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ADVENTRX and FDA Reach Agreement on Pivotal Study for ANX-514
Date:10/26/2011

and timing and feasibility of, Study 514-02, the timing of submission of an NDA for ANX-514, the prospects for ultimate approval of an NDA for ANX-514 without clinical studies in addition to Study 514-02, the prospects for elimination of the high-dose corticosteroid premedication required with Taxotere and the potential for ANX-514 to improve the tolerability and safety of docetaxel treatment. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: the risk that ADVENTRX is unable to raise sufficient capital to fund development of its product candidates, including ANX-514; the risk that the primary endpoint in Study 514-02 is not met; the risk that, to demonstrate non-inferiority in Study 514-02, the rate of fluid retention in the ANX-514 arm must be lower than the rate in the Taxotere arm; uncertainty regarding the relative contribution of polysorbate 80 versus docetaxel or other factors on the incidence and severity of fluid retention and other adverse events; uncertainty regarding the impact of removing corticosteroid premedication from the ANX-514 arm on the incidence and severity of adverse events; the risk that, even if ANX-514 meets the primary endpoint in Study 514-02, it may not demonstrate comparable overall safety to Taxotere and, accordingly, may not be sufficient to support an NDA or eliminate corticosteroid premedication without additional clinical studies; the risk that the results of an additional bioequivalence study, if required by FDA, will cause the FDA to require additional nonclinical and/or clinical studies in addition to Study 514-02 prior to the submission or approval of an NDA for ANX-514; the risk that the FDA does not grant market approval of ANX-514 on a timely basis, or at all; the potential for difficulties or delays in completing manufacturing process development activities and manu
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