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Phase 3 Trial of Veronate To Continue, Treatment for the Prevention of Hospital-Associated Infections in Premature Infants
"Until the data is unblinded, these communications from the DSMB are our only insight into the potential outcome of this trial, so we are very encouraged with its recommendation," stated William D. Johnston, Ph.D., President and Chief Executive Officer of Inhibitex, Inc. "While we cannot predict the ultimate result of this ongoing trial, the DSMB decision further reinforces our confidence regarding our assumed rate of infection, the adequacy of the statistical design and the powering of the trial relative to its primary endpoint. We continue to expect that top line results from the trial will be available in the second quarter of 2006."
The Company previously reported that the same DSMB had met and reviewed similar clinical data after 500, 1,000 and 1,500 patients had been enrolled in the trial, and in each case, unanimously recommended that the trial should continue as designed, without modification.
Veronate, a novel, antibody-based investigational drug being developed to prevent hospital-associated infections in premature, very low birth weight infants weighing 500-1,250 grams at birth, is the Company's most advanced product candidate. The primary endpoint of the pivotal Phase III trial is to demonstrate efficacy in the prevention of hospital-associated infections due to Staphylococcus aureus (S. aureus) in this infant population Secondary endpoints include a reduction in the frequency of hospital-associated infections due to Candida species (fungus) and Coagulase-negative staphylococci (CoNS), and a reduction in the mortality rate. Veronate has been granted both Fast Track designation and Orphan Drug status in the United States and has been recommended for Orphan Medicinal Product designation in Europe. The Company has retained all world-wide rights to Veronate and, if approved, anticipates commercializing it independently in the United States.
Source: Inhibitex, Inc.