The bioequivalence study of ANX-530 was a crossover comparison of ANX-530 and Navelbine with a primary objective of demonstrating the pharmacokinetic equivalence of ANX-530 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.
Equivalence was demonstrated by a statistical comparison of both the areas under the curve (AUC) and maximum plasma concentrations (Cmax). 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 company anticipates safety and full clinical results will be available during the first quarter of 2008.
ANX-530 is a novel emulsion formulation of vinorelbine. Vinorelbine, marketed under the brand name Navelbine, is an anti-cancer agent approved to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin.
Evan Levine, CEO of Adventrx, said: “We’re very pleased with these results, which we believe will provide sufficient clinical data to support a new drug application. We have a meeting scheduled with the FDA in December to discuss our commercial manufacturing plans. After we receive the FDA’s written comments, we intend to provide an update regarding our NDA timeline for ANX-530.”