ASHBURN, Va., March 16 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last patient has been dosed in the first of two ongoing U.S. phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the prevention of surgical site infections.
The trial is being conducted at approximately 50 hospital sites across the U.S. 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); a serious and potentially life-threatening complication of cardiac surgery. Patients in the treatment group have two Gentamicin Implants (260 mg total dose) placed between the sternal halves before chest closure and the primary endpoint is total incidence of SWI after 3 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 sternal wound infection (SWI) by 53 percent, increasing to 68 percent reduction in the higher risk patient population. A health economic analysis of the Swedish study has also been published and concluded that routine prophylactic use of the Gentamicin Implant resulted in a net cost saving per patient.
Patient enrolment in a second phase 3 trial being conducted in patients undergoing open colorectal surgery is expected to close later this month. Innocoll has appointed Duke University’s Duke Clinical Research Institute (DCRI) as the Study Coordinating Center for both phase 3 trials.
Dr. Michael Myers, Innocoll’s President and CEO commented, “We are delighted to have completed patient enrolment in this phase 3 cardiac surgery trial, which we are running in parallel with the second phase 3 trial in colorectal surgery. Previous meetings with FDA have indicated that no other clinical trials are necessary for 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 U.S.”
About Gentamicin Surgical Implant
GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll’s proprietary collagen-based drug delivery technology, CollaRx, and (outside of the U.S.) 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. GENTAMICIN SURGICAL IMPLANT is already approved in 49 countries spanning Europe, Latin America, Middle East, Africa and Asia and there are more than 60 prospective clinical trials and published case reports totaling over 7,500 patients documenting its safety and efficacy over a broad range of orthopedic, colorectal, cardiothoracic, vascular, and neurosurgical procedures. The product is in phase 3 clinical trials in the U.S. for the prevention of surgical site infections and has received FDA fast-track designation for this indication.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). Innocoll has licensed its US marketing rights to its lead product, CollaRx GENTAMICIN SURGICAL IMPLANT to Baxter Healthcare, a division of Baxter International Inc The product is currently in phase 3 development in the US for the prevention of surgical site infections. It is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia. Other late stage pharmaceutical products in Innocoll’s development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit www.innocollinc.com.
CONTACT: Veronica Kelly of Innocoll, Inc., vkelly@innocoll-pharma.com
Web site: http://www.innocollinc.com/
