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ADVENTRX Announces Positive Data From Preclinical Pharmacokinetic,Testing of ANX-514 (Docetaxel Emulsion)

tere induced an anaphylactoid type reaction consistent with hypersensitivity reactions, including acute increases in blood histamine levels and decreased blood pressure. In contrast, no hypersensitivity reactions, including no elevations in histamine levels and no changes in blood pressure were observed following dosing with ANX-514.

ADVENTRX is continuing to conduct additional preclinical pharmacokinetic testing of ANX-514 to compare this product candidate with the approved version of the product, marketed under the brand name Taxotere. The Company currently plans to seek guidance from the FDA with respect to the appropriateness of a Section 505(b)(2) NDA regulatory path for ANX-514, and pending agreement on clinical protocol design with the FDA, initiate a marketing-enabling clinical trial of ANX-514 in 2007.

About ANX-514 (docetaxel emulsion)

ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, a product marketed under the brand name Taxotere. ANX-514 is designed to eliminate the need for multi-day immunosuppressant premedication. 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 allergic reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers. In connection with a Section 505(b)(2) NDA covering ANX-514, ADVENTRX must certify that all applicable Taxotere patents have expired prior to the manufacture, use or sale of ANX-514.

About Section 505(b)(2)

Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows the Food and Drug Administration (FDA) to approve a follow-on drug on the basis of data in
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