Business
Biomira announces change to timetable for BLP25 Liposome Vaccine phase 3 trial
Biomira announces change to timetable for BLP25 Liposome Vaccine phase 3 trial.
About this update from Skrr Exploration, Inc.
[{"type":"text","content":"\n\n\n\n\nEDMONTON, Sept. 23 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) today\nannounced a change to the anticipated timetable for the start of its planned\nBLP25 Liposome Vaccine (L-BLP25) phase 3 study in the treatment of non-small\ncell lung cancer (NSCLC). The change will allow the Company and its\ncollaborator on L-BLP25, Merck KGaA of Darmstadt, Germany, to address an\naccelerated stability issue discovered during the manufacturing process.\nAs a result, the start of the trial, which was planned to start at the\nend of 2005, is now expected to move into 2006.\nAn accelerated stability study of a vaccine lot manufactured to test\nphase 3 manufacturing processes and equipment indicated a stability problem,\nwhich may have been due to excess moisture in the product. Accelerated\nstability studies are intended to provide data to predict long-term product\nstability under normal storage conditions. The Companies, working with the\ncontract manufacturer, are focused on resolving this issue as quickly as\npossible.\n\"An article published in the prestigious Journal of Clinical Oncology\n(JCO) this month underlined our confidence in the potential of L-BLP25 and the\nclinically important results seen with the product to date in the treatment of\nnon-small cell lung cancer,\" said Dr. Alex McPherson, MD, PhD, President and\nCEO of Biomira. \"We are working with Merck KGaA and others to discover the\ncause of the problem now evident during the manufacturing process and to take\ncorrective action as quickly as possible.\"\n\nAbout Lung Cancer\nIn 2004, approximately 174,000 new cases of lung cancer were diagnosed in\nthe U.S. Approximately 160,000 people are estimated to have died of this\ndisease in the U.S. alone in 2004. NSCLC accounts for approximately 75 to \n80 per cent of all primary lung cancers. At the time of diagnosis, only \n25 per cent of patients are potentially curable by surgery.\n\nThe Companies\nBiomira's collaboration in developing therapeutic cancer vaccines is with\nMerck KGaA. Merck is a global pharmaceutical and chemical company with sales\nof EUR 5.9 billion in 2004, a history that began in 1668, and a future shaped\nby 28,600 employees in 54 countries. Its success is characterized by\ninnovations from entrepreneurial employees. Merck's operating activities come\nunder the umbrella of Merck KGaA, in which t...