Adventrx Pharmaceuticals, Inc. announced positive results from its marketing-enabling clinical study of ANX-530 (vinorelbine emulsion). Pharmacokinetic equivalence, the primary endpoint of the study, was observed between ANX-530 and Navelbine, the reference product, in patients with advanced cancer potentially sensitive to vinorelbine.

Equivalence was demonstrated by a statistical comparison of both the areas under the curve (AUC) and maximum plasma concentrations (Cmax). The company anticipates safety and full clinical results will be available during the first quarter of 2008..

"We're very pleased with these results, which we believe will provide sufficient clinical data to support a Section 505(b)(2) New Drug Application," said Evan M. Levine, chief executive officer, Adventrx. "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."

ANX-530 is a novel emulsion formulation of vinorelbine. Vinorelbine, marketed under the brand name Navelbine, also available as generic vinorelbine, is an anti-cancer agent approved to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin. Worldwide annual sales of Navelbine and generic vinorelbine in 2006 were approximately $200 million.

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. 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 per cent 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.

ANX-530 (vinorelbine emulsion)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.

Adventrx Pharmaceuticals is a biopharmaceutical research and development company focused on commercialising proprietary product candidates for the treatment of cancer and infectious diseases. The company seeks to improve the performance and safety of existing treatments by addressing significant problems such as drug metabolism, bioavailability, excessive toxicity and treatment resistance.