Nabi continues StaphVAX despite confusing Ph III data

The USA's Nabi Biopharmaceuticals will continue development of its Gram-positive program, led by StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) and Altastaph (Staphylococcus aureus immune globulin intravenous human), despite a recent Phase III clinical study which missed its primary endpoints showing marked differences in effectiveness compared to a previous Phase III clinical study.

Nabi's decision was based on conclusions from an outside advisory panel's review of its assessment of the failed StaphVAX study, which it formed becase the results were not consistent with previous positive clinical data. With the panel's advice, Nabis has concluded that the functional characteristics of the antibodies generated by the vaccine were inferior to antibodies generated by lots used in previous and subsequent studies. Furthermore, Nabi stated that medical factors associated with kidney disease in dialysis patients impaired their immune response to the vaccine. Considered in combination with an increase in the virulence of the bacteria, the firm says these factors also contributed to the observed lack of protection in this study population.