Centocor Inc. said Thursday it will resume a placebo-controlledtrial of HA-1A/Centoxin in children with fulminantmeningococcemia under a U.S. investigational new drug (IND)application.

Enrollment of patients with this gram-negative infection hadbeen suspended on Jan. 18.

The Safety and Efficacy Monitoring Committee for this trial hasrecommended resuming the study after reviewing the datafrom interim analyses in both this trial and a separate trial thatwas investigating the utility of HA-IA in treating adults withseptic shock and gram-negative bacteremia, the Malvern, Pa.,company (NASDAQ:CNTO) said.

Although fulminant meningococcemia can be life-threatening,children with this disease -- unlike many adults with sepsis --tend not to have additional, underlying diseases thatthemselves can be life threatening.

The effect of HA-1A on mortality in the meningococcemiaindication might be more clearly measured than its effect inother indications studied to date, including septic shock andgram-negative bacteremia in adults, the company said.

Also, children with clinical signs and symptoms ofmeningococcemia tend to have a higher incidence of gram-negative bacteremia than adults with sepsis, so a higherportion of patients may potentially benefit from HA-1Atreatment.

The trial of HA-1A in patients with septic shock and gram-negative bacteremia is still suspended, pending furthercollection and study of data from the interim analysis in thattrial. The interim analysis showed that the mortality rateamong HA-1A patients who did not have gram-negativebacteremia exceeded the rate in placebo-treated patients to anextent specified in a trial-stopping rule.

Centocor's stock was up 50 cents a share on Thursday, closingat $7.25.

-- Nancy Garcia Associate Editor

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