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Also known as Aurexis® (tefibazumab)
Aurexis · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| Aurexis® (tefibazumab) | DRUG | - |
| Aurexis® | DRUG | - |
Inclusion Criteria: * Male or female, ages \> 7 years old * Diagnosis of CF as evidenced by sweat chloride test and/or genetic mutation testing * Sputum SA CFUs \> 10,000 per mL * Ability to expectorate sputum * Ability to tolerate nasal lavage and collection of breath condensate * Willi...
Aurexis is an investigational monoclonal antibody being studied for Staphylococcus aureus infections, including Staphylococcus aureus bacteremia. It has been evaluated in Phase 2 clinical trials in patients with S. aureus bacteremia and in cystic fibrosis patients chronically colonized with Staphylococcus aureus in their lungs. It is not approved for commercial use.
Aurexis is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the clinical trials evaluating Aurexis in Staphylococcus aureus infections.
Aurexis is in Phase 2 clinical development. It has completed Phase 2 trials in Staphylococcus aureus bacteremia and in cystic fibrosis patients colonized with Staphylococcus aureus. It remains an investigational agent and has not been approved by the FDA.
Aurexis has been studied in two completed Phase 2 trials. NCT00198302 compared standard antibiotic therapy plus Aurexis or placebo in Staphylococcus aureus bacteremia, enrolling 60 patients. NCT00198289 evaluated Aurexis in cystic fibrosis patients chronically colonized with Staphylococcus aureus in their lungs, enrolling 30 patients in the United States.
Yes, Aurexis is also known as tefibazumab. Aurexis (tefibazumab) is the same monoclonal antibody product, and the names are used interchangeably in reference to the same investigational therapy for Staphylococcus aureus infections.
Aurexis is a monoclonal antibody. It is designed to target Staphylococcus aureus, the bacterium that causes the infections studied in its clinical program, including Staphylococcus aureus bacteremia. The specific molecular target of the antibody is not further specified in the available program information.