CollaRx® Gentamicin Surgical Implant – US
According to the latest (2005) 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 states that "surgery performed on the large and small intestines represented the largest percentage of surgical site infections at 9.0% followed closely by surgery for blockages in blood vessels, including blood vessels of the heart, which accounted for 8.9%".
Innocoll's CollaRx® Gentamicin Surgical Implant is currently in phase III clinical development in the US for the prevention of surgical site infections (SSIs) in patients at risk of infection.
We have been working closely with the FDA to establish the clinical program for this product, and following a pre-IND meeting in 2007, the product was immediately progressed to phase III based on the significant body of data that has been established in Europe, where the product is already marketed. The clinical program includes two phase III trials; the first in cardiac surgery patients at higher risk of surgical site infection. The design of this first phase II trial in diabetic and/or obese patients undergoing cardiac surgery is based upon a recently published 2,000 patient clinical trial demonstrating that the Company's Gentamicin Surgical Implant reduced the incidence of sternal wound infection (SWI) by 53% for all patient populations when used as an adjunct to standard infection prophylaxis. Sub-population analysis of known high risk groups showed even greater treatment effect, most notably a 68% reduction in SWI for patients with diabetes. The second phase III trial is being conducted in patients undergoing colorectal surgery, which is an approved and well established use of the product in Europe. Several such studies have been published, including one prospective, randomized, controlled clinical trial in over 200 patients. The results of this trial showed a 70% decrease in surgical site infections from 18.4% in the control group to 5.6% in the patients treated with the Gentamicin Surgical Implant in conjunction with systemic therapy.