从Innocoll公司表了解到，该公司通过3项II期临床实验结果证实，其在研新药 CollarxGentamicin效果显著。该药用于治疗和预防糖尿病足部溃疡，属局部用药。
      
   II期临床实验中第一项实验主要检测Collarx Gentamicin作为辅助用药与全身性抗生素联用治疗中度溃疡的效果，并且将于单用全身性抗生素的疗效进行对比。结果表明，受试组药物的治愈率达到100%，而标准疗法对照组的治愈率则为80%。第二项临床实验检测Collarx Gentamicin治疗轻度溃疡的效果。结果表明，该药在治愈率和病情缓解率方面与单用抗生素效果相当。而第三项临床实验则属于随机双盲型实验，期间对比了CollarxGentamicin和安慰剂在预防溃疡方面的效果。结果发现，受试组患者用药后发病率降低了42%，而安慰剂对照组的发病率降低了36%。
      
   CollarxGentamicin为庆大霉素软胶纱布，可完全实现生物降解和吸收。Innocoll公司通过其自身独有的Collarx软胶给药技术进行生产。
   据了解，足部溃疡是糖尿病最常见和严重并发症之一。发生率约为糖尿病病人的25%，糖尿病病程超过20年者发生率几近50%。四周神经营养障碍和肢体缺血是糖尿病病人并发足部溃疡的主要原因。足部溃疡常合并感染和足趾坏疽，需合理应用抗生素和清创术，严重者需截趾和截肢；动脉旁路尤其是患肢远侧段动脉旁路术能提高救肢率。

Innocoll Announces Provisional Findings From Its Three Phase 2 Clinical Trials Investigating CollaRx® GENTAMICIN TOPICAL for the Treatment and Prevention of Diabetic Foot Infections 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 leadtodevelopment of bacterial resistance. Furthermore, diabeticulcersareoftenassociated 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.
 Theproduct 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 couldindeed 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 placebocontrol. 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."