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Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections
Date:4/30/2008

ASHBURN, Va., April 30 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last of three planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN TOPICAL for the treatment and prevention of infected diabetic foot ulcers, has commenced dosing. CollaRx GENTAMICIN TOPICAL is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx. Upon application to a wound, the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic (having a concentration-dependent mechanism of action), for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.

The product is already approved and marketed in Europe and other non-US territories as a surgical implant for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues; and is also in Phase 3 clinical development in the US for the prevention of surgical site infections. The development of the topical indication is based upon a series of published clinical case studies and anecdotal reports from clinicians where the marketed implant product has been used topically for treatment of infected chronic wounds of various etiologies. These data support its effectiveness for such clinical applications, particularly in the treatment of infected diabetic foot ulcers.

CollaRx GENTAMICIN TOPICAL is currently under investigation for the treatment and prevention of diabetic foot infections of varying severity in a series of multi-centred phase 2 clinical trials. The first and second trials are investigating the product as a mono-antibiotic therapy for the treatment of mildly infected diabetic ulcers and as an adjunct to sy
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SOURCE Innocoll, Inc.
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