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 (exclude certain Asia-Pacific territories) to CXA-101 (FR264205) from Astellas Pharma Inc. in 2007. CXA-101's potent in vitro activity against Pseudomonas aeruginosa has the potential to address the unmet medical need posed by this very problematic gram-negative pathogen, which is a common cause of serious infection associated with high morbidity and mortality. Nonclinical studies have shown CXA-101 is highly active against multiple drug-resistant Pseudomonas aeruginosa, including many strains resistant to carbapenems, an antibiotic class generally considered as having the most potent activity against resistant gram-negative pathogens.
About Calixa Therapeutics
Calixa Therapeutics Inc. is a biopharmaceutical company committed to the development and commercialization of novel medicines for the treatment of infectious diseases. The company's initial focus is on developing novel antibiotics for use in the hospital setting. Calixa Therapeutics, which is privately held, is headquartered in San Diego and has operations in the San Francisco Bay Area. For additional information, please visit: www.calixainc.com.
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