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Trius Therapeutics To Present Data From Drug Development Programs At ICAAC

SAN FRANCISCO, Sept. 5, 2012 (GLOBE NEWSWIRE) -- ICAAC 2012 -- Trius Therapeutics, Inc. (Nasdaq:TSRX) announced today that the results of multiple studies from its drug development programs, including its lead antibiotic drug candidate tedizolid phosphate (TR-701), will be presented in poster and podium presentations at the 52 nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in San Francisco from September 9 to September 12, 2012.

The presentations contain clinical and nonclinical studies of tedizolid, including results from the ESTABLISH 1 trial. This is the first Phase 3 study of tedizolid in patients with acute bacterial skin and skin structure infections (ABSSSI). Additional preclinical abstracts include advances in Trius' GyrB/ParE antibacterial program, which targets gram-negative pathogens. This is a class of bacteria rapidly developing resistance to existing antibiotics, and for which there are few new antibacterial agents in development.

The presentations are as follows:

Sunday, September 9th

Poster Presentations 010 – Multi-Center Surveillance Studies (11:30 a.m. – 1:30 p.m.)

  • C2-142: In Vitro Activity of Tedizolid and Radezolid against Linezolid-Resistant Gram-positive Clinical Isolates with Genetically Characterized Resistance Mechanisms; E. Cercenado, M. Marín, B. Gama, C. Iglesias, E. Bouza

Monday, September 10th

Poster Presentation 093 – Cornucopia of In Vitro Activity (11:15 a.m. – 1:15 p.m.)

  • E-778: Comparison of Tedizolid (TZD) In Vitro Activity with that of Other Key Gram Positive Agents Against Recent Enterococcal and Streptococcal Isolates; D. Sahm, J. Deane, A. Simenauer, K. Bartizal, K. J. Shaw

Tuesday, September 11th

Poster Presentations 174 – In Vitro Activity Versus Staphylococcal (11:15 a.m. – 1:15 p.m.)

  • E-1479: In Vitro Activity Profile of Tedizolid (TZD) and Correlations with Linezolid (LZD) Activity Against Recent Staphylococcal Isolates; J. Deane, A. Simenauer, K. Bartizal, K. J. Shaw, D. Sahm

Poster Presentations 163 – Pharmacokinetics/Pharmacodynamics of New and Old Oxazolidinones (11:15 a.m. – 1:15 p.m.)

  • A-1291: Study of the Cellular Uptake and Subcellular Distribution of the Oxazolidinone Tedizolid (TZD) in Murine J774 Macrophages: Lack of Association with Mitochondria; D. Das, A. Lambert, P. Tulkens, G. Muccioli, F. Van Bambeke  
  • A-1292: Safety and Pharmacokinetics After Single Oral and IV Administration of Tedizolid Phosphate in Adolescent Patients; H. Dreskin, K.A. Muñoz, S. Minassian, J. Bradley, A. Arrieta, E. Capparelli, R. Jacobs, E. Fang, S. Flanagan, P. Prokocimer  
  • A-1293: Safety and Pharmacokinetics of Single Oral Administration of Tedizolid Phosphate in Healthy Elderly Subjects and Adult Control Subjects; H. Dreskin, D. Subich, K. Muñoz, S. Flanagan, S. Minassian, E. Fang, P. Prokocimer  
  • A-1294: A Phase 1 Study of Intravenously Administered Tedizolid Phosphate in Subjects with Advanced Renal Impairment; S. Flanagan, D. Morris, T. Boyea, H. Dreskin, S. Minassian, H. Alcorn, T. Marbury, M. Abdelhameed, E. Fang, P. Prokocimer  
  • A-1295: A Phase 1 Study of Orally Administered Tedizolid Phosphate in Subjects with Moderate or Severe Hepatic Impairment; S. Flanagan, T. Boyea, H. Dreskin, S. Minassian, T. Marbury, H. Alcorn, E. Fang, P. Prokocimer  
  • A-1295a: Lack of MAO Inhibition by Tedizolid Phosphate in Clinical and Nonclinical Studies; S. Flanagan, S. Minassian, E. Fang, H. Dreskin, R. Weaver, K. Bartizal, P. Prokocimer

Poster Presentations 189 – Novel Agents and Insights in Skin and Soft Tissue Infections (11:15 a.m. – 1:15 p.m.)

