Innocoll completes dosing in Phase III surgical site infections trial

Innocoll, a biopharmaceutical company, has reported that the last patient has been dosed in the first of two ongoing US Phase III clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx gentamicin surgical implant for the prevention of surgical site infections.

The trial is being conducted at approximately 50 hospital sites across the US and has enrolled 1,500 diabetic and/or obese (BMI>30) patients undergoing cardiac surgery. Such patients are generally recognized to be at higher risk of developing sternal wound infections (SWI).

Patients in the treatment group have two gentamicin implants (260mg total dose) placed between the sternal halves before chest closure and the primary endpoint is total incidence of SWI after three months post-surgery. The trial design was based on a published 2,000 patient clinical trial performed in Sweden which demonstrated that the implant significantly reduced the incidence of SWI by 53%, increasing to 68% reduction in the higher risk patient population.

Patient enrollment in a second Phase III trial being conducted in patients undergoing open colorectal surgery is expected to close later in March 2009. Innocoll has appointed Duke University’s Duke Clinical Research Institute as the study coordinating center for both Phase III trials.

Michael Myers, president and CEO of Innocoll, said: We are delighted to have completed patient enrolment in this Phase III cardiac surgery trial, which we are running in parallel with the second Phase III trial in colorectal surgery. Previous meetings with FDA have indicated that no other clinical trials are necessary for new drug application (NDA) approval and so we are eagerly awaiting the results of both trials in anticipation of our NDA filing and future commercial launch of the product in the US.