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Biomira and Merck KGaA commence BLP25 Liposome Vaccine Phase II safety study
Biomira and Merck KGaA commence BLP25 Liposome Vaccine Phase II safety study.
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[{"type":"text","content":"\n\n\n\n\nEDMONTON and DARMSTADT, Germany, April 20 /CNW/ - Biomira Inc.\n(Nasdaq: BIOM) (TSX: BRA) and Merck KGaA of Darmstadt, Germany, today\nannounced the start of a Phase II, single-arm, multi-centre, open label study\nof BLP25 Liposome Vaccine (L-BLP25).\nThe trial will assess the safety of the formulation of L-BLP25 that the\nCompanies expect to use in the upcoming Phase III study. This formulation\nincorporates manufacturing changes intended to secure the future commercial\nsupply of the vaccine. Enrolment of the 20-patient trial involving men and\nwomen with non-small cell lung cancer (NSCLC) from eight clinical trial sites\nin Canada is expected to be completed in the third quarter of 2005, with\ninitial results anticipated before the end of 2005.\nData obtained in 2004 from the NSCLC Phase IIb trial showed the greatest\nsurvival advantage in vaccinated patients with Stage IIIB locoregional (LR)\ndisease. The new Phase II trial will include patients with unresectable\nStage III disease. Thus, Stage IIIB LR patients will be included as well as,\nfor the first time, patients with Stage IIIA disease. All patients in the\nPhase II trial must have demonstrated either stable disease or a clinical\nresponse after primary therapy of combined modality treatment (chemotherapy\nand radiation therapy). These same criteria are to be used for the planned\nPhase III trial.\n\"The start of this Phase II trial is another step toward commencing our\nlarge, multi-national Phase III study, which we hope to begin by the end of\nthis year,\" said Alex McPherson, MD, PhD, President and CEO. \"If appropriate\ndata from this Phase II trial are obtained, they may be used in discussions\nwith Canadian regulatory authorities concerning the potential for early\napproval of this product candidate.\"\nDiscussions over recent months with Health Canada indicate that safety\ndata from this Phase II study will be needed before Health Canada will\nconsider whether the product might be eligible for early approval based on\nsurvival data from the earlier Phase IIb study. The Companies, given recent\nfeedback obtained from the US FDA, will not pursue early approval in the US.\nNonetheless, the Companies are encouraged by the helpful comments from the US\nFDA regarding our clinical registration plans.\n\nAbout Lung Cancer\nIn 2004, approximately 174,000 new ...