DraxImage, a division of radiopharmaceutical firm Draxis Health of Mississauga, Ontario, has received Health Canada approval to begin phase II clinical studies of its radiopharmaceutical Infecton. The agent is designed to detect and determine the location of infection in patients with signs and symptoms that are difficult to diagnose.
The product combines the antibiotic ciprofloxacin with the radioisotope technetium-99m, and has the potential to selectively distinguish infection from inflammation by binding directly with an essential component of the bacterial DNA replication system, the company said.
The first of the two phase II studies is a single-dose, open-label, multicenter trial involving 30 diabetic patients with clinically confirmed bacterial infections of the foot. Enrollment will begin in August 2003, and the study is expected to be completed by the end of 2003.
A second study to describe the time-dependent imaging characteristics of the agent, and determine the potential to distinguish between an area of infection and an area of inflammation based on kinetics and imaging patterns, will begin in August 2003 and continue until early in 2004. It will examine and compare the uptake of Infecton in patients either with known soft-tissue infections or chronic inflammatory conditions. A total of 50 patients with definitive bacterial infection or confirmed chronic aseptic inflammatory condition will be enrolled in the trial, according to the Kirkland, Quebec-based vendor.
By AuntMinnie.com staff writersJuly 31, 2003
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