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 Foot Ulcers

Wednesday, December 19, 2007 General News
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ASHBURN, Va., Dec. 18 Innocoll, Inc., a privately-heldspecialty pharmaceutical company, announced that the first of three plannedphase 2 clinical trials sponsored by its wholly owned subsidiary, InnocollTechnologies Ltd, to investigate CollaRx(R) GENTAMICIN TOPICAL for thetreatment and prevention of infected diabetic foot ulcers, has commenceddosing.

CollaRx GENTAMICIN TOPICAL is a biodegradable and fully resorbableGentamicin-Collagen Sponge formulated and manufactured using Innocoll'sproprietary collagen-based drug delivery technology, CollaRx. Upon applicationto a wound, the product releases gentamicin, a broad-spectrum, aminoglycosideantibiotic (having a concentration-dependent mechanism of action), for localaction. This achieves a high concentration of drug at the target tissue, whilemaintaining low systemic levels well below the toxicity threshold.

CollaRx GENTAMICIN TOPICAL represents the clinical development ofInnocoll's Gentamicin-Collagen Sponge as a therapy for the treatment andprevention of infected chronic wounds. The product is already approved andmarketed in Europe and other non-US territories as a surgical implant for thetreatment of localized, deep tissue infections and the prevention of surgicalsite infections in both hard and soft tissues. The development of the topicalindication is based upon a series of published clinical case studies andanecdotal reports from clinicians where the marketed implant product wasapplied topically to chronic wounds of various etiologies. This data supportsits effectiveness for such clinical applications, particularly in thetreatment of infected diabetic foot ulcers.

Chronic ulcerations are often colonized or contaminated with bacterialpathogens that can prevent ulcers from healing. A high proportion of suchwounds will become clinically infected and require treatment with antibiotics.Orally and parenterally administered antibiotics are often associated withsystemic side effects and widespread use can lead to development of bacterialresistance. Furthermore, diabetic ulcers are often associated with vasculardisease and restricted peripheral blood flow (ischemia), which may rendersystemically acting antibiotics less effective. Infection can also spread tothe bone (osteomyelitis), which is less well vascularized than soft tissue.Currently, there are no topically applied antibiotics marketed in the US thatare specifically indicated for the treatment of infected diabetic foot ulcersand recent market research independently performed by L.E.K. Consultingforecast peak annual revenues for CollaRx GENTAMICIN TOPICAL approachingUS$270 million, when limiting the sales projections to diabetic footindications only.

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

Dr. Michael Myers, Innocoll's President and CEO commented, "Diabetes hasreached epidemic proportions and is continuing to grow at an alarming rateacross the globe. Diabetic foot is one of the major complications of thisdisease, which is a h

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