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美國Calixa Therapeutics 
Calixa Therapeutics, Inc. is a privately-held biopharmaceutical company focused on the development of a novel cephalosporin to address the expanding problem of multi-drug resistant organisms. Treatment of infections caused by resistant gram-negative bacteria, especially Pseudomonas aeruginosa, is recognized as an unmet medical need by the infectious diseases community.
Calixa’s lead product, CXA-101, is an IV formulation of a novel cephalosporin that has excellent potency especially against multi-drug resistant Pseudomonas aeruginosa, which differentiates it from other cephalosporins. No similar drug is known to be in development. Calixa plans to combine this product with a β-lactamase inhibitor; the combination product (CXA-201) has the potential to become the first-line therapeutic choice for hospitalized patients suffering from serious infection caused by gram-negative organisms.
DEVELOPMENT STATUSThe IND for CXA-101 was filed in June 2008, and two Phase 1 studies were successfully completed by January 2009. The safety and pharmacokinetic profile of CXA-101 was excellent. A Phase 2 study in complicated urinary tract infection was initiated in the second quarter of 2009. The development pathway of CXA-101 will be merged with the development of CXA-201, the combination of CXA-101 and a β-lactamase inhibitor. CXA-201 has an enhanced spectrum of activity and therefore high potential clinical utility as first-line therapy for serious gram-negative infection in hospitalized patients. In addition to the IV products, the same cephalosporin is being evaluated for inhaled administration (the CXA-301 program) in cystic fibrosis patients to address multi-drug resistance (including to tobramycin) in Pseudomonas aeruginosa infections.
HISTORYCalixa was cofounded in 2007 by Drs. Eckard Weber and James Ge. Calixa successfully acquired the global (excluding certain Asia-Pacific territories) development rights for FR264205 from Astellas Pharma Inc. Calixa quickly assembled a management team with extensive recent experience in the clinical development of anti-infectives. We raised a $30 million Series A round from three highly respected venture capital firms: Domain Associates, Canaan Partners and Frazier Healthcare Ventures.