Synergen Inc. announced Tuesday that it has begun patientenrollment for its follow-up clinical trial of Antril on patientswith severe sepsis.
The randomized, double-blind, placebo-controlled trial is beingconducted in 11 countries in North America and Europe, andinvolves about 75 medical centers, the company said.Synergen (NASDAQ:SYGN) of Boulder, Colo., said it hopes toaccumulate further evidence of the efficacy and safety of Antril-- interleukin-1 receptor antagonist, or IL-1ra -- comparedwith placebo in increasing survival time in patients withpresumed severe sepsis and a 28-day predicted risk ofmortality of at least 24 percent at study entry. About 900evaluable patients will be enrolled.
Although data submitted to FDA in February were insufficientto win broad approval for Antril, the company said the drugappeared to be most effective in high-risk patients, who had apredicted risk of mortality of at least 24 percent.
Synergen's announcement on Tuesday is in keeping with itsprediction that it would begin the follow-up Antril study in thethird quarter. And it's also in line with the model developed byCowen & Co. analysts, who had foreseen that the trial wouldbegin this quarter, said analyst Joyce Lonergan. "We continueto maintain a TneutralU rating on the stock," Lonergan toldBioWorld. "Synergen is perceived as a sepsis company, and itwill move with the rest of the group," she added.
For its second quarter ended June 30, Synergen reported cash,cash equivalents and short-term investments of about $193million. Synergen's stock was up 50 cents a share on Tuesday,closing at $10.75.
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