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Non-Tech : Nabi (NABI)
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To: kenhott who wrote (342)3/21/2006 6:51:19 PM
From: kenhott   of 354
 
Little more details from PR:

The quality or functional characteristics of the antibodies generated by the vaccine used in the confirmatory clinical study was inferior to those antibodies generated by vaccine lots used in previous and subsequent clinical studies.

...cut...

As background, the first Phase III clinical study used a vaccine produced at small scale in Nabi Biopharmaceuticals' own research and development pilot manufacturing facility. The confirmatory Phase III study used a vaccine produced at large scale by a contract manufacturer. Subsequent bridging and immunogenicity clinical studies completed in 2005 used vaccine lots produced by a second contract manufacturer, Cambrex Bio Science Baltimore, Inc. (Cambrex). Nabi Biopharmaceuticals moved production to Cambrex because their facility was configured to be licensable for Europe.

The results of a series of experiments have demonstrated that the quality of the antibodies generated by the vaccine used in the confirmatory Phase III study was inferior to the antibodies generated by the vaccine manufactured by Nabi Biopharmaceuticals used in the first Phase III clinical study. This assessment was based on data from functional antibody assays and confirmed through a series of animal protection model studies. As an example, healthy animals dosed with the vaccines or with human antibodies generated from vaccines manufactured by Nabi Biopharmaceuticals were 100 percent protected from challenge against Type 8 S. aureus bacteria. In contrast, only 30 to 50 percent of the animals dosed with the vaccine or human antibodies from the lot used in the confirmatory Phase III study were protected against subsequent challenge with Type 8 S. aureus bacteria.

Also of significance, Nabi Biopharmaceuticals further substantiated this outcome through experiments using lots of vaccine produced by the second contract manufacturer, Cambrex. A series of clinical immunogenicity studies in dialysis and surgical patients, as well as healthy adults dosed with Cambrex-manufactured StaphVAX, were completed in 2005. Experiments using antibodies from patients in these studies demonstrated a protection benefit that was similar to the vaccine produced by Nabi Biopharmaceuticals. Animals dosed with these antibodies were 100 percent protected from challenge with the bacteria.

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lol. Another example why clinic trials are a little like running on thin ice.
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