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news.Collarx Gentamicin is intended for the treatment and prevention of infection in diabetic foot ulcers
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Innocoll has declared positive provisional findings from its three phase-II clinical trials, to investigate collarx gentamicin topical for the treatment and prevention of infection in diabetic foot ulcers.
Collarx gentamicin topical is a biodegradable and fully resorbable Gentamicin-Collagen Sponge, formulated and manufactured using Innocoll’ proprietary collagen-based drug delivery technology, Collarx.
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-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. Provisional findings from this trial indicated 100% treatment success, as compared to 80% in the control group receiving standard therapy alone.
Another study is investigating the product for the treatment of mildly infected diabetic ulcers. 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.
The third phase-II trial is evaluating the product for the prevention of diabetic ulcer infection versus placebo control (collagen sponge) in a randomized, double-blind design. Provisional findings indicate a much reduced infection rate of 6% in the treatment group, versus 36% for the placebo control.
Dr. Michael Myers, President and CEO, Innocoll, said: These provisional findings from our US phase 2 program of three controlled clinical trials are most encouraging. We are particularly pleased to report 100% treatment success in the moderately infected ulcer study indicating that use of our product has the potential to address a very significant and rapidly growing unmet medical need.