Innocoll's gentamicin implant enters US trial

USA-based Innocoll, a privately-held pharmaceutical company, says that its wholly-owned subsidiary, Innocoll Technologies, has begun dosing in a Phase III trial designed to assess its Gentamicin Surgical Implant in the prevention of site infections in cardiac surgery patients. The product, which incorporates the firm's CollaRx drug delivery technology, is approved in 49 countries worldwide as an adjunct to systemic therapy for localized deep-tissue infections, as well as for the prevention of surgical site infections.

Innocoll explained that, following discussions with the Food and Drug Administration, it will conduct two Phase III assessments to support a planned New Drug Application. The second trial, which is expected to start later this month, will examine the implant in patients undergoing open colorectal surgery.

The current study, which is recruiting subjects who are diabetic or obese, is based on an assessment conducted by Swedish researchers in which the implant was shown to cut the incidence of sternal wound infection some 53% when used as an adjunct to standard treatment. Sub-population analysis of data from the study indicated that diabetic patients who received the implant experienced a 68% reduction in the occurrence of infection.