Prana Provides Update on PBT2 Alzheimer’s Disease Extension trial
83% of patients completing treatment in IMAGINE trial Opt to Join Extension
MELBOURNE, December 11, 2013: Prana Biotechnology (ASX:PBT; NASDAQ:PRAN), a developer of best-in-class treatments for neurodegenerative disease, today provided an update of its IMAGINE Alzheimer’s Disease (AD) Extension trial.
In July 2013, Prana announced that the Austin Health Human Research Ethics Committee (HREC) approved a 12-month open label extension study for patients completing the double- blind placebo-controlled IMAGINE trial. There is no placebo group in the Extension trial. All participants receive a once daily dose of 250mg of PBT2. PBT2 is Prana’s drug in Phase 2 development for Alzheimer’s and Huntington’s diseases. The approval followed a full review by the Austin Health HREC of the potential benefit to patients and safety data collected during the IMAGINE trial.
All patients in the IMAGINE trial were given the opportunity to participate in the Extension trial. Participation in the Extension study required patients to consent to receive PBT2 for 12 months following the end of the IMAGINE trial, as well as undergoing further brain scans, blood tests and cognitive testing.
On December 9, 2013 Prana announced that the treatment phase of the IMAGINE trial had completed with 95% of enrolled patients completing treatment (40 of a possible 42). Prana now confirms that a total of 33 patients chose to go into the Extension trial, representing 83% of the 40 patients who completed 12 months of treatment in the IMAGINE trial.
The independent Data Safety Monitoring Board recently met to review the available safety data from the Extension trial, and has recommended that the study proceed without change to the original protocol.