Innocoll initiates dosing in Phase III cardiac surgery trial

Following a pre-IND meeting with the FDA, Innocoll will conduct two multi-centered Phase III clinical trials in the US to support the planned new drug application; the first in cardiac surgery patients at higher risk of surgical site infection and the second in patients undergoing open colorectal surgery, which is considered to be the category most prone to surgical site infection. Innocoll has appointed Duke Clinical Research Institute (DCRI) as the study co-ordinating center for both trials. Approximately 50 sites will be recruited for the trial in patients undergoing cardiac surgery and 35 sites for the colorectal surgery trial.

The cardiac surgery trial will enroll diabetic or obese (BMI>30) patients known to be at a higher risk of sternal wound infections, a serious and potentially life-threatening complication of cardiac surgery.

Gentamicin surgical implant is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. The product was developed using Innocoll’s proprietary collagen-based drug delivery technology, CollaRx, and (outside of the US) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues.

Michael Myers, president and CEO of Innocoll, said: “We believe that the development of our Gentamicin implant for the US market represents an excellent commercial opportunity and value proposition for our shareholders.”