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news.Prana Biotechnology has completed a phase I trial with its lead compound, PBT2, under development as a therapy for Alzheimer's disease. In the trial the compound proved to be safe and well tolerated.
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Data from the study showed PBT2 was well tolerated with little difference in the incidence of adverse events between those receiving PBT2 and those receiving the placebo.
In addition, the pharmacokinetic analysis demonstrated that the drug exposure increased predictably and in a linear manner, both of which are excellent characteristics for a central nervous system drug. Concurrent preclinical findings also firmly indicated that PBT2 passes into the brain with more than 20 times greater efficiency than its predecessor, PBT1.
The double blind, placebo-controlled single dose escalation study, conducted at a facility in Utrecht in the Netherlands on 55 healthy, male volunteers between the ages of 18 and 50, was designed to evaluate the safety, tolerability and pharmacokinetics of PBT2.
“The clinical and preclinical results to date are compelling,” said Ross Murdoch, COO. “The trials confirm our laboratory studies showing that PBT2 has great potential for the treatment of Alzheimer’s disease, which currently affects 4.5 million people in the US and more than 14 million people worldwide.”