Prana says phase I trial of Alzheimer's therapy well-tolerated, shows promise

By E. Janene Geiss

Philadelphia, Nov. 7 - Prana Biotechnology Ltd. said Monday that is successfully completed the phase I trial of its lead compound, PBT2, under development as a therapy for Alzheimer's disease.

The double-blind, placebo-controlled single dose escalation study was conducted at a facility in Utrecht, the Netherlands, on 55 healthy male volunteers between the ages of 18 and 50, according to a company news release.

It was designed to evaluate the safety, tolerability and pharmacokinetics of PBT2, officials said.

Data showed the PBT2 was well-tolerated with little difference in the incidence of adverse events between those receiving the drug and those receiving the placebo. In addition, a pharmacokinetics analysis showed that the drug exposure increased predictability and in a linear manner, both of which are excellent characteristics for a central nervous system drug, officials said.

Pre-clinical findings also show that PBT2 passes into the brain more than 20 times greater than its predecessor, PBT1, officials said.

The company's chief operating officer called the clinical and pre-clinical results "compelling."

"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 U.S. and more than 14 million people worldwide," chief operating officer Ross Murdoch said in the release.

Prana scientists discovered a common interaction of metals and proteins leading to oxidative damage to the brain that is characteristic of patients with Alzheimer's disease, Parkinson's disease and other neurodegenerative disorders, officials said.

MPAC's (Metal Protein Attenuating Compounds), of which PBT2 is the lead compound, target abnormal protein-metal interactions, preserving normal metal biochemistry.

Prana is based in Parkville, Victoria, Australia, and was established to commercialize research into Alzheimer's disease and other major age-related degenerative disorders.

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