Prana completes trial of PBT2 in Alzheimer's

Melbourne, Australia-based Prana Biotechnology has announced the successful completion of a second Phase I trial with its lead compound, PBT2, under development as a therapy for Alzheimer's disease.

This study marks the end of Prana's planned Phase I clinical program prior to proceeding to Phase II testing. Initial analysis indicates that PBT2 has a safety and pharmacokinetic profile suitable for further development; the full data analysis is scheduled for completion in March. The chronic toxicology studies and Good Manufacturing Practices development required for Phase II clinical studies are ongoing.

The Phase I, multi-dose, double blind, placebo-controlled, dose escalation study, was conducted in Utrecht, the Netherlands, on 32 healthy male and female volunteers between the ages of 45 and 75. The study was designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of PBT2 administered once-daily for seven days. Initial results indicate that multiple doses of PBT2 are generally well tolerated by both male and female subjects in the critical target age group for Alzheimer's disease treatment.