Innocoll, a biopharmaceutical company, has announced that the last patient has been dosed in the second 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 45 hospital sites across the US and has enrolled 600 patients undergoing open colorectal surgery, which is widely considered to be the most prone to surgical site infection.
Patients in the treatment group have two gentamicin implants (260mg total dose) implanted in the wound before abdominal closure and the primary endpoint is total incidence of surgical site infections after two months post-surgery. The design of the trial is based upon an approved and well-established use of gentamicin surgical implant for this indication in Europe, said Innocoll.
Patient enrollment in the first Phase III trial being conducted in diabetic and obese patients undergoing cardiac surgery closed earlier in March 2009. The company has appointed Duke University’s Duke Clinical Research Institute as the study coordinating center for both Phase III trials.
Michael Myers, Innocoll’s president and CEO, said: Having recently completed patient enrollment in our first Phase III trial in cardiac surgery, we are pleased to have now concluded enrollment in both trials, which FDA has confirmed are the only trials we need for new drug application approval.
As a well-established product in Europe and other non-US markets with proven safety, efficacy and pharmacoeconomics, we believe that a future launch of gentamicin implant in the US market represents excellent commercial opportunity.