Cadence Pharmaceuticals to Increase Enrollment in Omigard Trial
Cadence Pharmaceuticals announced that the FDA has agreed to the company’s plan to increase the number of patients from 1,250 to 1,850 in the ongoing Phase III clinical trial of its experimental product, Omigard, for the treatment of local catheter site infections, (LCSI).
According to Cadence, the company completed enrollment of the original target in the Omigard (omiganan pentahydrochloride 1 percent aqueous gel) trial, which is known as the Central Line Infection Reduction Study (CLIRS), two months ahead of schedule.
Ted Schroeder, Cadence’s president and CEO, said that he anticipates the company will reach its new enrollment goal in the second quarter of 2008.
He added that if the results of this trial are positive, he expects the company to submit a new drug application in the first half of 2009.
According to the company, the CLIRS trial is a multicenter, randomized, evaluation committee-blinded study in patients whose medical condition requires a central venous catheter.
The primary efficacy endpoint of the clinical trial is to evaluate whether Omigard is superior to 10 percent povidone-iodine in the prevention of LCSI, the company added.