Avicena begins large scale Ph III PD study

California, USA-based biotechnology firm Avicena says that it has initiated a trial of its developmental Parkinson's disease drug PD-02, an ultrapure form of creatine. The trial, which coincides with PD awareness month in the USA, is being conducted in collaboration with the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.

Avicena explained that the assessment is designed to test the efficacy and safety of PD-02 when used to improve neurological function and slow disease progression in PD sufferers. In total, the program will seek to enroll over 1,700 patients at around 50 sites in the USA and Canada. The Palo Alto-headquartered company added that data from previously-reported studies suggest that, unlike currently-available PD therapies that solely address symptoms of the condition, PD-02 may slow disease progression as measured by the Unified Parkinson's Disease Rating Scale (Marketletter March 20, 2006).

The firm said that, as part of its ongoing agreement with the NINDS, it will supply stocks of PD-02 and placebo for use in the study, in return for the right to include the resulting data in a future New Drug Application it intends to file with the Food and Drug Administration.