You are here
No Reduction in <i>S. aureus</i> Infections Observed in StaphVAX Study
The study, a randomized, double-blinded, placebo-controlled trial 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 will immediately initiate an assessment to determine the factors causing this outcome, including the vaccine target (S. aureus polysaccharide capsule) and the quality of the antibody generated by the vaccine. Results will be available within the next few months. It is important to note, however, that StaphVAX was highly immunogenic, confirming that Nabi Biopharmaceuticals' vaccine conjugation technology is effective in producing and sustaining high levels of specific antibodies.
Thomas H. McLain, chairman, president and chief executive officer, Nabi Biopharmaceuticals, stated, "We are obviously surprised and very disappointed with the results of the StaphVAX confirmatory Phase III trial. 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. This includes advancing other bacterial vaccines in development; NicVAX(TM), a vaccine for smoking cessation; and Civacir(TM), an antibody product for the prevention of hepatitis C post-liver transplant. At the end of the third quarter, we had cash and marketable securities totaling $137 million and we will continue to generate cash margins earned on product sales. This assures our ability to accelerate the development of these programs, which are closely aligned with our business strategy and core competencies."
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(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)], its 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.
In addition, the company expects to advance the development of its other vaccine programs, including: NicVAX (Nicotine Conjugate Vaccine), which is currently in Phase IIb clinical trials; its non-capsular polysaccharide-based vaccine for S. aureus (type 336) in Phase I clinical trials; its S. epidermidis vaccine in Phase I clinical trials; and, its community-acquired S. aureus program (PVL) and Enterococcal vaccine in pre-clinical development.
Source: Nabi Biopharmaceuticals