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Innocoll Announces Dosing of Last Patient in Second US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Colorectal Surgery Patients
Date:3/19/2009

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 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, "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 pharm
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SOURCE Innocoll, Inc.
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1. 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
2. Innocoll Announces Dosing of Last Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-Operative Pain
3. 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
4. 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
5. Innocoll Announces Dosing of First Patient in Second US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections
6. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain
7. 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
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