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Calixa Therapeutics Announces Positive Phase 1 Results for CXA-101, a Novel Intravenous Cephalosporin Antibiotic with Excellent Anti-Pseudomonal Activity
Date:3/23/2009

SAN DIEGO, March 24 /PRNewswire/ -- Calixa Therapeutics Inc. today announced positive results from a Phase 1 trial of intravenous CXA-101, a novel cephalosporin antibiotic with excellent in vitro anti-pseudomonal activity.

The results from this first Phase 1 study demonstrated that CXA-101 was well tolerated, with a clinical and laboratory safety profile similar to that of marketed cephalosporin antibiotics. No dose-limiting toxicity was observed, even at the highest dose regimen evaluated. In addition, CXA-101 demonstrated predictable, linear pharmacokinetics after intravenous administration in humans. The results of this study fully support the further clinical development of this compound.

"Pseudomonas aeruginosa is usually less susceptible to commonly used antibiotics, and infections caused by this organism are often severe and very difficult to treat," said Ian Friedland, M.D., chief medical officer of Calixa Therapeutics. "There is a need for a safe and efficacious antibiotic to treat pseudomonal infections. Unfortunately, the pipeline for such drugs is virtually empty. The promising results in Phase 1 will enable us to quickly advance CXA-101 into Phase 2 to evaluate its safety and efficacy in patients."

The completed Phase 1 trial was designed as a single- and multiple-ascending dose study to assess the safety, tolerability and pharmacokinetic profile of the compound in healthy volunteers. The study was successfully conducted in the U.S. under an IND.

"Our development program is progressing well with our team that has a proven track record in the anti-infective field," said Eckard Weber, M.D., CEO and president of Calixa Therapeutics. "The Phase 1 data suggest a well-tolerated drug with an excellent profile for potential clinical use as a treatment of gram-negative bacterial infections."

Calixa Therapeutics acquired the global development rights
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SOURCE Calixa Therapeutics Inc.
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