Prana Receives Approval For 12-Month Open Label Extension Study In Alzheimer’s Disease
Melbourne – Wednesday, 3 July, 2013: Prana Biotechnology (NASDAQ:PRAN; ASX:PBT) today announced that it has received approval from the Austin Health Human Research Ethics Committee (HREC) to commence a 12-month open label extension study with Alzheimer’s Disease patients participating in Prana’s IMAGINE trial.
The approval follows a full review by Austin Health HREC of the potential benefit to patients and safety data collected during the ongoing IMAGINE trial, a 12-month double-blind Phase II clinical trial of PBT2 in Alzheimer’s patients. Fifteen percent of participants in IMAGINE have now finished the full 12 months of treatment and one hundred percent have completed at least 6 months of treatment.
Patients who have completed the full 12-month term of the IMAGINE trial are eligible for participation in the open-label extension study. All participants in the extension study will receive a 250mg once daily oral dose of PBT2 for an additional 12 months, with the first patient expected to start next month.
Prana’s Chairman and CEO, Geoffrey Kempler, said “We are keenly looking forward to the completion of the current IMAGINE trial to see the effects of PBT2 over 12 months, and we expect to report the results in March 2014. This will allow us to take the steps necessary to progress the commercialisation of PBT2 for Alzheimer’s. What is so helpful about the open- label study is that it will provide ongoing information to support the safety, tolerability and efficacy of PBT2 over a 24 month period”.
The open-label extension study protocol will closely follow the IMAGINE protocol, measuring amyloid burden and physical changes in the brain of Alzheimer’s patients, through PET imaging, MRI and FDG-PET, as well as cognition and function. The protocol synopsis appears below in Appendix 1.