Prana completes Alzheimer's phase I
Tuesday, 07 February, 2006
Melbourne's Prana Biotechnology (ASX:PBT, Nasdaq:PRAN) has successfully completed a second phase I trial of its lead compound PBT2, under development as a therapy for Alzheimer's disease.
This PBT2 phase I trial marks the end of Prana's planned phase I clinical program prior to proceeding to phase II testing. Initial analysis indicates that PBT2 has a safety and pharmacokinetic profile suitable for further development - the full data analysis is scheduled for completion in March 2006.
"We are very pleased with the way PBT2 has performed to date," said Prana executive chairman and CEO Geoffrey Kempler in a statement. "The results for the human safety trials reinforce our belief that PBT2, Prana's lead MPAC (metal-protein attenuating compounds) possesses the attributes to allow it to be the first drug on the market that targets the beta-amyloid protein to treat Alzheimer's disease. It also bodes very well for Prana's other MPAC's that have been designed to treat a wide range of age-related neurodegenerative diseases."
The phase I, multi-dose, double blind, placebo-controlled, dose escalation study was conducted in The Netherlands on 32 healthy male and female volunteers between the ages of 45 and 75. The study was designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of PBT2 administered once daily for seven days. Initial results indicate that multiple doses of PBT2 are generally well tolerated by both male and female subjects in the critical target age group for Alzheimer's disease treatment.
Dr Ross Murdoch president and chief operating officer said, "We have previously stated that we would like to be in a position to start phase II trials in 2007 but obviously we are investigating the possibilities of starting earlier but we must complete toxicology and manufacturing development before we can make a decision."
Prana successfully completed the first phase I study on 55 younger healthy, male volunteers between the ages of 18 and 50 in November last year.
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