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Innocoll begins dosing in surgical implant clinical trial investigating the prevention of SSIs

Innocoll Technologies : 20 February, 2008  (New Product)
The second of two phase 3 clinical trials sponsored by Innocoll Technologies to investigate CollaRx Gentamicin Surgical Implant for the prevention of surgical site infections (SSIs), 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.

According to advice from FDA received at both pre-IND and post-IND meetings held in 2007, Innocoll will conduct two multi-centred phase 3 clinical trials in the USA to support the planned New Drug Application (NDA).

The first trial in cardiac surgery patients at higher risk of surgical site infection commenced in December 2007. The second trial, which has now enrolled its first patient, is in general surgery patients undergoing open colorectal surgery. Innocoll has appointed Duke University's Duke Clinical Research Institute (DCRI) as the Study Coordinating 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.

Open colorectal surgery is widely considered to be the most prone to surgical site infection and 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, 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. Independent market research recently performed by LEK Consulting has conservatively projected peak US sales of Gentamicin Surgical Implant to be greater than US$200 million per annum.

Dr Michael Myers, Innocoll's president and chief executive officer 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. With the commencement of this second phase 3 trial, our sights are now well and truly set on NDA filing once these trials are complete.'
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