Alzheimer’s Disease :: Myriad Genetics’ Flurizan benefits Alzheimer’s patients

Myriad Genetics, Inc. (NASDAQ: MYGN) announced that it presented additional results of its completed Phase 2 follow-on study of Flurizan? in patients with mild Alzheimer’s disease at the annual meeting of the American Association for Geriatric Psychiatry (AAGP), held March 1-4, 2007 in New Orleans.

The data indicate that Flurizan may be capable, not only of slowing the decline of Alzheimer’s disease, but of halting the disease in its tracks. In this study, many patients with Alzheimer’s disease got no worse over two full years, and in some cases, patients treated with Flurizan appear to have improved.

At 24 months, study participants in the Phase 2 trial with mild Alzheimer’s disease taking 800 mg twice daily Flurizan experienced a 67% improvement in their level of cognitive decline compared with placebo, as measured by the Mini Mental State Exam (MMSE) score. This difference was highly significant statistically (p=0.001). Additionally, based upon the MMSE score, three times the percentage of patients on Flurizan demonstrated improvement in cognition or zero decline, compared to patients on placebo: Forty-two percent of patients on 800 mg twice daily Flurizan experienced improvement or zero decline, compared with 14% of patients taking placebo. MMSE is the primary test used by most clinicians to help diagnose, assess and monitor progression of patients with Alzheimer’s disease. It was also the principal criterion for selecting patients to enroll in the Phase 2 study, and is a secondary endpoint in the two ongoing Phase 3 trials of Flurizan.

Overall, 42% of patients on Flurizan showed improvement or no decline in one or more of the three primary endpoints of cognition, global function and activities of daily living, compared to 10% of patients on placebo. On the test that measures cognition, ADAS-cog, 25% of study participants taking 800 mg BID of Flurizan showed cognitive improvement or experienced zero decline in cognition after 24 months, compared with none on placebo. With the CDR-sb test, a measure of overall function in Alzheimer’s patients, 29% of study participants on Flurizan experienced an improved or zero decline score, compared with none of those on placebo.

Robert C. Green, M.D., MPH, Co-Director, Alzheimer’s Disease Clinical & Research Program, Professor of Neurology, Genetics and Epidemiology at the Boston University School of Medicine, and a lead investigator on the Phase 3 trial of Flurizan, commented, “This analysis of patient response to Flurizan in the Phase 2 trial suggests that the drug may, in many patients, actually halt disease progression over a 24-month time frame. Since Flurizan appears to slow the biological progression of the disease, this is an exciting and novel finding, and if replicated in the ongoing Phase 3 trials will be extraordinarily important.”

To recap the efficacy results of the Phase 2 study at month 24 presented earlier, mild patients taking 800 mg of Flurizan twice daily had an effect size of 72%, with a statistically significant value of p=0.0005, as measured by their global function on the CDR-sb test. In activities of daily living, the patients showed a statistically significant 67% effect size (p=0.015). Cognition improvement showed an effect size of 52% at 24 months on the ADAS-cog scale. These data suggest that there is a substantial benefit from Flurizan.

The additional data presented at the AAGP meeting and announced today add detail to these effect sizes by demonstrating that, not only did the population as a whole respond to the treatment, but a meaningful portion of the patients who responded to the treatment did so by experiencing either zero decline after two years or a reversal of their decline to actual improvement, something that is very rare in Alzheimer’s disease. Comparisons to placebo at 24 months refer to the placebo group as originally randomized.

The vast majority of patients in this Phase 2 study, approximately 94% at the time of enrollment, were receiving stable doses of acetylcholinesterase inhibitors, which are FDA-approved drugs for symptomatic treatment of Alzheimer’s disease. Thus, the benefits of Flurizan observed in these patients were over and above the current standard of care.

“The 24 month Phase 2 responder analysis provides further evidence of efficacy against mild Alzheimer’s disease that is consistent with our understanding of Flurizan’s mechanism of action as a SALA,” said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. “The results support our belief that Flurizan is modifying the course of the underlying disease process.”

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