Navigation Links
Calixa Therapeutics Announces Positive Phase 1 Results for CXA-101, a Novel Intravenous Cephalosporin Antibiotic with Excellent Anti-Pseudomonal Activity

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:


    Robert Flamm, Ph.D., or David Schull
    Russo Partners
    (212) 845-4226

    Eckard Weber, M.D.
    Calixa Therapeutics Inc.
    (858) 480-2420

SOURCE Calixa Therapeutics Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A.
2. Alba Therapeutics Corporation Announces the Next Clinical Trial of Its Lead Compound, Larazotide Acetate and Promotions
3. InteKrin Therapeutics Announces Enrollment Completion of 360 Patient, 24 week Phase 2b Study
4. Ascenta Therapeutics Announces Positive Preliminary Results with AT-101 in Docetaxel Refractory Prostate Cancer
5. Amicus Therapeutics Suspends Enrollment for Phase 2 Clinical Trial of AT2220 for Pompe Disease
6. ExonHit Therapeutics Reports Advancements in the Clinical Development of EHT 0202, its Phase II Drug for Alzheimers Disease
7. BN ImmunoTherapeutics Updates on Phase I/II Studies With Breast Cancer Vaccine
8. Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone
9. Cerenis Therapeutics In-Licenses Intellectual Property for New Treatment of Aortic Valve Stenosis
10. PTC Therapeutics Completes Enrollment of Pivotal Trial in Muscular Dystrophy
11. DNA Therapeutics Closes 2.2 Million EUR Series A Financing Round
Post Your Comments:
(Date:12/1/2015)... FREMONT, Calif. , Dec. 1, 2015 ... identify the Top 10 Clinical Data Management Solution ... of entries, a distinguished panel comprising CEOs, CIOs, VCs, ... Velos in the illustrious list of top 10 clinical ... and the article on pages 14 and 36 respectively). ...
(Date:12/1/2015)... 1, 2015 Assurex Health, Inc. today ... giving healthcare providers an expanded range of options ... suffering from depression, anxiety, bipolar disorder, posttraumatic stress ... i .   --> ... the addition of two new drug classes, 17 ...
(Date:12/1/2015)... VERONA, Va. , Dec. 1, 2015 /PRNewswire/ ... today unveiled a new corporate logo and brand ... in the design and engineering of bladed products ... --> --> Serving ... fiber, glass, and auto glass equipment, AccuTEC,s product ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 02, 2015 , ... The National Association of ... into its VIP Woman of the Year Circle. She is recognized with this ... exclusively for professional women, boasting 850,000 members and, over 200 operating Local Chapters. ...
(Date:12/1/2015)... ... 01, 2015 , ... Trustify is proud to announce the success of the ... an organization dedicated to ending domestic violence. , Trustify and Becky’s Fund have joined ... survivors of domestic violence. Trustify is also proud to announce the launch of the ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... The Multiple ... drive awareness and funds for Multiple System Atrophy (MSA) research, timed today to coincide ... takes many things from patients including their ability to work and be productive, to ...
(Date:12/1/2015)... ... 2015 , ... World Patent Marketing , a vertically integrated manufacturer ... for easier packing and organizing of items into one big, portable jar. , The ... CEO and Creative Director of World Patent Marketing and Desa Industries Inc . ...
(Date:12/1/2015)... ... December 02, 2015 , ... ClinicoEconomics and Outcomes Research ... of treatment for osteoporosis ”. , As corresponding author Dr Ankita Modi says ... with osteoporosis. Based on a large US managed care database, women aged 55 ...
Breaking Medicine News(10 mins):