ASHBURN, Va., March 19 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last patient has been dosed in the second 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 45 hospital sites across the U.S. and has enrolled 600 patients undergoing open colorectal surgery, which is widely considered to be the most prone to surgical site infection (SSI). Patients in the treatment group have two Gentamicin Implants (260 mg total dose) implanted in the wound before abdominal closure and the primary endpoint is total incidence of SSI after 2 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. The results of several such studies have been published, including one prospective, randomized, controlled clinical trial in 221 patients which demonstrated a 70 percent decrease in surgical site infections from 18.4 percent in the control group to 5.6 percent in the patients treated with the implant.
Patient enrolment in the first phase 3 trial being conducted in diabetic and/or obese patients undergoing cardiac surgery closed earlier this month. Innocoll has appointed
Dr. Michael Myers, Innocoll's President and CEO commented, "Having recently completed patient enrollment in our first phase 3 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 NDA approval. As a well established product in Europe and other non-U.S. markets with proven safety, efficacy and pharmacoeconomics, we believe that a future launch of Gentamicin Implant in the U.S. market represents excellent commercial opportunity."
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 a division of Baxter International Inc (NYSE: BAX). 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.
|SOURCE Innocoll, Inc.|
Copyright©2009 PR Newswire.
All rights reserved