  • L1-1664: Safety Profile of Tedizolid Phosphate Compared to Linezolid in a Phase 3 ABSSSI Study; E. Fang, C. De Anda, A. Das, P. Prokocimer  
  • L1-1665: Comparison of Investigator Assessed and Programmatic Clinical Outcomes of Tedizolid Phosphate vs. Linezolid in a Phase 3 Study in Patients with ABSSSI; C. De Anda, E. Fang, S. Green, P. Mehra, P. Prokocimer

Wednesday, September 12th

Poster Presentations 245 – In Vitro Activity for Mycobacteria (9:15 a.m. – 11:15 a.m.)

  • E-1995: In Vitro Activities of Tedizolid Compared to Linezolid against Mycobacterium fortuitum; M. H. Cynamon, M. Sklaney

Poster Presentations 247 – Novel Inhibitors of Bacterial GyrB/ParE Topoisomerase Subunits (9:15 a.m. – 11:15 a.m.)

  • F-2017: Antibacterial Agents Targeting DNA Gyrase B and Topoisomerase IV: Discovery of a New Class by Structure-Based Drug Design; X. Li, L. W. Tari, D. C. Bensen, M. Trzoss, T. Lam, J. Zhang, Z. Chen, S-J. Lee, M. Cunningham, B. Kwan, K. Nelson, M. Stidham, V. Brown-Driver, G. Hough, D. Phillipson, T. Nguyen, F. Lightstone, S. Wong, K. J. Shaw, J. Finn  
  • F-2018: Antibacterial Agents Targeting DNA Gyrase B and Topoisomerase IV: Optimization of Gram-Negative Antibacterial Activity and Drug Properties; J. Finn, M. Trzoss, X. Li, D. C. Bensen, T. Lam, J. Zhang, Z. Chen, S-J. Lee, M. Cunningham, K. Nelson, A. Castellano, B. Kwan, M. Stidham, V. Brown-Driver, T. Nguyen, F. Lightstone, S. Wong, K. J. Shaw, L. Tari  
  • F-2018a: Antibacterial Agents Targeting DNA Gyrase B and Topoisomerase IV: Design of Compounds with Broad-Spectrum Gram-Negative Antibacterial Activity; L. W. Tari, X. Li, D. C. Bensen, M. Trzoss, T. Lam, J. Zhang, Z. Chen, S-J. Lee, M. Cunningham, K. Nelson, M. Stidham, V. Brown-Driver, B. Kwan, S. Rodriguez, T. Nguyen, F. Lightstone, S. Wong, K. J. Shaw, J. Finn  
  • F-2019: Potent Activity of Novel Gyrase/Topoisomerase Inhibitors Against Gram-Negative and Gram-Positive Pathogens with Important Resistance Phenotypes; C. M. Pillar, L. Stapert, M. A. Marchak, D. L. Shinabarger  
  • F-2020: Microbiological Profile of Novel Inhibitors of DNA Gyrase and Topoisomerase IV Against Gram-Negative Pathogens; K. Nelson, A. Castellano, S. Farkas, V. Brown-Driver, K. J. Shaw  
  • F-2021: In Vitro Activity of Novel Gyrase Inhibitor Antimicrobials Against Clinical Pseudomonas aeruginosa Isolates; P. R. Tessier, D. Nicolau  
  • F-2022: Antimicrobial Activity and in vivo Efficacy of Novel GyrB/ParE Inhibitors versus Burkholderia pseudomallei; V. Brown-Driver, R. Bowen, N. L. Podnecky, N. Marlenee, X. Li, K. J. Shaw, H. P. Schweizer  
  • F-2023: Broad Spectrum Activity of Novel, Dual Targeting Inhibitors of Bacterial DNA Gyrase and Topoisomerase IV Against Biodefense Pathogens; V. Brown-Driver, K. Montgomery, G. Vanier, K. Nelson, K. J. Shaw, P. J. Jackson  
  • F-2024: Advanced Microbiological Profile of New DNA Gyrase/Topoisomerase IV Inhibitors; V. Brown-Driver, A. Castellano, K. Nelson, X. Li, T. Lam, M. Trzoss, J. Zhang, Z. Chen, S. Lee, K. J. Shaw, J. Finn  
  • F-2025: Selection and Characterization of E. coli Mutants with Reduced Susceptibility to Novel DNA Gyrase/Topoisomerase IV Inhibitors; J. Locke, A. Castellano, S. Farkas, V. Brown-Driver, K. J. Shaw  
  • F-2026: Comparative Pharmacokinetics of Novel Inhibitors of DNA Gyrase/Topoisomerase IV; V. S. Ong, V. Brown-Driver, C. L. Hall, G. W. Hough, K. Nelson, M. Cunningham  
  • F-2027: Use of Microdosing and Accelerator Mass Spectrometry to Evaluate the Pharmacokinetics of a Novel GyrB/ParE Inhibitor; M. A. Malfatti, V. Lao, K. W. Turteltaub, C. L. Hall, V. S. Ong  
  • F-2028: Activity of Novel, Dual Targeting Inhibitors of Bacterial DNA Gyrase and Topoisomerase IV in Murine Infection Models; T. M. Murphy, M. A. Blair, S. Little, A. Taylor, A. Slee, V. Brown-Driver, K. J. Shaw  
  • F-2029 In Vitro Activity and Pharmacodynamic (PD) evaluation of Dual Targeting Inhibitors of Bacterial DNA Gyrase and Topoisomerase IV (DTIs) against Extracellular and Intracellular Forms of ciprofloxacin-susceptible (CIPS) and ciprofloxacin-resistant (CIPR) Pseudomonas aeruginosa (PA) and Staphylococcus aureus (SA); P. M. Tulkens, S. Lemaire, D. Pierard, F. Van Bambeke

