2005 - Myriad Genetics Initiates Phase 3 Clinical Trial of Flurizan(TM) in Alzheimer's Disease
SALT LAKE CITY, Jan. 12 /PRNewswire-FirstCall/ -- Myriad Genetics, Inc.
(Nasdaq: MYGN), announced today that it has initiated enrollment in a Phase 3 human clinical trial of its lead therapeutic candidate, Flurizan(TM)
(MPC-7869), in patients with Alzheimer's disease.
The Phase 3 trial is designed to determine Flurizan's ability to alter the course of cognitive decline and behavioral change in patients with Alzheimer's
disease. The trial will be conducted in approximately 750 patients with mild to moderate Alzheimer's disease, at approximately 100 centers in the United
States. The Phase 3 study is a double blind, placebo-controlled trial, with randomization of patients at enrollment into one of three arms. Patients will be given 400mg or 800mg of Flurizan twice daily or placebo twice daily for the
duration of the 12-month study period. The co-lead investigators for this trial are Robert C. Green, M.D., M.P.H., Associate Professor of Neurogenetics,
Boston University School of Medicine, and Lon Schneider, M.D., Professor of Psychiatry, Neurology and Gerontology, Keck School of Medicine, University of
Southern California.
"There is a critical need for drugs that modify the underlying disease mechanism and progression of Alzheimer's disease," said Dr. Schneider. "MPC-
7869 has the potential to do this with its effect on reducing amyloid beta levels. We hope to confirm this in a large, well-controlled clinical trial."
The primary efficacy endpoints for the trial will be the change in cognitive function, as measured by the ADAS-cog test, and the change in activities of daily living.
"Flurizan is an exciting drug candidate due to its potential to change the rate of decline in Alzheimer's disease patients," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "We are pleased to take the
opportunity to accelerate Flurizan's development timeline by initiating this Phase 3 trial."
Flurizan is currently being studied in a Phase 2 clinical study in approximately 210 patients with mild to moderate Alzheimer's disease. All patients have now been on drug for more than 9 months. The trial's Data Safety Monitoring Board has reviewed safety data from the trial each calendar
quarterly and has determined that the trial should proceed without change.
This Phase 2 trial is expected to conclude its clinical study period in March of 2005.
Flurizan is a Selective Amyloid Beta 42 Lowering Agent
Flurizan has been shown to modulate gamma-secretase and selectively lower levels of Amyloid beta 42, a toxic peptide that is believed to be a chief culprit in the cause of Alzheimer's disease. In transgenic mouse studies,
Flurizan has demonstrated the ability to reduce brain amyloid levels and prevent memory loss. Flurizan was selected during preclinical testing to avoid cyclooxygenase inhibition and its related side effects.
About Alzheimer's Disease
Alzheimer's disease is the most common form of dementia, and is characterized by the loss of mental function. According to the Alzheimer's Association, the disease affects 4.5 million individuals in the United States alone, and over 25 million people worldwide. Twenty-five percent of the
population over age 75 is affected, and this proportion increases to half of those over 85 years. Common symptoms include a gradual loss of memory, problems with reasoning or judgment, disorientation, difficulty in learning,
loss of language skills, and decline in the ability to perform routine tasks.
The areas of the brain that control memory and thinking skills are affected first, but as the disease progresses cells die in other regions of the brain.
Eventually, the person with Alzheimer's disease will need comprehensive nursing care. If the individual has no other serious illness, the loss of brain function itself will eventually cause death. There is a very large
unmet need for treatments that slow cognitive decline or prevent Alzheimer's disease. The most commonly prescribed drugs to treat the symptoms of Alzheimer's disease are acetylcholinesterase inhibitors. These drugs provide
a temporary increase in cognitive ability to patients but the course of the underlying disease is left unchanged and cognitive decline soon continues.
The United States market for acetylcholinesterase inhibitors is estimated at $1.5 billion per year.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on
the Company's Web site at myriad.com.
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