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Article: Seeking Confirmation, Nabi Starts StaphVAX Phase III Renal Study.(Nabi Biopharmaceuticals Inc.)
- Article from:
- BIOWORLD Today
- Article date:
- September 30, 2003
- Author:
CopyrightCOPYRIGHT 2003 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Byline: Randall Osborne, National Editor
Using lessons learned from the first Phase III trial of StaphVAX, Nabi Biopharmaceuticals Inc. started the second Phase III study - intended to be pivotal - with the vaccine designed to block Staphylococcus aureus in end-stage renal disease patients.
"We should have results mid-2005 and be able to file our biologics license application by the end of 2005," said Mark Soufleris, vice president of investor and public relations for Rockville, Md.-based Nabi.
About 3,000 patients on hemodialysis will be enrolled at about 200 sites in the U.S., using the peak efficacy point of the first trial - eight months - ...