>>ATLANTA, GA--(MARKET WIRE)--Jan 7, 2005 -- Inhibitex, Inc. (NasdaqNM:INHX - News) today announced that enrollment in its ongoing Phase III clinical trial of Veronate for the prevention of hospital-associated infections in very low birth weight infants has outpaced the Company's initial expectations and that it has enrolled 684, or more than one-third, of the 2,000 patients it intends to enroll in the trial. Additionally, the Company reported that an independent Data Safety Monitoring Board met yesterday to review safety and other data available from the first 500 patients enrolled in the trial and unanimously recommended that the trial proceed as designed without modification.
The Company also announced that it has completed enrollment in its 60-patient Phase II clinical trial of Aurexis in patients with documented Staphylococcus aureus (S. aureus) bloodstream infections.
"We made significant progress over the past six months and ended 2004 well-positioned to achieve our clinical development objectives for both Veronate and Aurexis. We intend to continue to build on this momentum and further drive these programs forward this year," stated William D. Johnston, Ph.D., president and chief executive officer of Inhibitex, Inc. "Based upon the enrollment rate we are achieving and the 90-100 sites in the United States and Canada that we believe will ultimately participate in our Phase III Veronate trial, we are confident that we can complete the enrollment in this trial in the fourth quarter of 2005. We are also pleased to have completed enrollment in our Phase II Aurexis trial on schedule. As we have previously disclosed, we expect to be in a position to publicly discuss this Phase II data in the second quarter of 2005, and intend to study the use of Aurexis in other patient populations in the upcoming year."
Inhibitex also provided additional information regarding the status of its Phase III trial for Veronate, reporting that during November and December, the enrollment rate in the trial averaged approximately 125 patients per month. The Company also said that 72 neonatal intensive care units have been initiated to enroll patients in the trial, and that over 90% have enrolled at least one infant. No single site has enrolled more than 5% of the patients, reflecting broad participation in the trial across a diverse group of sites. In December, the Company enrolled its first patient in Canada, where it expects to have 5-10 sites participate in the trial.<<
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Cheers, Tuck |
