AVICENA TO BEGIN PHASE III STUDY OF PARKINSON'S DRUG
Avicena has completed the dose-escalating portion of a chronic toxicology study of PD-02, its lead Parkinson's disease drug candidate. The results, which demonstrated that PD-02 is safe and well tolerated, will allow Avicena to proceed with patient enrollment in a Phase III Parkinson's disease study.
The FDA approved a Phase III study design for PD-02 in April 2006 and requested a dose-escalating chronic toxicology study of the drug prior to patient enrollment. This Phase III study is designed to evaluate PD-02's potential to slow the progression of Parkinson's disease and will be funded by the NIH's National Institute of Neurological Disorders and Stroke.
In March 2006 the company reported results of a Phase II randomized, multicenter, double-blind trial that enrolled 200 untreated Parkinson's disease patients. After 12 months of daily treatment, investigators found that the rate of disease progression for both PD-02 and minocycline was lower than the threshold for futility, as measured by the Unified Parkinson's Disease Rating Scale.
PD-02 is Avicena's proprietary therapeutic that has demonstrated the potential to improve neurological function in patients with Parkinson's disease. In preclinical studies, PD-02 has demonstrated significant neuroprotective properties including protection of the dopaminergic cells, which are affected in Parkinson's disease.