Prana looking to partner on PBT2 for Alzheimer's following phase 2a clinical trial

By Jennifer Lanning Drey

Eugene, Ore., Aug. 11 - Prana Biotechnology Ltd. will look to establish a strategic relationship as it moves forward with clinical development of PBT2 for Alzheimer's disease, said Rudolph Tanzi, co-founding scientist of Prana, during a presentation at the Banc of America Specialty Pharmaceuticals Conference on Friday.

The company expects to begin its phase 2a clinical trial of the drug by the end of the year.

"The hope in moving forward in the clinical development is to establish a strategic relationship with Big Pharma for the further development of PBT2 into phase 2b and phase 3," Tanzi said.

The planned phase 2a clinical trial will evaluate the safety and tolerability of PBT2, as well as measure the drug's mechanism of action and indicators of potential efficacy in Alzheimer's disease.

The phase 2a study is a randomized, double-blind, placebo-controlled design, in which Alzheimer's disease patients will receive three months of one of three oral doses of PBT2, or a placebo.

The study will investigate the ability of PBT2 to affect multiple cerebrospinal fluid and blood biomarkers of Alzheimer's disease during the treatment period.

Outcomes will include measures of cerebrospinal fluid alpha, beta and tau levels as well as neurocognitive and behavioral changes.

If enrollment in the phase 2a clinical trial begins by the end of the year as scheduled, Prana expects to report data from it by the end of 2007, Tanzi said.

"The next 18 months are very important for the company," he said.

However, Prana has previously cautioned that it will be at least five to six years before a therapeutic could be developed for commercial sale.

Prana plans to use the phase 2a trial, along with data from a larger, pivotal clinical trial to try to accelerate PBT2's path to commercialization under European Medicines Agency regulations that allow for Conditional Marketing Authorization for treatments of seriously debilitating or life-threatening diseases that have no, or limited, treatment options, Tanzi said.

Prana Biotechnology is located in Melbourne, Australia.

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