Myriad Plans More Flurizan Tests
By Robert Steyer
TheStreet.com Staff Reporter
5/2/2005 11:55 AM EDT
URL: thestreet.com
Myriad Genetics (MYGN:Nasdaq) said Monday that a midstage clinical trial of an experimental Alzheimer's disease drug missed its goal. But the company added that it plans to conduct more advanced testing of the drug.
Myriad, of Salt Lake City, said patients with mild to moderate Alzheimer's disease receiving the drug Flurizan didn't show statistically significant benefits vs. patients taking a placebo. The test was designed to determine whether the drug could slow the progression of this memory-robbing disease.
However, Myriad noted that there was a "positive trend" among certain patients taking 800 milligrams of Flurizan twice a day vs. patients taking 400 milligrams twice a day.
Myriad said the 12-month study of 207 patients showed that some test goals achieved statistical significance for patients with a mild version of Alzheimer's disease. The clinical study measured three indicators of daily living and cognitive function.
"Even though Flurizan did not achieve significance in the primary endpoints of the phase II Alzheimer's disease study, we are encouraged by the statistically significant effect observed in the mild Alzheimer's disease patients," said Peter Meldrum, president of the company, in a prepared statement. Phase II is the second of three rounds of clinical trials before a company seeks approval from health regulators.
Meldrum said the company intends to continue its phase III trial, adding that the larger dose is the preferred amount. It will review the research guidelines with the clinical trial's principal investigators "to determine any modifications in treatment."
Myriad also will talk to health regulators about changing the test design to focus solely on enrolling patients with a mild form of the disease. It will continue to analyze the phase II data affecting patients with moderate Alzheimer's disease.
Shares of Myriad Genetics were up 30 cents, or 1.9%, to $16.46 on Monday.
Flurizan differs from most Alzheimer's disease drugs because it targets a toxic protein called beta amyloid, which researchers believe is linked to the development of plaque that accumulates in the brains of Alzheimer's disease patients. Researchers believe that if they can stop the development of plaque, they can stop the plaque from subsequently killing brain cells. Several companies are working on beta-amyloid-fighting drugs.
Most Alzheimer's disease drugs on the market are called AChE inhibitors. They include Reminyl from Johnson & Johnson (JNJ:NYSE) , Aricept from Pfizer (PFE:NYSE) and Japan's Eisai, and Exelon from Novartis (NVS:NYSE) .
These drugs are prescribed for mild to moderate Alzheimer's disease; the best they can do is slow the progression of the disease in some patients. AChE inhibitors prevent the breakdown of acetylcholine, a brain chemical that plays a key role in memory and other thinking functions.
Another drug on the market is Namenda from Forest Laboratories (FRX:NYSE) . Namenda is approved by the FDA for patients with moderate to severe versions of the disease. It works on glutamate, a brain chemical that helps the brain process, store and retrieve information. The drug appears to block the toxic effects of too much glutamate, allowing cells to function normally. Like AChE inhibitors, Namenda cannot halt the disease; it can only slow the progression in some patients. |
