Phase II trials had earlier shown Flurizan effective for 12 months, and a follow-on study of patients with mild symptoms of Alzheimer's showed the compound effective as long as 21 months and counting.
"This is further evidence that Flurizan stopped further decline in this group of patients," Myriad President Adrian Hobden said Monday. "We will be interested in seeing just how much further that carries. . . . It will bring huge hope to patients if that bears out."
The results set the stage for the largest Alzheimer's drug test to date, an 18-month Phase III clinical study for which Myriad is enrolling 1,600 patients nationwide.
Patients in the Phase II follow-on study were given either 800 milligrams or 400 milligrams of Flurizan, or a placebo. Those on 800 milligrams showed an increasing benefit in the areas of cognition, memory loss and everyday activities, compared with those on the 400 milligram dose or placebo.
Based on the positive testing results to date, Myriad is enrolling patients with mild symptoms of Alzheimer's disease for a Phase III trial at 130 sites across the United States, including Utah. Patients will be placed in two divisions, one receiving 800 mg of Flurizan and the other a placebo twice daily for the duration of the 12-month trial period. (To enroll, contact the company at its Web site, www.myriad.com)
Phase III, typically the final round of tests for candidate drugs, is expected to be under way this summer. Assuming continued positive results, Myriad hopes sometime in 2008 to see Flurizan enter the $4 billion Alzheimer's market.
It is estimated that more than 4 million Americans have Alzheimer's, a number expected to grow to 16 million by 2050. Utah, with more than 22,000 Alzheimer's cases, is expected to top 50,000 by 2025.
Flurizan continues to lead the Alzheimer's drug development sector as a "selective amyloid beta 42 lowering agent." It is a new class of drug that targets the toxic peptide believed to form plaque that clogs neural pathways in the Alzheimer's patient's brain, damaging neurons and triggering senility.
Competing candidate treatments for the disease are close behind the Salt Lake City biopharmaceutical company. One is Quebec's Neurochem Inc., which has enrolled about 1,000 patients in its late-stage human test in Canada and the United States. It's also recruiting a similar number for a European trial. Neurochem hopes to complete the trial by January, perhaps a few months ahead of Myriad.
"If everything goes well, we could have approval in 2008," Neurochem spokeswoman Lise Hebert told The Associated Press.
Also in the chase is Ireland's Elan Pharmaceuticals, which is testing its drug in about 180 patients.
Investors Monday gave Myriad a nod of approval, boosting share prices to $27.16, up 77 cents, or 3 percent.
bmims@sltrib.com
About Flurizan
Myriad Genetics is gambling millions in research and development funding that Flurizan's promise against Alzheimer's disease holds true.
Testing thus far shows Flurizan effective in halting the progress of Alzheimer's for nearly two years, and counting.
Enrollment is under way for what is believed to be the largest Alzheimer's drug test ever: 1,600 patients.
At stake is a potentially large stake in the $4 billion Alzheimer's drug market.
