120 is thought to have the potential to improve symptoms of Parkinson’s and possibly slow progression of the disease.

“We have made several important improvements to the protocol and dosing methods in this new trial of CERE-120, based on what we learned from our initial, controlled Phase 2 trial,” stated Dr. Bartus.  “We greatly appreciate and respect the commitment of the people who participate in trials such as this.  We hope that people in the Parkinson’s community will join with us in volunteering to participate in this trial to help properly test whether CERE-120 might represent a new and effective next-generation tool to fight Parkinson’s disease.”

Is CERE-120 safe?
CERE-120 has been shown to be safe in animals and in previous studies in people with Parkinson’s.

CERE-120 was first tested in animals and then in two prior clinical trials (a Phase 1 safety study and a Phase 2 safety/efficacy study).  Following several improvements based on the data obtained from those studies, another Phase 1 study was more recently conducted and successfully completed in six people with Parkinson’s.  These three completed clinical trials of CERE-120 all continue to support the safety of CERE-120.  Currently, 52 patients treated with CERE-120 now have 2 to 5 years of exposure to CERE-120 and neurturin expression and the safety profile appears to be holding up long term.

How does someone participate in the study?
Enrollment of about 52 patients in the clinical trial is underway at 10 leading medical centers in the United States – in Alabama, California, Georgia, Illinois, North Carolina, New York, Pennsylvania, and Texas. 

If you are interested in participating, Ceregene has more information on who can enroll in the study.

How can people with Parkinson’s learn more about the study?
More information about CERE-120 or Ceregene, including contact information regarding enrolling in the trial, is available on Ceregene’s Web site.