ASHBURN, Va., June 18 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced positive provisional findings from its three phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN TOPICAL for the treatment and prevention of infection in diabetic foot ulcers.

Chronic ulcerations such as diabetic foot ulcers are often colonized or contaminated with bacterial pathogens that can prevent ulcers from healing. A high proportion of such wounds become clinically infected and require treatment with antibiotics. Orally and parenterally administered antibiotics are often associated 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.

CollaRx GENTAMICIN TOPICAL is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx. Upon application to an open wound the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic with a concentration-dependent mechanism of action, for local action at the wound site. This technology achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.