Prana Receives Recommendation to Proceed with Alzheimer’s Clinical Trial from Data Safety Monitoring Board (DSMB)
Melbourne – September 12, 2012; Prana Biotechnology (NASDAQ:PRAN; ASX:PBT) today reported that it had received a recommendation from the Data Safety Monitoring Board (DSMB) that the IMAGINE trial for Alzheimer’s disease should continue as planned based on the initial review of clinical data. The DSMB is an independent group of experts who review the accumulated safety data in ongoing clinical trials, in order to safeguard the interests and safety of participating and future patients. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.
The IMAGINE trial is a double-blind placebo controlled trial enrolling 40 patients with prodromal or mild Alzheimer’s disease at five sites in Melbourne, Australia. Brain Imaging is being used to measure PBT2’s effect on amyloid deposits in the brain (using PiB-PET scanning) and effects on increasing brain activity (FDG PET). Cognition effects are being measured by the Neuropsychological Test Battery (NTB).
In the current IMAGINE trial:
- 100% of sites approved and open for recruitment;
- 45% of patients in dosing;
- Recruitment On Track to report 2H13;
- 3 patients have reached 28 weeks of dosing – over double the previous longest exposure to PBT2;
- No serious adverse events reported
In an earlier 12 week trial PBT2 both significantly changed amyloid levels in spinal fluid and improved the cognition of patients with Alzheimer’s disease. The IMAGINE trial, with 12 months of treatment, aims to establish PBT2 as a safe and effective treatment for Alzheimer’s disease.
PBT2 has a unique therapeutic action that can benefit people suffering neurodegenerative disease because of its specialized ability to prevent the toxic relationship between disease proteins and the metals, zinc and copper, in the brain
Prana is also conducting a 6 month trial in 100 patients with early to mid-stage Huntington disease and the company believes that PBT2 has the potential to bring real benefit to Huntington Disease patients who suffer from a range of motor, behavioural and cognitive symptoms. The trial objective is to demonstrate safety, motor and behavioural benefits and the same cognitive benefits for Huntington’s patients that it has already demonstrated in Alzheimer’s patients treated with PBT2.