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Nabi halts development on StaphVAX after it fails phase III trial
By E. Janene Geiss
Philadelphia, Nov. 1 - Nabi Biopharmaceuticals announced Tuesday that StaphVAX failed to meet its primary endpoint in the company's phase III clinical trial.
The randomized, double-blinded, placebo-controlled trial of 3,600 patients on hemodialysis found no reduction in the S. aureus types 5 and 8 infections in the StaphVAX group as compared to the placebo group.
"We are obviously surprised and very disappointed with the results of the StaphVAX confirmatory Phase III trial," Thomas H. McLain, chairman, president and chief executive officer, said in a news release.
The company said 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. Results will be available in the next few months.
"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," McLain said.
The company said StaphVAX was highly immunogenic, confirming that Nabi's vaccine conjugation technology is effective in producing and sustaining high levels of specific antibodies.
Nabi said it will halt further development of StaphVAX and withdraw its Marketing Authorization Application to market StaphVAX in the European Union, officials said. It will also halt development of Altastaph, its investigational product for the prevention and treatment of S. aureus infections because it was based on the same capsular polysaccharide technology as StaphVAX.
The company said it still plans to advance development of other vaccine programs, including NicVAX for smoking cessation and Civacir for prevention of hepatitis C post-liver transplant.
Nabi, based in Boca Raton, Fla., is a biopharmaceutical company focused on powering the immune system to fight serious medical conditions.
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