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Stimuvax(R) Phase III clinical trial in patients with non-small cell lung cancer now open for patient enrollment
Stimuvax(R) Phase III clinical trial in patients with non-small cell lung cancer now open for patient enrollment.
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[{"type":"text","content":"\n\n\n\nEDMONTON, Jan. 2 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) today\nannounced that the global Phase III clinical trial, START (Stimulating\nTargeted Antigenic Responses To NSCLC), assessing the efficacy and safety of\nStimuvax(R) (BLP25 liposome vaccine) as a potential treatment for patients\nwith unresectable stage III non-small cell lung cancer (NSCLC) is open for\npatient enrollment. The trial is being conducted by Merck KGaA of Darmstadt,\nGermany, (\"Merck\") and its U.S. affiliate EMD Pharmaceuticals, Inc. under the\nprovision of a collaboration agreement between Biomira and Merck. Biomira is\nentitled to a milestone payment upon enrollment of the first patient in the\nPhase III trial, which is anticipated to occur in January 2007.\n\n\nEnrollment in the trial, which is expected to include more than 1,300\npatients in approximately 30 countries, is now open to patients in 12\ncountries, including the U.S., and will subsequently expand to additional\ncountries. Currently, there are no approved maintenance therapies for patients\nresponding to first-line treatment for unresectable stage III NSCLC.\n\n\nAbout the START Trial\n\n\nThe START trial is a randomized, double-blind, placebo-controlled study\nthat will evaluate patients with documented unresectable stage III NSCLC who\nhave had a response or stable disease after at least two cycles of platinum\nbased radio-chemotherapy. The study has been designed considering scientific\nadvice from the European Medicines Agency (EMEA/CHMP) and has been agreed upon\nwith the U.S. Food and Drug Administration (FDA) through a Special Protocol\nAssessment (SPA). Data from a randomized phase IIb trial described below\nencouraged the initiation of the Phase III program.\n\n\nFor more information on the START trial, or to find a participating\ncenter and eligibility criteria, log on to www.StimuvaxSTART.com or\nwww.clinicaltrials.gov.\n\n\nAbout Stimuvax\n\n\nStimuvax is an innovative cancer vaccine designed to induce an immune\nresponse to cancer cells that express MUC1, a protein antigen widely expressed\non common cancers. MUC1 is over expressed on many cancers such as lung cancer,\nbreast cancer and colorectal cancer. Stimuvax is thought to work by\nstimulating the body's immune system to identify and destroy cancer cells\nexpressing MUC1.\n\n\nA randomized Phase IIb trial w...