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Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Moderately Infected Diabetic Foot Ulcers
Date:4/17/2008

ASHBURN, Va., April 17 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the second 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.

CollaRx GENTAMICIN TOPICAL is the clinical development of Innocoll's Gentamicin-Collagen Sponge as a therapy for the treatment and prevention of infected chronic wounds. 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. 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 was applied topically to chronic wounds of various etiologies. These data support its effectiveness for such clinical applications, particularly in the treatment of infected diabetic foot ulcers.

Chronic ulcerations are often colonized or contaminated with bacterial pathogens that can prevent ulcers from healing. A high proportion of such wounds becomes clinically infected and requires treatment with antibiotics. Orally and parenterally administered antibiotics are often associated with systemic side eff
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