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Huntington's Disease

Prana Enrolls First Patient in the “Reach2HD” Phase II Huntington Disease Trial

Huntington Study Group initiates first site at University of California, San Diego School of Medicine

Melbourne – 30 April, 2012: Prana Biotechnology (NASDAQ:PRAN; ASX:PBT) today announced that the first patient has been dosed in the “Reach2HD Trial” – a 6 month Phase IIa clinical trial testing PBT2, the Company’s drug in development for Huntington disease. Reach2HD, a double blind placebo controlled study, is enrolling 100 patients with early to mid-stage Huntington Disease. The Principal Investigator on the study is Dr. Ray Dorsey of Johns Hopkins University.

Huntington disease is a complex and severely debilitating genetic, neurodegenerative disease, for which there is no cure. The disease often affects young adults and, whilst associated with severe physical movement symptoms, progressively impacts the mind and emotions as well. The disease causes incapacitation and death about 15-25 years after onset. The disease affects 30,000 people in the US and about 70,000 worldwide.

There is only one marketed drug for Huntington disease, with limited utility and notably there are no drugs either available or in development that have established clinical evidence for treating the cognitive decline associated with Huntington disease. In this study, Prana aims to demonstrate cognitive improvements as already demonstrated in a Phase IIa study in mild Alzheimer’s patients treated with PBT2*. The study will also investigate safety, functional, behavioural and motor benefits in this Huntington patient population.

Professor Ira Shoulson, Professor of Neurology, Pharmacology and Human Science at Georgetown University (Washington DC) and the Chair of the Executive Committee of the Huntington Study Group said “PBT2 attracted our attention as an experimental drug with the potential to bring real benefit to Huntington disease patients who suffer from a range of motor, behavioural and cognitive symptoms. The favourable signals from the PBT2 trial in Alzheimer’s disease are particularly promising”.

The trial will be conducted in approximately 20 sites across the US and Australia. For further information visit the HSG website PBT2 is concurrently being tested in a Phase II trial in Alzheimer’s disease.

*PBT2 has completed a Phase II trial in Alzheimer’s patients and significantly improved the Executive functioning of patients treated with the drug. Executive function is an integrated set of cognitive abilities, including thinking flexibility, concept formation, and self-monitoring. Executive function has overarching control of cognitive processes needed for organizing, strategizing, problem solving, verbal reasoning and multi-tasking. Loss of Executive function is the main cognitive loss experienced by those with Huntington disease.