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Calixa Therapeutics to Make Multiple Presentations on CXA-101 and CXA-101/tazobactam at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

Thursday, September 17, 2009 General News J E 4
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SAN DIEGO, Sept. 11 Calixa Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel antibiotics for the treatment of antibiotic-resistant infections, will present pre-clinical and clinical data in 20 posters at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) that is being held in San Francisco on September 12 to 15, 2009. The presentations will include comprehensive in vitro, in vivo, and clinical data on Calixa's anti-pseudomonal cephalosporin, CXA-101, alone and in combination with the beta-lactamase inhibitor, tazobactam.

CXA-101 is a potent, intravenously administered, anti-pseudomonal cephalosporin currently in Phase 2 study for the treatment of complicated urinary tract infections. Calixa recently initiated a Phase 1 study in healthy subjects for a second product, CXA-101/tazobactam. Tazobactam is a well established beta-lactamase inhibitor that could further enhance the excellent antibacterial activity of CXA-101 and potentially increase its clinical utility.

"This is an outstanding achievement for Calixa," said James Ge, M.D., Ph.D., chief scientific officer and executive vice president, of Calixa. "The 20 presentations give us a very strong presence at this major infectious disease conference, and reflect significant progress over the past year. We are particularly enthusiastic about the excellent clinical safety and pharmacokinetics profile CXA-101 exhibited in the Phase 1 studies conducted to date. We look forward to moving this promising compound, alone and in combination with tazobactam, to the next stages of clinical development."

The 20 presentations (F1-1985 to F1- 2004) relating to Calixa's antibiotic compounds will be presented in the Poster Session, Investigational Cephalosporins (Tuesday, September 15, 2009, 9:00 to 11:00 AM PDT). The titles of the presentations are as follows:

F1-1985: Affinity of the New Cephalosporin CXA-101 to Penicillin-Binding Proteins of Pseudomonas aeruginosa

F1-1986: Activity Profile of CXA-101 and CXA-101/Tazobactam against Target Gram-Positive and Gram-Negative Pathogens

F1-1987: Activity of the New Cephalosporin CXA-101 against Carbapenem-Resistant Pseudomonas aeruginosa Isolates from a Spanish Multicenter Study

F1-1988: CXA-101 has High Activity against Clinical Isolates of Pseudomonas aeruginosa Including Ceftazidime-Resistant Isolates

F1-1989: Activity of CXA-101 against Pseudomonas aeruginosa beta-lactam Resistance Mechanisms: ampD, ampDh2, ampDh3, dacB (PBP4), and oprD Mutations

F1-1990: Activity of the New Cephalosporin CXA-101 against Biofilms of Relevant P. aeruginosa Phenotypes in Cystic Fibrosis Chronic Respiratory Infection: Mucoid and Hypermutable Strains

F1-1991: Activity of the New Cephalosporin CXA-101 against Biofilms of Relevant P. aeruginosa Phenotypes in Cystic Fibrosis Chronic Respiratory Infection: Mucoid and Hypermutable Strains

F1-1992: Activity of the Novel Cephalosporin CXA-101 Tested in Combination with Tazobactam against Cephalosporin-resistant Enterobacteriaceae, P. aeruginosa and B. fragilis

F1-1993: Activity of CXA-101 plus Tazobactam against ESBL-Producing Escherichia coli and Klebsiella pneumoniae

F1-1994: Chequerboard Titrations of Cephalosporin CXA-101 (FR264205) and Tazobactam vs. Beta-lactamase-producing Enterobacteriaceae

F1-1995: FIC Index Determination of CXA-101/Tazobactam in Combination with Amikacin, Aztreonam, Meropenem, Levofloxacin, and Tigecycline against E. coli, K. pneumoniae, and P. aeruginosa Strains.

F1-1996: In Vitro Assessment Using Time-kill Curves of CXA-101 (CXA)/Tazobactam (TAZ) Against Escherichia coli (EC), Klebsiella pneumoniae (KP), and Pseudomonas aeruginosa (PA) Strains

F1-1997: Quality Control Parameters for CXA-101 Broth Microdilution Susceptibility Tests

F1-1998: Disk Diffusion Testing of CXA-101 and CXA-101 in Combination with Tazobactam against Target Pathogens

F1-1999: In Vivo Activity of CXA-101 plus a 2:1, 4:1, or 8:1 Ratio of Tazobactam against Various Enterobacteriaceae Producing Extended-Spectrum Beta-Lactamases in the Thighs of Neutropenic Mice

F1-2000: 50% Effective Dose Determination of CXA-101 Alone or in Combination with Tazobactam for Treating Experimental Peritonitis in Mice Due to ESBL-Producing Escherichia coli strains: Comparison with Ceftazidime and Piperacillin/Tazobactam

F1-2001: Pharmacokinetics Study of CXA-101 (CXA) in Combination with Tazobactam in Dogs after Intravenous Administration

F1-2002: In Vivo Activity of CXA-101, a New Cephalosporin, against Pseudomonas aeruginosa and other Enterobacteriaceae in the Thighs of Neutropenic Mice

F1-2003: CXA-101 Population PK Analysis and Monte Carlo Simulation for PK/PD Target Attainment and Dose Regimen Selection

F1-2004: The Pharmacokinetics and Safety of CXA-101, a New Anti-pseudomonal Cephalosporin, in Healthy Adult Male and Female Subjects Receiving Single- and Multiple-Dose Intravenous Infusions

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.

Contacts: Robert Flamm, Ph.D., or David Schull Russo Partners (212) 845-4226 robert.flamm@russopartnersllc.com david.schull@russopartnersllc.com Eckard Weber, M.D. Calixa Therapeutics Inc. (858) 480-2420 stone@domainvc.com

SOURCE Calixa Therapeutics Inc.
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