Prana Doses First Patient in the “IMAGINE” Phase II Alzheimer’s Disease Trial
Melbourne – 6 March, 2012: Prana Biotechnology (NASDAQ:PRAN; ASX:PBT) today announced that the first patient has been dosed in the “IMAGINE Trial” – 12 month Phase II Imaging trial testing PBT2, the Company’s drug in development for Alzheimer’s Disease.
In the “IMAGINE trial” PBT2, a drug that significantly changed Abeta levels in spinal fluid and significantly improved the cognition of Alzheimer’s Disease patients in an earlier 12 week clinical trial, is now being assessed in a 12 month study for its effects on the distribution of amyloid in the brain and cognitive and functional improvement. The data on PBT2 from the preceding clinical trial has been published in Lancet Neurology and Journal of Alzheimer’s Disease.1,2,3
“We believe that in this 12 month trial PBT2 will establish its credentials as a safe and effective treatment for Alzheimer’s Disease”, commented Prana’s Executive Chairman, Mr Geoffrey Kempler.
The double blind placebo controlled trial is being conducted on 40 patients with prodromal or mild Alzheimer’s Disease. Patients on the trial have been screened using PiB-PET scanning to confirm pre-dosing levels of amyloid in the brain before receiving a single oral capsule of either PBT2 or placebo per day. The Protocol Synopsis can be viewed herea.
The trial has received funding from the Alzheimer’s Drug Discovery Foundation (ADDF). Howard Fillit, MD, the ADDF’s Executive Director commented that “PBT2 stands out as one of the few remaining orally available agents with clinical trial evidence of cognitive benefit for Alzheimer’s patients. Success in this trial will demonstrate target engagement by PBT2 in the brains of people with Alzheimer’s Disease, and accelerate the clinical development of PBT2 to patients”.
The scientific data supporting the belief that PBT2 will bring meaningful clinical benefit to patients is extensive. PBT2 restores neuronal health by selectively binding and redistributing brain metals (copper, zinc) that have become imbalanced due to disease or the ageing process. Furthermore PBT2 is able to prevent Abeta induced toxicity and promote its disaggregation in the brain. A position paper on PBT2’s differentiated mechanism of action relative to other drugs in development can be viewed hereb.
Alzheimer’s Disease and dementia affects over 26 million people worldwide. The cost to society has been reported as $600 billion per annum. Currently all available treatments are approved to provide some degree of symptomatic relief. None change the course of the disease and the eventual decline in patient’s cognition and health. PBT2 has the potential to be an effective treatment for AD that is supported by an extensive body of scientific and clinical work.
Patient enquiries should be directed to a dedicated IMAGINE Trial telephone number (Australia) 1800 83 76 83. The trial is being conducted at sites in Melbourne, Australia.
Clinical data available at: http://www.anzctr.org.au/ACTRN12611001008910.aspx
Mechanism paper available at:
Lannfelt et al. “Safety, Efficacy, and biomarker findings of PBT2 in targeting Abeta modifying therapy for Alzheimer’s disease: a controlled phase IIa, double-blind, randomized, placebo- controlled trial”, Lancet Neurology (2008) vol. 7, pp. 779-86.
Lannfelt et al. Errata: Lancet Neurology (2009) vol. 8, pp. 981.
Faux et al “PBT2 Rapidly Improves Cognition in Alzheimer's Disease: Additional Phase II
Analyses”, Journal of Alzheimer’s Disease (2010) vol. 20 pp. 509-516