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www.fdanews.com/articles/91214-myriad-genetics-enrolls-patients-in-alzheimer-s-study

MYRIAD GENETICS ENROLLS PATIENTS IN ALZHEIMER'S STUDY

March 21, 2007

Myriad Genetics has completed enrollment of patients in its global Phase III clinical trial of Flurizan for treating Alzheimer's disease.

The trial, ActEarliAD, is a multinational, randomized, double-blind, placebo-controlled study of Flurizan (tarenflurbil) in more than 800 patients with mild Alzheimer's disease, who will be followed for 18 months. Patients enrolled in the study take 800 mg twice daily of either Flurizan or placebo and attend periodic physician visits for analysis of their performance on memory, cognition and behavioral tests.

The two primary clinical endpoints of the trial are the change in cognitive decline and function, as measured by the Alzheimer's Disease Assessment Scale cognitive subscale, and changes in activities of daily living, as measured by the Alzheimer's Disease Cooperative Study Activities of Daily Living inventory. A secondary endpoint of the trial is the change in overall function, measured by the Clinical Dementia Rating sum of boxes test.

The trial is designed to meet the requirements of the European Medicines Agency for marketing approval of Flurizan in Europe.

As was the case with the Phase II study, all patients in the Phase III studies are permitted to take current standard of care medicines in addition to Flurizan or placebo, provided their doses have been stable for six months. The company completed enrollment in the U.S. Phase III trial in August 2006.

Flurizan is the first in a new class of drugs known as selective amyloid lowering agents, according to the company.