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Biomira announces final Phase 2b survival results of Stimuvax(R) (formerly known as BLP25 Liposome Vaccine) trial in patients with non-small cell lung cancer
Biomira announces final Phase 2b survival results of Stimuvax(R) (formerly known as BLP25 Liposome Vaccine) trial in patients with non-small cell lung cancer.
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[{"type":"text","content":"\n\n\n\n\nResults confirm median survival of 30.6 months in stage IIIB patients on \nvaccine versus 13.3 months in control patients\n\nEDMONTON, April 28 /CNW/ - Biomira Inc. (Nasdaq:BIOM) (TSX:BRA) today\nannounced final survival results from an exploratory analysis of the Phase 2b\nclinical trial data. The randomized, open-label trial tested the clinical\npotential of Stimuvax(R) in patients with Stage IIIB and IV non-small cell\nlung cancer (NSCLC). The analysis confirms a median survival in Stage IIIB\npatients on vaccine being 30.6 months, while Stage IIIB patients on the\ncontrol had a median survival of 13.3 months.\n\"Our enthusiasm around Stimuvax(R) continues,\" said Alex McPherson, MD,\nPhD, President and CEO of Biomira. \"These data from the Phase 2b trial are\nencouraging and have been reviewed by an independent statistician, who\nconfirms our findings. We are in the process of completing the transition of\nthis exciting project to Merck KGaA of Darmstadt, Germany and we have begun\nmanufacturing the vaccine required for the phase 3 study slated to start this\nsummer. We are hopeful that this larger randomized trial will confirm the\nresults seen in the phase 2b trial.\"\n\nStimuvax(R): Clinical Study Design and Results of Additional Analysis\nThe controlled, open-label Phase 2b trial enrolled 171 men and women with\nNSCLC whose disease was stable or who had responded to treatment following\ncompletion of their first-line standard chemotherapy with or without radiation\ntherapy. Patients were randomized to either Stimuvax(R) plus best supportive\ncare or to best supportive care alone. Best supportive care includes\npalliative radiation therapy and/or second line chemotherapy according to\ncurrent standard clinical practice. The study was designed to document the\nsafety profile of the vaccine and to evaluate efficacy by comparing survival\nin the two arms.\nAn earlier survival analysis reported in November 2004, indicated that\nthe median survival in the pre-stratified subset of locoregional Stage IIIB\npatients on the vaccine arm had not been reached. Informal survival results\nfrom an additional exploratory analysis have now been confirmed showing a\nmedian survival in the Stage IIIB patients on vaccine being 30.6 months, while\nthe Stage IIIB patients on the control had a median survival of 13.3 months.\n\nStimuv...