SAN DIEGO, June 30 /PRNewswire/ -- Calixa Therapeutics Inc. today announced the initiation of a Phase 2 clinical trial of CXA-101 in patients with complicated urinary tract infections. CXA-101 is a new broad-spectrum, parenteral cephalosporin antibiotic with excellent in vitro and in vivo activity against Pseudomonas aeruginosa, including drug resistant isolates. Calixa is investigating CXA-101 as a potential treatment for serious bacterial infections in hospitalized patients.
The multi-center, randomized study is anticipated to enroll approximately 120 patients and will compare the efficacy and safety of CXA-101 with the current standard of therapy. The primary efficacy endpoint for this study is microbiological outcome at the test-of-cure visit between six to nine days after the end of therapy.
"The preclinical and Phase 1 results to date are very promising and indicate that CXA-101 is well tolerated and has broad-spectrum antibacterial coverage, including potent activity against increasingly resistant gram-negative pathogens such as Pseudomonas aeruginosa," said Dr. Ian Friedland, chief medical officer of Calixa. "We are going to present comprehensive preclinical and Phase 1 data at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy in September and other medical conferences. This Phase 2 study will generate important information on the safety and effectiveness of CXA-101 in complicated urinary tract infections, which are usually caused by gram-negative pathogens".
Eckard Weber, president and chief executive officer of Calixa and partner at the venture capital firm Domain Associates, LLC said, "With the continually increasing incidence of serious and life-threatening infections caused by resistant gram-negative bacteria and the paucity of new drugs in the pipeline to counter such resistance, we are working diligently to expedite the development of CXA-101. We are fully committed to providing patients and physicians with a much needed option for the treatment of life-threatening infections caused by gram-negative bacteria."
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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