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Clinical trial studies prevention of surgical site infections in cardiac surgery patients

Innocoll Technologies : 03 January, 2008  (New Product)
The first of two phase 3 clinical trials sponsored by Innocoll’s wholly owned subsidiary, Innocoll Technologies, that will investigate CollaRx 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. The Implant is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localised 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 USA) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localised, 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, Innocoll will conduct two multi-centred 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 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 percent when used as an adjunct to standard infection prophylaxis. This was a prospective, randomised, controlled clinical study performed at two hospital centres in Sweden and led by Dr Orjan Friberg, cardiothoracic surgeon at Orebro University Hospital.

Patients in the treatment group had two Gentamicin Implants (260mg total dose) placed between the sternal halves before closure. The primary endpoint (total incidence of SWIs after two months post-surgery) was 9.0 percent in the control group and 4.3 percent in the treatment group (p<0.001). Sub-population analysis of known high-risk groups showed even greater treatment effect; including a 68 percent reduction in infection from 17.3 percent in the control group to 5.6 percent 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 Gentamicin surgical Implant for this indication in Europe. Several such studies have been published, including one prospective, randomised, 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.

According to the latest statistics published by the Pennsylvania Health Care Cost Containment Council (PHC4), one of the few US states mandated to collect such data, patients that contracted a surgical site infection spent an average of 14.5 days in hospital at an average hospital charge of $132,110 compared to 4.7 days and $33,267 for patients that had no hospital-acquired infection.

The same official report stated that 'surgery performed on the large and small intestines represented the largest percentage of surgical site infections at 9.0 percent followed closely by surgery for blockages in blood vessels, including blood vessels of the heart, which accounted for 8.9 percent.'

An independent market research recently performed by LEK Consulting has conservatively projected peak US sales of Gentamicin surgical Implant to be greater than $200 million per annum.

Dr Michael Myers, Innocoll's president and CEO commented, 'As an already approved product in Europe and elsewhere with proven safety, efficacy and pharmacoeconomics, we believe that the development of our Gentamicin Implant for the US market represents an excellent commercial opportunity and value proposition for our shareholders. The commencement of this phase 3 trial, our first in the USA, is a landmark event for the company and demonstrates our full commitment to the clinical development of our exciting pipeline of products.'
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