ANX-514 Reduces Hypersensitivity Reactions Without Impacting Pharmacokinetics or Antitumor Activity in Preclin...(essureand increases in histamine levels ...)

Date:10/25/2007

essure and increases in histamine levels were observed within 10-20 minutes of Taxotere administration. In contrast, hypersensitivity reactions were not observed following administration of ANX-514; specifically, no treatment-related change in blood pressure and no increase in histamine levels were observed. In this crossover design study, even on re-challenge at 3 weeks, hypersensitivity reactions were observed only in the Taxotere treated animals. In two separate studies in different animal species, ANX-514 showed bioequivalent pharmacokinetics to Taxotere. Moreover, in an established in vivo model, ANX-514 demonstrated dose-dependent inhibition of tumor growth with equivalent antitumor activity when compared to Taxotere at equal dose levels.

A copy of the poster presentation is available for download from the "Resources" section of the Company's web site at http://www.adventrx.com under "Publications".

About ANX-514 (docetaxel emulsion)

ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, which is marketed under the brand name Taxotere. ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and/or incidence of hypersensitivity reactions. Docetaxel is an anti-cancer agent that acts by disrupting the cellular microtubular network that is essential for cell division. Immunosuppressant premedication is recommended for docetaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.

ADVENTRX recently received confirmation from the U.S. Food and Drug Administration (FDA) regarding its proposed 505(b)(2) New Drug Application (NDA) regulatory plan for ANX-514. The FDA indicated that data from a single study of approximately 28 patients that demonstrates the bioequivalence of ANX-514 and Taxotere i
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SOURCE ADVENTRX Pharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

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