PRANA RECEIVES CLINICAL TRIALS AUTHORIZATION IN UK TO INITIATE PLACQUE PHASE II/III STUDY

Prana Biotechnology has received a clinical trials authorization from the Medicines and Healthcare Products Regulatory Agency of the UK to initiate the potentially pivotal PLACQUE (Progression Limitation in Alzheimer's: ClioQUinol's Efficacy) Phase II/III clinical trial.

The PLACQUE trial will be conducted over 52 weeks and will enroll 435 patients in the UK, Australia and the Republic of South Africa. The purpose of the study is to assess the efficacy of two dose levels of PBT-1 (clioquinol) when added to the current therapy of patients with moderate Alzheimer's disease. The trial will be randomized, double-blind and placebo-controlled.

The primary endpoint of the study will be to demonstrate a reduction in the progression of Alzheimer's as measured by the Alzheimer's Disease Assessment Scale-cognition.