Cadence’s confirmatory Phase III clinical trial of Omigard (omiganan pentahydrochloride 1% gel), known as the Central Line Infection Reduction Study (CLIRS), is a randomized, evaluator-blinded study in hospitalized patients whose medical condition requires a short-term central venous catheter.
The primary objective of CLIRS is to evaluate the efficacy and safety of Omigard compared to 10% povidone-iodine in reducing local catheter site infections. The company achieved its goal of enrolling 1,850 patients at 58 clinical trial sites in the US and Europe. CLIRS is being conducted under a special protocol assessment with the FDA. Cadence currently expects to announce top-line data from CLIRS in the second half of 2008 and, if the results are positive, submit an NDA for Omigard to the FDA in the first half of 2009.
James Breitmeyer, executive vice president, development and chief medical officer of Cadence, said: “If approved, we believe that Omigard will address a rapidly growing need for more effective ways to lower hospital acquired infection rates, including the dangerous and costly complications from infections related to intravascular catheters.”