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Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections
Date:4/30/2008

stemic antibiotic therapy for treating moderately infected ulcers, as defined according to Infectious Disease Society of America (IDSA) guidelines. This third and final phase 2 trial will investigate the product for the prevention of diabetic foot infections.

Chronic ulcerations are often colonized or contaminated with bacterial pathogens that can prevent ulcers from healing. Many such wounds become clinically infected and require treatment with antibiotics. However, early diagnosis of diabetic foot infections is a clinical challenge as typical signs and symptoms of infection, such as pain, redness, or elevated circulating inflammatory markers, can be absent in individuals with neuropathic or neuroischaemic ulcers. Failure to diagnose and treat such infections can lead rapidly to the infection spreading, with the possibility of tissue necrosis, gangrene, osteomyelitis, and ultimately the prospect of a lower leg amputation.

Currently there are no antibiotics on the market specifically indicated for the prevention of diabetic foot infections. There is also reluctance by practitioners to use existing, systemically-acting antibiotics prophylactically because of concerns with systemic side effects and fear of propagating bacterial resistance with widespread use. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow, which may render systemically acting antibiotics less effective. By achieving very high localized concentrations of antibiotic, CollaRx GENTAMICIN TOPICAL is designed to overcome these concerns and this trial has received support from leading podiatrists and infectious disease specialists in the US as the first of its kind. Market research independently performed by L.E.K. Consulting has forecast peak annual US sales revenues for CollaRx GENTAMICIN TOPICAL approaching US$270 million, when limiting the sales projections to diabetic foot indications only.

Dr. Michael Myers, Innocoll's P
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SOURCE Innocoll, Inc.
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