Innocoll Inc., a privately-held specialty pharmaceutical company, announced that its wholly owned subsidiary, Innocoll Technologies Ltd, has filed an Investigational New Drug (IND) application for its CollaRx Gentamicin Surgical Implant, which is under development for the prevention of surgical site infections as an adjunct to standard infection prophylaxis.
Following the positive outcome to a pre-IND meeting with the FDA held earlier this year, Innocoll is proposing to conduct two multi-cantered phase III clinical trials in the US to support a future New Drug Application (NDA) submission.
This is the third IND that Innocoll has filed in the last six months following similar submissions for the topical use of CollaRx Gentamcin in the treatment of infected diabetic foot ulcers and for its CollaRx Bupivacaine Implant in the management of post-operative pain, both of which are already approved.
Innocoll has appointed Duke University's Duke Clinical Research Institute (DCRI) as the Study Co-ordinating Centre for the two planned phase III clinical trials with the Gentamicin Implant; one in cardiac surgery patients at higher risk of surgical site infection and the other in patients undergoing open colorectal surgery where the risk of surgical site infection is widely recognised to be in the range of 15 to 30 per cent.
The design of the first of these two trials in diabetic or obese (BMI=30) patients undergoing cardiac surgery will be based upon a recently published 2,000 patient clinical trial demonstrating that Innocoll's Gentamicin Implant reduced the incidence of sternal wound infection (SWI) by 53 per cent for all patient populations 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 Örjan Friberg, Cardiothoracic Surgeon at Örebro 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 per cent in the control group and 4.3 per cent in the treatment group. Sub-population analysis of known high-risk groups showed even greater treatment effect, including a 68 per cent reduction in infection from 17.3 per cent in the control group to 5.6 per cent 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 the Gentamicin Implant for this indication in Europe. Several such studies have been published, including one prospective, randomised, controlled clinical trial in 221 patients. The results of this trial showed a 70 per cent decrease in surgical site infections from 18.4 per cent per in the control group to 5.6 per cent in the patients treated with the Gentamicin Implant.
According to the latest (2005) statistics published by the Pennsylvania Health Care Cost Containment Council (PHC4), one of the few U.S. 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 per cent followed closely by surgery for blockages in blood vessels, including blood vessels of the heart, which accounted for 8.9 per cent".
Dr Michael Myers, Innocoll's President and CEO commented " This IND taken together with our already approved INDs, clearly demonstrates Innocoll's commitment to invest in its future and in its exciting pipeline of products under development. The Gentamicin Surgical Implant is our first product to enter phase 3 in the US and we remain on track for our previously stated target of NDA submission in 2008, with the prospect of launching the product in 2009".
CollaRx is Innocoll's lead technology platform for the site specific targeted delivery of a wide variety of drugs with particular emphasis on antibiotics and anaesthetics. The CollaRx technology also forms the basis of Innocoll's lead product, Gentamicin Surgical Implant, a biodegradable leave-behind implant indicated for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues.