NovaRx Moves into Phase III with Cancer Vaccine Lucanix

Hoping to repeat its Phase II success, privately held NovaRx Corp. launched a pivotal study of therapeutic vaccine Lucanix (belagenpumatucel-L) in non-small-cell lung cancer (NSCLC) patients under a special protocol assessment approved early this year. Designated as STOP for its expected endpoints - survival, tumor-free survival, overall survival and progression-free survival - the trial is expected to enroll up to 700 patients with advanced-stage disease who have been treated with at least one prior platinum-based chemotherapy regimen. Patients will be randomized to receive Lucanix or placebo, administered intradermally, once-monthly for 18 months and then once at 21 months and at 24 months. Overall survival is the primary endpoint, while secondary endpoints will include progression-free survival, tumor response and quality... [read full story]