Innocoll Announces Dosing of First Patient in Second US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site ...( ASHBURN Va. Feb. 19 /- Innocoll I...),Health

ASHBURN, Va., Feb. 19 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the second of two phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) 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. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized 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 US) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, 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 totaling over 7,500 patients documenting its safety and efficacy over a broad range of orthopedic, 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-centered phase 3 clinical trials in the US 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 Instit
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