Results, which demonstrated that the drug 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 prior to patient enrollment. This study is designed to evaluate PD-02’s potential to slow the progression of 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.