Adventrx reports positive safety data from bioequivalence study

In addition, in post hoc analyses, ANX-530 demonstrated a statistically significant reduction in injection site reactions when compared to Navelbine (p<0.01). ANX-530 was determined generally to be safe and well-tolerated. Adventrx intends to submit to the FDA a Section 505(b)(2) NDA for ANX-530 around the end of 2008. 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. Pharmacokinetic equivalence, the primary endpoint of the study, was observed between ANX-530 and Navelbine. Evan Levine, CEO and president of Adventrx, said: "The improvement in injection site reactions could translate into a real benefit for patients as well as healthcare practitioners."