DMC'S ANALYSIS SHOWS FAVRILLE'S NHL TRIAL MISSES SECONDARY ENDPOINT

Favrille announced that a data monitoring committee (DMC) completed its prospectively planned interim analysis of a secondary endpoint in the first 233 patients enrolled in the company's ongoing randomized, double-blind, placebo-controlled, Phase III clinical trial of FavId following Rituxan induction therapy in patients with follicular B-cell non-Hodgkin's lymphoma (NHL).

The interim analysis showed a high percentage of patients converted to complete remission over time. The objective response rate (ORR) was first assessed eight weeks following Rituxan induction treatment, at which time it was 64 percent, with 18 percent of patients in complete remission. The best response rate was assessed at three-month intervals, and ORR was shown to increase to 70 percent, with 46 percent of patients in complete remission. Treatment with FavId or placebo was initiated after the first response assessment. The blinded data showed that 41 percent of patients who were assessed as stable disease or partial remission at the end of Rituxan induction treatment had a response improvement, and 80 percent of those patients converted from partial to complete remission.

The DMC indicated that this prospectively planned interim analysis did not demonstrate a statistically significant difference between treatment and control groups in the secondary endpoint of response improvement. The primary endpoint in the trial is time to disease progression (TTP).

"The most clinically important observation from this interim analysis was that nearly 50 percent of patients in this trial achieved complete remission over time," John Longenecker, president and CEO of Favrille, said. "This means that we are now following a large set of patients who have converted to complete remission. Although we did not see statistical difference in overall response improvement between the two arms, indicating more late responses to the control arm than we had expected, it is important to remember that the unmet medical need in the treatment of indolent B-cell NHL is the durability of a response. This analysis shows we will have a large number of patients in both partial and complete remission to follow for our primary endpoint of TTP."