Favrille Announces Positive Results From Specifid Trial
Favrille announced results from Phase 3 registration trial of Specifid following Rituxan in patients with follicular B-cell non-Hodgkin's lymphoma (NHL).
Analysis of time to progression (TTP), the primary endpoint in the trial, failed to show a statistically significant improvement in the treatment arm, Specifid plus Leukine (sargramostim, GM-CSF) following Rituxan, compared to the control arm, placebo plus Leukine following Rituxan. Analysis of all subgroups also did not show any significant differences in primary or secondary endpoints when adjusted for prognostic factors.
The safety profile was comparable between the two arms and consistent with what has been observed in previous Specifid trials. Most adverse events reported in the trial were of low grade.
"We are clearly very disappointed with the data from this trial, particularly on behalf of the patients and their families," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "Based on these results, we are discontinuing development of Specifid and are currently evaluating steps to conserve cash and recognize value on our assets. We wish to thank all of our employees and the patients, clinical investigators and trial coordinators for their support and dedication."
About the Phase 3 Registration Trial
Favrille initiated its Phase 3 randomized, placebo-controlled, double-blind registration trial of Specifid for follicular B-cell NHL in July 2004. The Company completed enrollment in January 2006 with 349 patients randomized into the trial. The trial was open to both treatment-naive and previously treated patients, ultimately enrolling a much larger treatment-naive population (78%). Patients were randomized at a one-to-one ratio to receive either Specifid or placebo following a standard course of Rituxan. The trial was conducted at 67 centers in the U.S.