Novexel Initiates Phase II Urinary Tract Infections Trial
Novexel, a specialty pharmaceutical company, has initiated Phase II clinical trial of its advanced injectable antibacterial, which combines the company’s broad spectrum beta-lactamase inhibitor, NXL104, with cephalosporin antibiotic, ceftazidime.
This Phase II trial is a prospective, multicenter, investigator-blinded, randomized study which is designed to evaluate the efficacy, safety, and tolerability of NXL104/ceftazidime versus imipenem cilastatin (Primaxin or Tienam, Merck & Co) in the treatment of adults with complicated urinary tract infections (cUTIs). A total of approximately 150 patients will be enrolled, with 75 patients being included in each treatment arm.
The primary objective of the study is to evaluate the microbiological response to NXL104/ceftazidime in the treatment of adult patients with cUTIs as compared to imipenem/cilastatin. This evaluation will be based on the test of cure visit five to nine days post-therapy.
After at least four days of IV antibiotic therapy, patients may be switched to oral ciprofloxacin, if they meet protocol-defined criteria. The total duration of antibiotic therapy for each patient should be seven to 14 days. The results of this study are expected in late 2009.
Iain Buchanan, Novexel’s CEO, said: “We continue to believe that this novel combination, which is based around our novel beta-lactamase inhibitor, NXL104, has the potential to play an important role in confronting the increasing problem of hospital infections caused by resistant Gram negative bacteria. The start of our first Phase II study with NXL104 in combination with ceftazidime is an important milestone for the company.”