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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

ects and widespread use can lead to development of bacterial resistance. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow (ischemia), which may render systemically acting antibiotics less effective. Infection can also spread to the bone (osteomyelitis), which is less well vascularized than soft tissue. Currently, there are no topically applied antibiotics marketed in the US that are specifically indicated for the treatment of infected diabetic foot ulcers and recent market research independently performed by L.E.K. Consulting forecast peak annual US sales revenues for CollaRx GENTAMICIN TOPICAL approaching US$270 million, when limiting the sales projections to diabetic foot indications only.

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 2 clinical trials. The first of these trials, which commenced in late 2007, is investigating the product as a mono-antibiotic therapy for the treatment of mildly infected diabetic ulcers where the safety and efficacy of CollaRx GENTAMICIN TOPICAL will be compared to an orally administered antibiotic (the current standard of care). This second phase 2 trial will investigate the product as an adjunct to systemic antibiotic therapy for treating moderately infected ulcers, as defined according to Infectious Disease Society of America (IDSA) guidelines. The third phase 2 trial, planned to commence later this month, will investigate the product for the prevention of infection in diabetic foot ulcers.

Dr. Michael Myers, Innocoll's President and CEO commented, "Our Gentamicin-Collagen sponge is already used successfully in Europe and elsewhere as an adjunct for the treatment diabetic foot infections, where physicians have reported it can help to salvage limbs that may otherwise be amputated. Since there are currently no topical antibiotics o
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SOURCE Innocoll Inc
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