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Article: NABI SEES POSITIVE RESULTS IN PHASE III OF STAPHVAX.
- Article from:
- BIOWORLD Today
- Article date:
- August 26, 1999
- Author:
CopyrightCOPYRIGHT 1999 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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Interim results from a pivotal trial testingthe ability of the Nabi-StaphVAX vaccine toprevent gram-positive bacterial infections inhigh-risk patients showed the product is ontrack to have a statistically significant endresult that can be used to file a new drugapplication with the FDA.
Nabi, of Boca Raton, Fla., is testing a singledose of Nabi-StaphVAX in a Phase III trialagainst a placebo injection in 1,800 end-stagerenal disease patients who are dependent ondialysis. An outside data safety andmonitoring board that conducted the analysisdetermined the study would support a filingshould the current data trends continue.
"We are very happy about the ...