Alzheimer's Disease - Report On PBT2 Phase I Trial
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Prana Biotechnology Limited (Nasdaq: PRAN; ASX: PBT), has received an independent report in respect of the Phase I trials with its lead proprietary compound, PBT2, under development as a therapy for Alzheimer's disease.The Phase I clinical trial program for PBT2 investigated the safety/tolerability and pharmacokinetics of single and multiple oral doses of PBT2, in 55 young male volunteers (18-45 years) and 32 older male and female volunteers (45 to 75 years). Full data analysis for both clinical studies is complete and the data is being prepared for publication. Plans are underway for a Phase II clinical trial."Having reviewed the safety and pharmacokinetic profile for PBT2 from the two Phase I studies, it certainly appears that the drug is generally well tolerated at doses to 800mg. In both studies, there were no significant differences in overall rates of adverse effects between PBT2 and the placebo groups and there appears to be no relationship between dose and rate of adverse effects. Of the adverse effects that were seen, the vast majority of these were thought to be unrelated to PBT2 treatment. Of the few that were possibly related, they appeared mild and self limiting. The Phase I results provide the confidence needed to move forward to formal Phase II testing in people with Alzheimer's disease," said Dr. Craig Ritchie, psychiatrist and Director of Mental Health Clinical Trials at University College London and Prana clinical advisor.