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BLP25 Liposome Vaccine phase 2 study interim results indicate no safety concerns with reformulated vaccine
BLP25 Liposome Vaccine phase 2 study interim results indicate no safety concerns with reformulated vaccine.
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[{"type":"text","content":"\n\n\n\n\nEDMONTON, Nov. 17 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) today\nannounced the interim results of a phase 2 non-small cell lung cancer (NSCLC)\nsingle-arm, multi-centre, open label study of BLP25 Liposome Vaccine (L-BLP25)\nshowing that the new formulation of the vaccine is not different from the\nprevious formulation from a safety perspective. The reformulated vaccine\nincorporated manufacturing changes intended to secure the future commercial\nsupply of the vaccine.\nThough not a head-to-head comparison, the phase 2 trial compared the new\nformulation of L-BLP25 to the formulation used in the phase 2b trial, which\nwas completed in 2004. A comparison of baseline and post-four vaccination\nlaboratory tests for each trial, and between trials was conducted. For the\nmajority of patients in both trials, the laboratory results were within the\nnormal range for both time points. Also examined, for the same time frame,\nwere adverse events, and injection site reactions. Although the two trials\nhave slightly different patient populations and different sample sizes, based\non the information reviewed, there is no clinical rationale to indicate that\nthe two vaccine formulations are different from a safety perspective. The new\nformulation incorporated manufacturing changes intended to secure the future\ncommercial supply of the vaccine.\nIn October, Biomira and Merck KGaA of Darmstadt, Germany announced that\nfollow-up of patients enrolled in the phase 2b trial had determined a median\nsurvival for the vaccinated subset of Stage IIIB locoregional patients of 30.6\nmonths compared to 13.3 months observed for the same stage patients who did\nnot receive the vaccine, a difference of 17.3 months.\nTests to resolve a contract manufacturing stability issue are ongoing,\nwith results expected in the first quarter of 2006.\n\nThe Companies\n\nBiomira is a biotechnology company specializing in the development of\ninnovative therapeutic approaches to cancer management. Biomira's commitment\nto the treatment of cancer currently focuses on the development of synthetic\nvaccines and novel strategies for cancer immunotherapy. We are The Cancer\nVaccine People(TM).\nMerck is a global pharmaceutical and chemical company with sales of\nEUR 5.9 billion in 2004, a history that began in 1668, and a future shaped by\n28,600 employees in 5...