Prana's PBT2 Phase II Trial Receives Funding From Alzheimer's Drug Discovery Foundation
The New York based Alzheimer's Drug Discovery Foundation (ADDF) and Prana Biotechnology has jointly announced that the ADDF will provide Prana with a mission-related investment of US$700,000 over two years to conduct a clinical trial investigating the potential of PBT2 to reduce the accumulation of beta-amyloid in the brain of people with Alzheimer's Disease (AD).
Beta-amyloid is thought to be a cause of brain cell death and dementia in Alzheimer's Disease. The Phase II study will enroll 40 patients with mild AD for 12 months, with Positron Emission Tomography (PET) amyloid neuroimaging and other biomarkers as the primary outcome measures.
Howard Fillit, MD, the ADDF's Executive Director commented that "PBT2 stands out as one of the few orally available agents with clinical trial evidence of cognitive benefit for Alzheimer's patients. If this Phase II trial is successful, it will further demonstrate target engagement by PBT2 in the brain of people with Alzheimer's Disease. It is hoped that these additional data will accelerate the clinical development of PBT2 to patients."
Previously PBT2 demonstrated a significant decrease in beta-amyloid in the cerebrospinal fluid and significantly improved executive function in mild Alzheimer's Disease patients within three months of treatment*. The ADDF funded Phase II study will ask the question, 'what is happening to the amyloid burden of these patients using the same dose that previously resulted in cognitive improvements, and is this change sustainable?' Since the number of patients in the study is relatively small, cognitive function will be included as a secondary outcome measure.
"We are honored to be selected for funding by the ADDF, an organization that is internationally recognized as supporting some of the most ground breaking drug discovery and development research today in Alzheimer's Disease," said Mr. Geoffrey Kempler, Prana's Executive Chairman.
Kempler continued, "The trial will advance our understanding of PBT2's potential mechanism of action for disease modification in humans, a critical step forward that complements our strategic plan to advance PBT2 through clinical trials for the treatment of both Alzheimer's and Huntington's Disease."
The Phase II trial is planned to commence in Australia in the second half of 2011. It will recruit patients with mild Alzheimer's Disease who have demonstrated evidence of amyloid burden in the brain by PET-amyloid imaging.