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Biomira receives special protocol assessment from the FDA for Phase III trial of Stimuvax for non-small cell lung cancer
Biomira receives special protocol assessment from the FDA for Phase III trial of Stimuvax for non-small cell lung cancer.
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[{"type":"text","content":"\n\n\n\nEDMONTON, Dec. 12 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) today\nannounced that it has reached an agreement with the U.S. Food and Drug\nAdministration on a Special Protocol Assessment (SPA) for the planned Phase\nIII clinical trial of Stimuvax(R) for the treatment of non-small cell lung\ncancer (NSCLC). The SPA agreement between Biomira and the FDA concerns the\ndesign of the Phase III trial and outlines definitive clinical objectives and\ndata analyses considered necessary to support regulatory approval of Stimuvax.\nThe trial will be conducted by Merck KGaA under terms of a licensing\narrangement with Biomira.\n\n\nThe planned Phase III trial is a multi-center, randomized, double-blind\nplacebo controlled trial of Stimuvax in patients with unresectable Stage III\nnon-small cell lung cancer. The trial is expected to enroll approximately\n1,300 patients in over 250 centers in approximately 30 countries. The primary\nendpoint of the trial is overall survival in patients receiving Stimuvax\ncompared to those receiving placebo.\n\n\n\"This trial builds upon the encouraging results seen in Biomira's Phase\nIIb trial of Stimuvax in patients with stage IIIB and IV non-small cell lung\ncancer,\" said Robert L. Kirkman, M.D., President and CEO of Biomira. \"In that\ntrial, the median survival in the subset of patients with locoregional Stage\nIIIB disease was 30.6 months for patients receiving Stimuvax, compared with\n13.3 months for patients in the control arm. The Phase 3 trial will seek to\nextend and confirm these results in patients with both Stage IIIA and IIIB\nlocoregional disease.\"\n\n\n\"Completion of the SPA agreement with the FDA is an important step in the\nclinical development of Stimuvax,\" continued Dr. Kirkman. \"We look forward to\nthe initiation of this Phase III trial by the end of this year.\"\n\n\nStimuvax(R)\n\n\nFormerly known as BLP25 Liposome Vaccine (L-BLP25), Stimuvax(R) is a\nsynthetic MUC1 peptide vaccine. Stimuvax(R) incorporates a 25-amino acid\nsequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery\nsystem. The liposome enhances recognition of the cancer antigen by the immune\nsystem and facilitates better delivery. Stimuvax(R) is designed to induce an\nimmune response to cancer cells.\n\n\nAbout Lung Cancer\n\n\nIn 2005, approximately 172,000 new cases of lung cancer we...