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Enrollment on target in Parkinson’s trial

A study co-led by MUSC of a drug that could slow the progression of Parkinson’s disease is on target with patient enrollment, according to drug-maker Avicena Group Inc., which develops central nervous system therapeutics for neurodegenerative diseases.
 
The Phase III trial for the drug candidate, PD-02, is sponsored by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke, and has enrolled 288 patients so far.
 
Ultimately, this phase of the trial will enroll more than 1,720 patients at more than 50 sites in the United States and Canada, making it one of the largest Parkinson’s disease trials ever conducted. The lead investigators are MUSC’s Barbara C. Tilley, Ph.D., Distinguished University Professor, Department of Biostatistics, Bioinformatics and Epidemiology chair, and Karl Kieburtz, M.D., of the University of Rochester in New York.
 
“The rapid pace of enrollment underscores the unmet treatment need among 1 million Parkinson’s disease sufferers in the U.S.,” said Belinda Tsao-Nivaggioli, Ph.D., Avicena’s chief exe-cutive officer.
 
PD-02 is a proprietary thera-peutic for the treat-ment of Parkinson’s disease. Data from Phase II efficacy trials conducted at the University of Rochester showed PD-02 to be safe and well tolerated. Furthermore, findings demonstrated PD-02’s potential to slow the rate of disease progression as measured by the Unified Parkinson’s Disease Rating Scale. Results were published in the Journal of Neurology. In preclinical studies of Parkinson’s disease, PD-02 has demonstrated significant neuroprotective properties including protection of the dopaminergic cells that are affected in Parkinson’s disease.
 
Parkinson’s disease is an incurable, progressive and neurodegenerative brain disorder that occurs when the neurons that are responsible for producing the chemical dopamine die. Primary symptoms of the disease include involuntary shaking of the arms or legs (tremors), difficulty with balance, slowness of movement, and stiffness.
 
The Parkinson’s Disease Foundation reports that roughly 1.5 million Americans are affected by Parkinson’s disease, making it the second most common neurodegenerative disease after Alzheimer’s disease. About 60,000 new cases are diagnosed each year in the United States.

   

Friday, Aug. 3, 2007
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