Nabi says expert panel will assess company's infections program, phase 3 failure of StaphVAX

By E. Janene Geiss

Philadelphia, Dec. 20 - Nabi Biopharmaceuticals announced Tuesday that it has formed a panel of outside experts in immunology, vaccines, bacterial infections and nephrology to help assess the future development of its Gram-positive infections programs.

The panel was put together in response to Nabi's decision, announced Nov. 1, to halt development of its lead candidate StaphVAX after it failed to meet its primary endpoint in the company's phase 3 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.

To reduce expenses since StaphVAX's phase 3 failure, and in conjunction with the withdrawal of the Market Authorization Application for StaphVAX in Europe, the company announced Monday that it would close its European operations.

As part of its efforts to continue to assess the phase 3 results, the panel met for the first time on Thursday.

Officials said the group outlined its initial goals, which include conducting a complete review of the preclinical and clinical data from the company's S. aureus vaccine and antibody programs, focusing on the different results from two StaphVAX [Staphylococcus aureus Polysaccharide Conjugate Vaccine] phase 3 studies, along with sharing the latest developments in understanding S. aureus bloodstream infections and the patients at risk for these infections.

Members of the panel include:

• Michael M. Frank, former chairman of pediatrics at Duke University Medical Center;

• Dan M. Granoff, senior scientist at Children's Hospital Oakland Research Institute;

• Harry Jennings, group leader of glycoconjugates and tumor immunology at the National Research Council Institute of Biological Sciences;

• Richard M. Krause, senior investigator at Lab of Human Bacterial Pathogenesis, National Institutes of Allergy and Infectious Diseases at The National Institutes of Health;

• Frank Lowy, professor of medicine and pathology at Columbia University College of Physicians and Surgeons;

• John Robbins, chief of LDMI at National Institute of Child Health and Human Development at The National Institutes of Health; and

• Ravi Thadhani, associate professor of medicine at Harvard Medical School.

The panel said it would advise the company on the most appropriate steps to advance the clinical development of the company's Gram-positive infections portfolio, which includes its S. aureus, S. epidermidis and Enterococcus vaccine and antibody product candidates, officials said.

The company expects that these objectives will be accomplished during the first six months of 2006.

Efforts also include a review of the design and conduct of the clinical trial and the initiation of a series of scientific experiments to help interpret the trial results.

The company said it also has completed a series of individual consultations with external experts in the United States and Europe, including some members of the advisory panel.

"Nabi Biopharmaceuticals remains committed to developing products that enable the immune system to prevent significant medical problems, such as staph infections, before they can cause harm to patients. The increasing focus of thought leaders and public policy makers on products that combine clear, demonstrated patient advantages with cost of care benefits, will continue to drive interest in effective prevention approaches," Thomas H. McLain, chairman, chief executive officer and president of Nabi, said in the release.

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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