Novexel’s NXL104/ceftazidime Combination Commences Phase II Clinical Trial
Novexe announced that its most advanced injectable antibacterial, which combines Novexel’s broad spectrum beta-lactamase inhibitor, NXL104, with the well established cephalosporin antibiotic, ceftazidime, has entered Phase II clinical trials.
The initial Phase II trial with NXL104/ceftazidime will be in hospitalized patients with complicated urinary tract infections (cUTIs). NXL104/ceftazidime is being developed to treat hospital infections that are caused by Gram negative bacteria, including those resistant to many currently used antibiotics.
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 vs. imipenem cilastatin (Primaxin® or Tienam®, Merck & Co. Inc., NYSE: MRK) in the treatment of adults with cUTIs. Complicated urinary tract infections include acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign bodies, or urologic abnormalities. 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 4 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 7 to 14 days. The results of this study are expected in late 2009.
In completed Phase I studies in healthy subjects NXL104/ceftazidime was generally well tolerated and the pharmacokinetics of the two components were well matched. Additional studies in special populations are ongoing.
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