Recent Updates
Recently added Catalysts

Aurexis

Phase 2

Staphylococcus Aureus | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Mar 29, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Aurexis · 2 trials · 2 indications

Phase 2 2
NCT00198289Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their LungsStaphylococcus Aureus
COMPLETED30 Analytics
NCT00198302Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)Staphylococcus Aureus Bacteremia
COMPLETED60 Analytics
PHASE2COMPLETED
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Staphylococcus Aureus
NCT0019828930
Unlock trial analytics
PHASE2COMPLETED
Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)
Staphylococcus Aureus Bacteremia
NCT0019830260
Unlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
To evaluate the pharmacokinetics of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
• To evaluate the safety of standard of care, plus a single dose of Aurexis® compared to a single dose of placebo, in subjects with documented SAB
• To evaluate the pharmacokinetics of a single dose of Aurexis® in combination with standard of care in the subjects with SAB
• To evaluate the activity of a single dose of Aurexis® in combination with standard of care, as measured by:
o number of subjects with uncomplicated SAB at baseline who progress to complicated SAB
o number of subjects with microbiologically documented relapse of SAB
o mortality rates

Secondary Endpoints

To evaluate the biologic and clinical effects of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs on:
Changes in bacterial load of SA in sputum as determined by colony counts
Changes in inflammatory mediators in nasal lavage fluid, breath condensate and plasma, including IL-1β, IL-6, IL-8, and TNFα.
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Interventions

NameTypeDescription
Aurexis® (tefibazumab)DRUG -
Aurexis®DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range7 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Aurexis

What is Aurexis used for?

Aurexis is an investigational small molecule being studied for the treatment of Staphylococcus aureus infections, including Staphylococcus aureus bacteremia (SAB). It has been evaluated in patients with cystic fibrosis who are chronically colonized with Staphylococcus aureus in their lungs.

Who makes Aurexis?

Aurexis is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the stock exchange.

What phase is Aurexis in?

Aurexis is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, but it is not yet available as a marketed therapy.

What clinical trials is Aurexis in?

Aurexis has been studied in two completed Phase 2 trials. NCT00198289 evaluated Aurexis in cystic fibrosis subjects chronically colonized with Staphylococcus aureus in their lungs. NCT00198302 compared standard antibiotic therapy plus Aurexis or placebo for the treatment of Staphylococcus aureus bacteremia.

Is Aurexis the same as tefibazumab?

Aurexis is also known by the name tefibazumab. Both names refer to the same investigational drug being developed by Bristol-Myers Squibb for Staphylococcus aureus infections.