FDAnews
www.fdanews.com/articles/61906-myriad-completes-enrollment-in-alzheimer-s-drug-trial

MYRIAD COMPLETES ENROLLMENT IN ALZHEIMER'S DRUG TRIAL

August 22, 2006

Myriad Genetics has completed enrollment in its Phase III trial of Flurizan for patients with Alzheimer's disease. The trial is the largest placebo-controlled study ever undertaken of an investigational medicine in patients with Alzheimer's disease, with a total of approximately 1,600 patients enrolled.

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 in memory, cognition and behavioral tests. The trial is designed with an 18-month study period; however, an interim review of the data after 12 months has the potential to halt the trial early if exceptional results are achieved. All patients in the study are permitted to take current standard-of-care medicines in addition to Flurizan or placebo. Therefore, benefits seen in the trials are over and above any benefit provided by the current drugs.

Flurizan is the first in a new class of investigative drugs known as selective amyloid-lowering agents. This mechanism of action is different from the currently marketed drugs that provide only a limited, temporary cognitive boost without affecting the course of the disease itself. Flurizan does not inhibit COX1 or COX2 enzymes. The Phase II study showed that patients taking 800 mg twice daily continued to benefit over 24 months in tests of memory loss, cognition and behavior. In addition, those on Flurizan had a fewer psychiatric events such as aggression, depression, confusion and agitation.