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Myriad Tests Alzheimer's Drug

Posted on: Wednesday, 22 June 2005, 00:00 CDT

Jun. 21--Promising test results for a leading Alzheimer's drug offers both hope for the disease's millions of sufferers and a potential multibillion-dollar market for developer Myriad Genetics Inc.

On Monday, the Salt Lake City bio-pharmaceutical company detailed its recently completed, yearlong Phase 2 trial of Flurizan. Researchers said their findings confirm the drug as a potential breakthrough in Alzheimer's treatment, especially in its early stages.

"These results are quite remarkable, and it's important to note that none of the drugs on the market today do anything to slow actual progression of the disease," Myriad CEO Peter Meldrum said. "[Other drugs] just provide temporary, symptomatic relief."

The study found that patients with mild Alzheimer's who were given twice-daily, 800 milligram doses saw 34 to 45 percent slowing in decline of their mental faculties.

Gordon Wilcock, the University of Bristol-based principal investigator for study, characterized it as "the most successful" trial of its kind so far. "It is very encouraging for its potential to address a very large and growing worldwide population of patients with mild Alzheimer's disease," he said.

With a final Phase 3 trial already under way, Myriad hopes to gain Food and Drug Administration approval and begin marketing Flurizan as soon as 2008.

The Phase 2 results, from 207 patients spread over 30 test sites in Canada and the United Kingdom, were released Monday at the Alzheimer's Association's International Conference on Prevention of Dementia in Washington, D.C.

"We are very excited to see there are drugs in the pipeline moving from the current symptomatic treatments to drugs which may address the progress of the disease," association spokesman Niles Frantz said. "Whether it ends up being [Flurizan] or another compound remains to be seen."

Myriad's candidate, while closer to possible FDA approval than any other, is not alone in a new generation of Alzheimer's drugs focusing on the toxic beta amyloid 42 protein blamed for brain plaque that deteriorates cognition and memory.

For now, Flurizan is out front as a "selective amyloid beta 42 lowering agent" -- 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.

While Flurizan specifically targets gamma secretase, an enzyme associated with mutation of normal beta amyloid, Baxter International hopes to attack the plaque through a yet-to-be-developed antibody. Meanwhile, the University of Washington School of Medicine is testing inhaled insulin as a possible remedy.

Researchers found Flurizan's benefit was most dramatic for the group's 128 mild Alzheimer's sufferers, who experienced slower degeneration in daily activities and cognitive abilities such as word recall, response to directions, quality of speech and copying geometric forms.

However, the drug also showed notable improvement for moderate-level patients in relieving the agitation, paranoia and anxiety often experienced by Alzheimer's patients.

Myriad already is six months into Phase 3 trials that will involve 1,600 patients, split into Flurizan and placebo groups. Results are expected in two years, Meldrum said, and the drug could be on the market in three.

What is Flurizan? A potential breakthrough treatment attacking the cause of Alzheimer's, a toxic brain sludge that steadily destroys patients' cognitive abilities.

What do most recent tests show? A 34 to 45 percent slowing in the decline of mental faculties by mild Alzheimer's sufferers taking 800 milligram doses of Flurizan twice daily.

When could it come to market? Three years, if the Food and Drug Administration approves the drug quickly once the final phase of testing is completed.

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Copyright (c) 2005, The Salt Lake Tribune

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MYGN,

Source: The Salt Lake Tribune

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