Prana heading for the clinic

Melbourne brain-drug developer Prana Biotechnology (ASX:PBT, NASDAQ:PRAN) will move its is lead Alzheimer's disease drug PBT-1 (clioquinol) into a Phase II/III clinical trial in the first half of next year, with the aim of carving up to three years from the time required to deliver the drug to the clinic.

The 52-week PLACQUE (Progression Limiting in Alzheimer's: ClioQUinol's Efficacy) trial, will be directed by Dr Craig Ritchie, of the Royal Free Campus at University College, London.

The company made its decision on the basis of encouraging results from its original Phase IIa trial of clioquinol.

The differences in the rates of predicted versus actual decline suggest that PBT-1 is actually modifying the course of the disease, as predicted from its metal-chelating activity, in contrast to current current commercial drugs that provide a transient benefit by stimulating cholinergic nerve activity.

The new trial will enrol 435 patients with advanced to severe dementia from Australia, the UK and South Africa, under double-blind conditions. Patients will be randomly assigned to a placebo group, and two experimental groups, who will receive either 125mg or 250mg of clioquinol daily. Prana said it expected the results from the trial to be available sometime in 2006, but will provide updates as it progresses.

CEO Dr Jon Alsenas said the new study will allow Prana to make a substantial leap of two to three years in achieving "potentially pivotal results" with its metal protein attenuating compound (MPAC) platform.

The company also plans to take its second-generation metal-chelating drug into a phase I trial in 2005.

Alsenas said that securing a patent on PBT-1 in August has enabled the company to move from being an early-stage, preclinical company to a late-stage company with a drug in advanced clinical trials.

He said that by early next year, Prana will have two very promising Alzheimer drugs in clinical trials - the company is planning a Phase I clinical trial of its second-generation metal-chelator, PBT-2, a product of its own synthesis program.