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news.In a confirmatory phase III trial, Nabi Biopharmaceuticals investigational vaccine Staphvax failed to meet its primary endpoint of prevention of S aureus infection in kidney disease patients.
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The study of 3,600 patients on hemodialysis, found no reduction in S aureus types 5 and 8 infections in the Staphvax group as compared to the placebo group.
The company says that it will immediately initiate an assessment to determine the factors causing this outcome, including the vaccine target and the quality of the antibody generated by the vaccine.
Staphvax was however highly immunogenic in the trial, confirming that the company’s vaccine conjugation technology is effective in producing and sustaining high levels of specific antibodies.
While the company completes its assessment of the phase III trial results, it will halt further development of Staphvax and will withdraw its marketing authorization application (MAA) to market Staphvax in the European Union.
The company will also halt the development of Altastaph, another investigational product for the prevention and treatment of S aureus infections, as it is based on the same capsular polysaccharide technology as Staphvax.
The significant majority of the company’s development spending in 2005 has been directed toward pre-launch and clinical activities for Staphvax and Altastaph. Spending on these activities will stop during the fourth quarter of 2005.
The company now expects shift its focus to the development of its other vaccine programs, including Nicvax which is currently in phase IIb clinical trials being developed to treat nicotine addiction and prevent smoking relapse; and its antibody product Civacir for the prevention of hepatitis C after liver transplant.
“We are obviously surprised and very disappointed with the results of the Staphvax confirmatory phase III trial,” said Thomas McLain, chairman, president and CEO. “While we complete our assessment over the next few months, we will re-focus our capabilities in developing vaccine and antibody products in other areas of significant medical need.”