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www.fdanews.com/articles/89623-myriad-s-prostate-cancer-trial-does-not-meet-endpoints

MYRIAD'S PROSTATE CANCER TRIAL DOES NOT MEET ENDPOINTS

January 8, 2007

Myriad Genetics has announced the results of its multicenter, double-blind, placebo-controlled trial of MPC-7869 (R-flurbiprofen) in prostate cancer. The clinical trial was designed to evaluate the safety of MPC-7869 and to consider its potential efficacy in slowing the rate of progression of prostate cancer among 246 patients with advanced disease.

Patients participating in the study were assigned to one of three arms (800 mg of MPC-7869 once daily or twice daily or placebo). The two primary clinical endpoints of the trial were the time to systemic disease progression and the change in velocity of prostate-specific antigen levels. Statistical significance was not achieved for either of the endpoints, and therefore the company does not intend to pursue further development of this compound in cancer. Myriad said it will continue to concentrate its efforts on the compound's demonstrated activity in Alzheimer's disease.

The study showed that MPC-7869 was well tolerated over long-term administration in an elderly population, confirming the data from previous studies. With the completion of this study, Myriad now has more than 1,200 patient-years of safety data on this compound, with a maximum exposure period of 44 months.

The study showed no significant differences in adverse events between the placebo and drug-treated arms. Additionally, during the course of the study, there were no significant differences in serious adverse events between the drug and placebo arms.

"The safety data collected in this trial will be very useful to our program in Alzheimer's disease," Peter Meldrum, president of Myriad, said. "The age of the study population is similar, and the 800-mg twice-daily dose of MPC-7869 is identical to that of our two ongoing Phase III trials in Alzheimer's disease."