Phase 3 Clinical Trial Summary
We initiated our Phase 3 randomized, placebo-controlled, double-blind registration trial of Specifid™ following Rituxan® in patients with follicular B-cell non-Hodgkin’s lymphoma (NHL) in July 2004. We completed enrollment in January 2006 with 349 patients randomized into the trial. The trial was open to both treatment-naïve and previously treated patients. 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.
On May 27, 2008, we announced that 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.
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.