ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clin...( SAN DIEGO Nov. 16 /- ADVENTRX Pha...),Health

SAN DIEGO, Nov. 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today 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(R), 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. Results from this study will be submitted for presentation at an appropriate medical conference.

"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 of 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(R), 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
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