January 24, 2007

Innocoll announced that the FDA has approved its investigational new drug application to conduct a Phase II study for CollaRx Gentamicin as a topical antibiotic treatment for mildly infected diabetic foot ulcers. The treatment is a biodegradable and fully resorbable Gentamicin-collagen sponge formulated and manufactured using Innocoll's proprietary CollaRx technology. Upon application to a wound, the product releases gentamicin, a broad-spectrum, concentration-dependent aminoglycoside antibiotic, for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.

CollaRx Gentamicin, as a surgical implant, is already approved and marketed in Europe and elsewhere outside the U.S. as an adjunct to systemic therapy for the treatment and prevention of post-surgical site-acquired infection. Published clinical case studies and anecdotal reports from clinicians using the marketed product suggest its effectiveness in the treatment and cure of infected chronic wounds, including diabetic foot ulcers, according to the company.

Practically all ulcers are colonized with pathogenic bacteria, and a high proportion become clinically infected requiring treatment with antibiotics, Innocoll said. Orally administered and injected antibiotics are often associated with systemic side effects, and widespread use leads 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, which is less well vascularised than soft tissue, according to the company.