Contact: Tim Gehret
843.792.2626
July 13, 2006
Charleston -- The Medical University of South Carolina (MUSC) announced today that results of a Phase 2 trial of an investigational drug for the treatment of Alzheimer's disease, known as Flurizan™, were presented today by Jacobo Mintzer, M.D., Professor in the Departments of Neurosciences, Psychiatry and in the MUSC Center on Aging, as well as Staff Physician at the Ralph H Johnson Veteran Administration Medical Center. The results were presented during the 10th International Conference on Alzheimer's disease and Related Dementias, in Madrid, Spain. The presentation described the occurrence and timing of serious psychiatric events in patients with Alzheimer's disease, an analysis included in the overall clinical trial of the safety and efficacy of the drug candidate Flurizan, from Myriad Genetics, Inc. of Salt Lake City, Utah.
This disease measure is known as Time to Psychiatric Events (TPE) and monitors patients for the occurrence of psychiatric problems such as agitation, aggression, confusional state and depression. Over the course of the 12-month study, it was found that approximately 35% of participants taking placebo experienced such an event. However, patients with mild Alzheimer's disease that took 800 mg BID Flurizan twice daily had significantly fewer events (14%, p=0.020). In addition, the time that elapsed prior to the occurrence of such an event was significantly longer with patients on Flurizan than those on placebo (333 days for Flurizan versus 106 days for placebo, p=0.011), suggesting that Alzheimer's disease patients on Flurizan worsened more slowly than those on placebo.
"The decrease in number of psychiatric events and the dramatic lengthening in time before patients experienced such events while on Flurizan is an important feature for spouses and caregivers of Alzheimer's patients, as well as for the patients themselves," said Mintzer. "These events can be as troubling as the more widely recognized memory loss and decline in cognition, to those involved in the devastating deterioration caused by Alzheimer's disease."
About Flurizan for the Treatment of Alzheimer's Disease
Based on the positive Phase 2 results, Myriad is enrolling patients with mild Alzheimer's disease for a Phase 3 trial, at 130 centers across the United States. The Phase 3 trial is a double blind, placebo-controlled trial. Patients will be randomized into one of two arms, receiving either 800 mg of Flurizan or placebo twice daily for the duration of the 18-month trial period. The study is designed to determine Flurizan's ability to reduce the rate of cognitive decline and activities of daily living in patients with mild Alzheimer's disease, as measured by the ADAS-cog test and the change in ADCS-ADL, respectively. Information on participation is available by calling (888) 459-4888.
About Flurizan
Flurizan is the first in a new class of drug candidates known as Selective Amyloid beta-42 Lowering Agents (SALAs). Flurizan lowered levels of Abeta42 in cellular assays and animal models. Abeta42 is the primary constituent of senile plaque that accumulates in the brain of patients with Alzheimer's disease. It is thought to be the key initiator of Alzheimer's disease, since Abeta42 has the greatest tendency to aggregate, cause neuronal damage and initiate amyloid deposits in the brain. Most genetic mutations that cause early-onset Alzheimer's disease appear to do so by increasing production of Abeta42.
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