ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clin...(and Navelbine. Determining thesafety of ...),Health

Date:11/16/2007

and Navelbine. Determining the safety of a single dose of ANX-530 was a secondary objective. In the first week, patients were dosed with either ANX-530 or Navelbine, and after a washout period, were dosed with the opposite drug during the second week of treatment. The FDA has indicated that this single clinical study, should it demonstrate pharmacokinetic equivalence between ANX-530 and Navelbine, would provide sufficient clinical data to support a Section 505(b)(2) NDA.

Pharmacokinetic equivalence was determined based on federal regulations and FDA guidance regarding bioequivalence studies. 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. 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. 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.

About ANX-530 (vinorelbine emulsion)

ANX-530 is a novel emulsion formulation of vinorelbine tartrate, a generic chemotherapy agent. ANX-530 is designed to reduce the incidence and severity of vein irritation from intravenous-delivery of vinorelbine tartrate. Vinorelbine tartrate works by disrupting microtubule formation and is a member of the vinca alkaloid class of antineoplastic agents. Vinorelbine is indicated as a single agent or in combination with cisplatin for treatment of advanced non-small cell lung cancer and has also shown activity in breast, ovarian, and other cancers.

About Section 505(b)(2)

Section 505(b)(2) of the
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SOURCE ADVENTRX Pharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

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