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Innocoll Announces Dosing of Last Patient in US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Cardiac Surgery Patients
Date:3/16/2009

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 s
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SOURCE Innocoll, Inc.
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2. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections
3. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Moderately Infected Diabetic Foot Ulcers
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6. 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
7. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic Foot Ulcers
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