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Innocoll Announces Provisional Findings From Its Three Phase 2 Clinical Trials Investigating CollaRx(R) GENTAMICIN TOPICAL for the Treatment and Prevention of Diabetic Foot Infections
Date:6/18/2009

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. The product concept and technology is featured in an article co-authored by David G Armstrong and Andrew Boulton et al in this month's Expert Opinion on Drug Delivery (full reference: The use of gentamicin-impregnated foam in the management of diabetic foot infections: a promising delivery system?; Catherine D Griffis, Stuart Metcalfe, Frank L Bowling, Andrew JM Boulton, David G Armstrong, Expert Opinion on Drug Delivery, June 2009, Vol. 6, No. 6, Pages 639-642).

CollaRx GENTAMICIN TOPICAL is currently under investigation for the treatment and prevention of diabetic foot infections of varying severity (uninfected, mildly infected and moderately infected as defined according to Infectious Disease Society of America guidelines) in a series of multi-centred phase 2 clinical trials:

One study is investigating the product as an adjunct to systemic antibiotic therapy for treating moderately infected ulcers compared to systemic therapy alone. For patients randomized to the treatment group, one active sponge is administered on a daily basis. Provisional findings from this trial have indicated 100% treatment success, as defined by achievement of clinical cure during the 4 week treatment period, for patients receiving CollaRx GENTAMICIN TOPICAL compared to 80% in the control group receiving standard therapy alone. Comprehensive results from this trial are expected in July 2009.

Another study is investigating the product for the treatment of mildly infected diabetic ulcers. The safety and efficacy of low dose CollaRx GENTAMICIN TOPICAL (one 5cm x 5cm sponge containing 32.5mg gentamicin administered daily) is compared to once daily 750mg oral levofloxacin (the current standard of care at its recommended maximum daily dose) in a prospective, randomized design. The study is fully enrolled and provisional findings indicate that mono-antibiotic therapy with CollaRx GENTAMICIN TOPICAL results in a similar number of clinical cures/improvements as the comparator establishing that the product could indeed be most effective as a stand alone treatment. Furthermore, the preliminary pharmacokinetic data have consistently demonstrated extremely low systemic concentrations of gentamicin in line with expectations for the delivery system. Final clinical, microbiological and pharmacokinetic results of this trial are expected in August 2009.

The third phase 2 trial is evaluating the product for the prevention of diabetic ulcer infection versus placebo control (collagen sponge) in a randomized, double-blind design. In this study, one 5cm x 5cm sponge (containing 32.5mg gentamicin in the treatment group) was administered twice weekly for the first 4 weeks and once weekly for a further 8 weeks. Provisional findings indicate a much reduced infection rate of 6% in the treatment group versus 36% for the placebo control. Completion of a more detailed statistical analysis is expected by July 2009.

Dr. Michael Myers, Innocoll's President and CEO commented, "These provisional findings from our US phase 2 program of three controlled clinical trials are most encouraging. We are particularly pleased to report 100% treatment success in the moderately infected ulcer study indicating that use of our product has the potential to address a very significant and rapidly growing unmet medical need."

About Innocoll, Inc.

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). Innocoll has licensed its US marketing rights to its lead product, CollaRx GENTAMICIN SURGICAL IMPLANT to Baxter Healthcare, a division of Baxter International Inc (NYSE: BAX) The product is currently in phase 3 development in the US for the prevention of surgical site infections. It is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia. Other late stage pharmaceutical products in Innocoll's development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit www.innocollinc.com.


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