Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic F...(with systemic side effects and widesprea...),Health

Date:12/18/2007

with systemic side effects 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 revenues for CollaRx GENTAMICIN TOPICAL approaching US$270 million, when limiting the sales projections to diabetic foot indications only.

Innocoll plans to study CollaRx GENTAMICIN TOPICAL for the treatment of diabetic foot infections of varying severity in a series of phase 2 trials and has appointed the full-service Clinical Research Organization, Premier Research Group, to co-ordinate the trials and provide US regulatory support. The first of these trials is for the treatment of mildly infected diabetic ulcers, as defined according to Infectious Disease Society of America (IDSA) guidelines, where the safety and efficacy of CollaRx GENTAMICIN TOPICAL will be compared to an orally administered antibiotic (the current standard of care). This is a multi-centred trial performed at ten sites, nine in the US and one in the UK. In two subsequent controlled, multi-centered phase 2 trials due to commence in early 2008, Innocoll will investigate the product as an adjunct to systemic therapy for treating moderately infected ulcers and also as a therapy to prevent ulcers from becoming clinically infected.

Dr. Michael Myers, Innocoll's President and CEO commented, "Diabetes has reached epidemic proportions and is continuing to grow at an alarming rate across the globe. Diabetic foot is one of the major complications of this disease, which
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SOURCE Innocoll, Inc. Copyright©2007 PR Newswire. All rights reserved

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