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Innocoll Submits SPA for Cogenzia(TM) Phase III Clinical Trials for the Adjuvant Treatment of Diabetic Foot Infections
Date:7/13/2010

antibiotics, a milestone event for the treatment of this large and rapidly growing unmet medical need."  

Diabetic Foot Ulcers Infections:

Diabetic foot ulcer (DFU) infections represent a large and growing market for Cogenzia.  According to the American Diabetes Association there were 23.6 million diabetic patients in the U.S. in 2007 and 220 million patients globally.  Of these patients, approximately 15% will develop a DFU and 50% of those patients will develop an infected DFU, representing an estimated 2 million patients.   Infected DFUs are currently treated with systemic antibiotics.  However, diabetic ulcers are often associated with limited perfusion due to vascular disease and ischemia thereby rendering systemically acting antibiotics ineffective. According to a meta-analysis of 18 randomized controlled trials evaluating different antibiotics in treatment of diabetic foot infections, the combined observed treatment failure rate of antibiotic treatments of DFU infections is 22.7%. Local antibiotic treatment adjunct to a systemic agent can potentially address the unmet need in infections in DFU by improving anti-bacterial efficacy at the wound site.  There are currently no approved, topically applied antibiotics in the U.S. that are indicated for the treatment of infections in DFU.  

About Cogenzia:  

Cogenzia 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 an open wound the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic with a concentration-dependent mechanism of action, for local action at the wound site. This technology achieves a high concentration of drug at the target tissue, while maintaining low systemic
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SOURCE Innocoll, Inc.
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5. 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
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