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Innocoll Announces Dosing of First Patient in US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections in Cardiac Surgery Patients
Date:1/3/2008

ASHBURN, Va., Jan. 2 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the first of two 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, has commenced dosing.

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 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. 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 totalling over 7,500 patients documenting its safety and efficacy over a broad range of orthopaedic, colorectal, cardiothoracic, vascular, and neurosurgical procedures.

Following a pre-IND meeting with the FDA earlier this year, Innocoll will conduct two multi-centered phase 3 clinical trials in the US to support the planned New Drug Application (NDA); the first in cardiac surgery patients at higher risk of surgical site infection and the second, expected to start later this month, in patients undergoing open colorectal surgery, which is considered to be the category most prone to surgical site infection. Innocoll has appointed Duke University's Duke Clinical Research Institute (DCRI) as
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SOURCE Innocoll, Inc.
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