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Innocoll reports positive findings from three Phase II foot ulcer trials
Jun 19, 2009 (Datamonitor via COMTEX) --
Innocoll, a biopharmaceutical company, has reported positive provisional findings from its three Phase II clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx gentamicin topical for the treatment and prevention of infection in 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-centered Phase II clinical trials.
One study is investigating the product as an adjunct to systemic antibiotic therapy for treating moderately infected ulcers compared to systemic therapy alone. For patients randomized to the treatment group, one active sponge is administered on a daily basis.
According to Innocoll, provisional findings from this trial have indicated 100% treatment success, as defined by achievement of clinical cure during the four 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 is compared to once daily 750mg oral levofloxacin 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 II trial is evaluating the product for the prevention of diabetic ulcer infection versus placebo control in a randomized, double-blind design. In this study, one 5cm x 5cm sponge was administered twice weekly for the first four weeks and once weekly for a further eight weeks. Provisional findings indicate a much reduced infection rate of 6% in the treatment group compared to 36% for the placebo control. Completion of a more detailed statistical analysis is expected by July 2009.
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