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GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behindsurgical implant impregnated with the broad spectrum aminoglycosideantibiotic, gentamicin. It is designed to provide a high concentration ofgentamicin (which has a concentration-dependent mechanism of action) directlyto the target tissue for localized action, while maintaining low systemiclevels well below the toxicity threshold. The product was developed usingInnocoll's proprietary collagen-based drug delivery technology, CollaRx, and(outside of the US) is indicated as an adjunct to systemic antibiotic therapyfor the treatment of localized, deep tissue infections and the preventionof surgical site infections in both hard and soft tissues. GENTAMICIN SURGICALIMPLANT is already approved in 49 countries spanning Europe, Latin America,Middle East, Africa and Asia and there are more than 60 prospective clinicaltrials and published case reports totalling over 7,500 patients documentingits safety and efficacy over a broad range of orthopaedic, colorectal,cardiothoracic, vascular, and neurosurgical procedures.
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Following a pre-IND meeting with the FDA earlier this year, Innocoll willconduct two multi-centered phase 3 clinical trials in the US to support theplanned New Drug Application (NDA); the first in cardiac surgery patients athigher risk of surgical site infection and the second, expected to start laterthis month, in patients undergoing open colorectal surgery, which isconsidered to be the category most prone to surgical site infection. Innocollhas appointed Duke University's Duke Clinical Research Institute (DCRI) as theStudy Co-ordinating Center for both trials. Approximately 50 sites will berecruited for the trial in patients undergoing cardiac surgery and 35 sitesfor the colorectal surgery trial.
The cardiac surgery trial will enroll diabetic and/or obese (BMI>30)patients known to be at a higher risk of sternal wound infections, a seriousand potentially life-threatening complication of cardiac surgery. The trialdesign is based upon a published 2,000 patient clinical trial demonstratingthat the implant significantly reduced the incidence of sternal woundinfection (SWI) by 53% when used as an adjunct to standard infectionprophylaxis. This was a prospective, randomized, controlled clinical studyperformed at two hospital centers in Sweden and led by Dr. Orjan Friberg,Cardiothoracic Surgeon at Orebro University Hospital. Patients in thetreatment group had two Gentamicin Implants (260 mg total dose) placed betweenthe sternal halves before closure. The primary endpoint (total incidence ofSWIs after 2 months post-surgery) was 9.0% in the control group and 4.3% inthe treatment group (p<0.001). Sub-population analysis of known high-riskgroups showed even greater treatment effect; including a 68% reduction ininfection from 17.3% in the control group to 5.6% in the treatment group forpatients with diabetes. Using the data generated in this cardiac surgerytrial, a health economic analysis was performed and published showing thatroutine prophylactic use of the Gentamicin Implant resulted in a net costsaving per patient.
The design of the second trial in patients undergoing colorectal surgeryis based upon an approved and well established use of GETAMICIN SURGICALIMPLANT for this indication in Europe. Several such studies have beenpublished, including one prospective, randomized, controlled clinical trial in221 patients which demonstrated a 70% decrease in surgical site infectionsfrom 18.4% in the control group to 5.6% in the patients treated with theimplant.
