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Innocoll Announces Provisional Findings From Its Three Phase 2 Clinical Trials Investigating CollaRx(R) GENTAMICIN TOPICAL for the Treatment and Prevention of Diabetic Foot Infections
Date:6/18/2009

uring the 4 week treatment period, for patients receiving CollaRx GENTAMICIN TOPICAL compared to 80% in the control group receiving standard therapy alone. Comprehensive results from this trial are expected in July 2009.

Another study is investigating the product for the treatment of mildly infected diabetic ulcers. The safety and efficacy of low dose CollaRx GENTAMICIN TOPICAL (one 5cm x 5cm sponge containing 32.5mg gentamicin administered daily) is compared to once daily 750mg oral levofloxacin (the current standard of care at its recommended maximum daily dose) in a prospective, randomized design. The study is fully enrolled and provisional findings indicate that mono-antibiotic therapy with CollaRx GENTAMICIN TOPICAL results in a similar number of clinical cures/improvements as the comparator establishing that the product could indeed be most effective as a stand alone treatment. Furthermore, the preliminary pharmacokinetic data have consistently demonstrated extremely low systemic concentrations of gentamicin in line with expectations for the delivery system. Final clinical, microbiological and pharmacokinetic results of this trial are expected in August 2009.

The third phase 2 trial is evaluating the product for the prevention of diabetic ulcer infection versus placebo control (collagen sponge) in a randomized, double-blind design. In this study, one 5cm x 5cm sponge (containing 32.5mg gentamicin in the treatment group) was administered twice weekly for the first 4 weeks and once weekly for a further 8 weeks. Provisional findings indicate a much reduced infection rate of 6% in the treatment group versus 36% for the placebo control. Completion of a more detailed statistical analysis is expected by July 2009.

Dr. Michael Myers, Innocoll's President and CEO commented, "These provisional findings from our US phase 2 program of three controlled clinical trials are most encouraging. We are particularly pleased to
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SOURCE Innocoll, Inc.
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