Symposium 228 – Cfr-Mediated Resistance to Linezolid and Other Antibiotics (9:15 a.m. – 9:45 a.m.)

Copies of these posters will be available on the Trius website following the ICAAC meeting: http://www.triusrx.com/trius-therapeutics-news-posters-publications-year.php .  

About Trius Therapeutics

Trius Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for life-threatening infections. The Company's lead investigational drug, tedizolid phosphate, is a once daily, IV and orally administered second generation oxazolidinone in Phase 3 clinical development for the treatment of acute bacterial skin and skin structure infections, or ABSSSI. Trius has two Special Protocol Assessments with the FDA for its two Phase 3 ABSSSI trials and has partnered with Bayer HealthCare for the development and commercialization of tedizolid phosphate outside of the U.S., Canada and the European Union. In addition to the Company's tedizolid phosphate clinical program, Trius has initiated IND-enabling studies for its Gyrase-B development candidate with potent activity against Gram-negative bacterial pathogens including multi-drug resistant strains of E. coli, Klebsiella, Acinetobacter and Pseudomonas. The Gyrase-B program is one of the two preclinical programs supported by federal contracts. For more information, visit www.triusrx.com .

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trius' ability to meet its future financing needs and successfully complete its ongoing clinical trials and development programs and transition into commercialization. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Trius' estimates regarding expenses, future revenues and capital requirements; the success and timing of Trius' preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Trius' plans to develop and commercialize its product candidates; Trius' ability to obtain additional financing; Trius' ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Trius' most recently filed SEC documents, including its Form 10-K, Forms 10-Q and other documents filed with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trius undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT: Media Contacts:
         Laura Kempke/Andrew Law
         MSLGROUP
         781-684-0770
         trius@mslgroup.com
         
         Investor Relations Contact:
         Stefan Loren
         Westwicke Partners, LLC
         443-213-0507
         sloren@westwicke.com

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