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 Surger... (the Study Co-ordinating Center for both ...)

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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

the Study Co-ordinating Center for both trials. Approximately 50 sites will be recruited for the trial in patients undergoing cardiac surgery and 35 sites for the colorectal surgery trial.

The cardiac surgery trial will enroll diabetic and/or obese (BMI>30) patients known to be at a higher risk of sternal wound infections, a serious and potentially life-threatening complication of cardiac surgery. The trial design is based upon a published 2,000 patient clinical trial demonstrating that the implant significantly reduced the incidence of sternal wound infection (SWI) by 53% when used as an adjunct to standard infection prophylaxis. This was a prospective, randomized, controlled clinical study performed at two hospital centers in Sweden and led by Dr. Orjan Friberg, Cardiothoracic Surgeon at Orebro University Hospital. Patients in the treatment group had two Gentamicin Implants (260 mg total dose) placed between the sternal halves before closure. The primary endpoint (total incidence of SWIs after 2 months post-surgery) was 9.0% in the control group and 4.3% in the treatment group (p<0.001). Sub-population analysis of known high-risk groups showed even greater treatment effect; including a 68% reduction in infection from 17.3% in the control group to 5.6% in the treatment group for patients with diabetes. Using the data generated in this cardiac surgery trial, a health economic analysis was performed and published showing that routine prophylactic use of the Gentamicin Implant resulted in a net cost saving per patient.

The design of the second trial in patients undergoing colorectal surgery is based upon an approved and well established use of GETAMICIN SURGICAL IMPLANT for this indication in Europe. Several such studies have been published, including one prospective, randomized, controlled clinical trial in 221 patients which demonstrated a 70% decrease in surgical site infections from 18.4% in the control group to 5.6% in the patients treated with the
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