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ANX-530 Demonstrates Equivalent Pharmacokinetics to Navelbine(R) in a Registrational Bioequivalence Clinical Study

al comparison of both the areas under the curve (AUC) and maximum plasma concentrations (Cmax) and was determined based on federal regulations and FDA guidance regarding bioequivalence studies. AUC is a measure of the total amount of the drug circulating in the body over time. Cmax is the maximum concentration of the drug measured in the blood at any given time. If the upper and lower bounds of the AUC ratio's and the Cmax ratio's 90% confidence interval ranged from 0.80 to 1.25, ANX-530 and Navelbine were considered to have equivalent pharmacokinetics. The results of a clinical study are actually estimates of what might be expected if the treatment were to be given to the entire population of interest. Confidence intervals indicate the precision of such an estimate. Pursuant to the study's protocol and statistical analysis plan, data from all 31 patients who received both study drugs were included in the analysis.

A summary of the pharmacokinetic results is set forth in the following table:

Pharmacokinetic Acceptable Range

Parameters ANX-530 Navelbine 90% Confidence Interval

Cmax (ng/mL) 227 223 87-123% 80-125%

AUClast (hrng/mL) 758 717 99-112% 80-125%

AUCinf (hrng/mL) 810 719 100-112% 80-125%

Cmax: Maximum plasma concentration

AUClast: Area under the plasma concentration time curve from time zero to

the last time point

AUCinf: Area under the plasma concentration time curve from time zero to


Both ANX-530 and Navelbine were administered via a 10 minute intravenous injection at a dose of 30 mg/m2. Blood samples for pharmacokinetic analysis were collected prior to the initiation of patient dosing, and, at 10, 20, and 40 minutes after patient dosing, as well as at 1, 3, 6, 24, 48, 72, and 144 hours aft

SOURCE ADVENTRX Pharmaceuticals, Inc.
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