FDA News

FDA okeys Migenix's Enrollment in Phase III Clinical Trial of Omigard for Preventing Catheter-Related Infections

(July 29, 20070-- Cadence Pharmaceuticals, announced  that the U.S. Food and Drug Administration (FDA) has agreed with the company's plan to increase the number of patients to be enrolled in the ongoing Phase III clinical trial of its experimental product candidate, Omigard (omiganan pentahydrochloride 1% aqueous gel) from 1,250 to 1,850.

Cadence also announced that in June 2007 it completed enrollment of the original target of 1,250 patients in this clinical trial, which is known as the Central Line Infection Reduction Study, or CLIRS trial, two months
ahead of schedule.

"We are pleased with the strong rate of enrollment in the CLIRS trial, which has allowed us to achieve our original goal two months early. Based upon the current enrollment rate, and the fact that we have continued to
add new clinical trial sites, we anticipate that we will complete enrollment of our new goal, 1,850 patients, in the second quarter of 2008. If the results of this trial are positive, we expect to submit a new drug application, or NDA, for Omigard in the first half of 2009," said Ted Schroeder, Cadence Pharmaceuticals' President and Chief Executive Officer.

"Achieving our initial enrollment objective early supports our belief that there is a significant, unmet medical need for Omigard," said Jim Breitmeyer, the company's Executive Vice President and Chief Medical
Officer. "We greatly appreciate the dedication and commitment of the clinicians and support staff at our clinical trial sites, and our internal project team, whose efforts have made this result possible."

Cadence Pharmaceuticals expects that the expanded enrollment in the CLIRS trial and additional development expenditures associated with the Omigard program will increase the company's total operating expenses for the full year 2007 from between $49 million and $53 million to between $57 million and $60 million, including an estimated $4 to $5 million in non-cash stock-based compensation expenses. Cadence also anticipates that cash, cash equivalents and investments held for sale at December 31, 2007 will be between $35 million and $38 million.

In April 2007, Cadence announced its intention to propose to the FDA an increase in enrollment in the CLIRS trial in order to maintain the statistical power of the study in light of a re-analysis of data from the initial Phase III clinical trial of Omigard. The re-analysis, which used a slightly different, stricter definition for local catheter site infections (LCSIs), indicated a statistically significant reduction of LCSIs of 42% in the Omigard treatment arm as compared to the povidone-iodine treatment arm (the previous analysis indicated an approximately 49% reduction), and indicated that the LCSI rate in the control group was lower than previously believed.

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