Toronto, Canada , September 19, 2000 -- Nabi (Nasdaq: NABI) announced preliminary results from the phase III clinical trial for StaphVAX™ (Staphylococcus aureus conjugate vaccine) at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Toronto, Canada. The data from the trial demonstrated a dramatic reduction in S. aureus bacteremias (blood stream infections) during the first ten months of the study. However, the decrease in bloodstream infections after one-year follow up, the primary endpoint for the study, did not achieve statistical significance. The study was performed by the Kaiser Permanente Vaccine Study Center based in Oakland, CA, and the preliminary results were presented by the principal investigators from that institution, Steven Black, M.D. and Henry Shinefield, M.D.
"We are excited by the data from this trial," said David J. Gury, Chairman, President and Chief Executive Officer of Nabi. "Based on the protection exhibited for StaphVAX treated patients during the first ten months of the trial, we strongly believe that a CPS-conjugated vaccine against S. aureus is feasible. Moreover, the demonstration that StaphVAX-induced antibodies can protect against bloodstream infections has very positive implications for the success of Nabi's entire Gram-positive program."
In reviewing the preliminary results from the trial, Dr. Black stated, "Through ten months, the study results found 57% fewer cases of Staph aureus disease in these immune compromised study participants who received the vaccine. Staph aureus is an increasing, lethal bacteria, which causes significant morbidity and mortality."
Dr. Shinefield affirmed, "These results are particularly important at a time of growing resistance of Staph aureus to antibiotics."
StaphVAX consists of capsular polysaccharides (CPS) from the two most common serotypes of S. aureus (Type 5 and Type 8), each conjugated to a carrier protein. The double-blinded, placebo-
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18-Sep-2000