Clinical Trial Research
Spectrum Expands Clinical Trials Into Canada; Directorate of Health Canada Accepts Spectrum Pharmaceuticals Clinical Trial Application for Ozarelix in BPH
Published in Medical Letter on the CDC and FDA, May 20th, 2007
Spectrum Pharmaceuticals, Inc., (NASDAQ:SPPI) announced that the Therapeutic Product Directorate of Health Canada has issued a No Objection Letter to Spectrum's Clinical Trial Application. This action authorizes the initiation of investigational clinical trials for ozarelix in Benign Prostate Hypertrophy (BPH), as part of a multinational development program in this indication. Advancement into pivotal registration trials is anticipated in late 2007.
"We expect to begin Phase 3 testing with ozarelix in patients with BPH later this year, and the opportunity to conduct trials with ozarelix at select sites in both Canada and the U.S. will enable us to enroll and begin...
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