Nabi says to continue Gram-positive program after panel review

By Lisa Kerner

Erie, Pa., March 21 - Nabi Biopharmaceuticals said it will continue development of its Gram-positive program, led by StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine) and Altastaph ((Staphylococcus aureus Immune Globulin Intravenous (Human)).

The company based its decision on an outside advisory panel's review of the company's assessment of the StaphVAX confirmatory phase 3 clinical study results.

The assessment revealed marked differences in the effectiveness of the lot of vaccine used in this study compared to the lot used in the previous phase 3 clinical study, according to a company news release.

Because these results were not consistent with previous positive clinical data for StaphVAX, the company formed the outside advisory panel to determine what led to the unexpected results.

According to the release, the panel was to review and revise the plan; analyze the data; and provide direction for the future development of the company's Gram-positive infections program.

Nabi and the panel concluded that the antibodies generated by the vaccine in the confirmatory clinical study were inferior to those generated by vaccine lots used in previous and subsequent studies.

The company, along with the panel, also concluded that medical factors associated with kidney disease in dialysis patients impaired their immune response to the vaccine, resulting in a lack of protection in that particular study population.

"Today's announcement marks a new beginning for our Gram-positive program, which is much enhanced by the knowledge we've gained about the bacteria and immune response," chairman, chief executive officer and president Thomas H. McLain said in the release.

"Moving forward, we have a clear development pathway on which to readily advance our vaccine and antibody products toward commercialization."

Nabi leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company is located in Boca Raton, Fla.

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