Synergen Inc. announced Monday that it has completed patientenrollment for its Phase III efficacy study of Antril (IL-1ra, orinterleukin -1 receptor antagonist) in sepsis patients.
The randomized, double-blind, placebo-controlled, multicentertrial is being conducted in more than 60 centers in eightcountries and will involve 900 patients.
According to Michael Catalano, vice president of clinicalresearch for the Boulder, Colo., company (NASDAQ:SYGN), thetrial will study the safety and efficacy of two different doses ofIL-1ra in reducing mortality in patients with sepsis.
Data from the Phase II trial in 99 patients suggested thatsurvival improved with increasing doses of IL-1ra, regardlessof the type of infecting organisms -- gram-negative, gram-positive and mixed infections.
"At the highest dose tested in the Phase II trial, patientmortality was 16 percent, a decrease of 64 percent comparedto the placebo group," Catalano said.
IL-1ra is a naturally occurring human protein that inhibits theaction of interleukin-1, a cytokine produced by the body inresponse to infection or injury and an important mediator ofinflammation. Overproduction of IL-1 is implicated inconditions involving inflammation such as sepsis, a conditionthat affects about 1 million people annually in Europe and theU.S.
-- Michelle Slade Associate Editor
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