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ADVENTRX Announces Results From ANX-514 Bioequivalence Study
Date:5/7/2009

- Updates guidance regarding strategic transaction process

SAN DIEGO, May 7 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced results from its bioequivalence study of ANX-514 (docetaxel emulsion). ANX-514 was determined to have comparable overall safety as Taxotere(R), the reference product, with no differences between treatment groups in severe toxicities. However, pharmacokinetic equivalence, the primary endpoint of the study, was not demonstrated based on benchmark regulatory standards.

"Following discussions with clinicians and experts in taxane pharmacokinetics, we believe that the increased blood-levels of docetaxel, which we observed solely during the first hour of a 168-hour observation period, do not affect the safety or efficacy of the drug and are not clinically relevant, and that our pharmacokinetic data should be sufficient to support an NDA for ANX-514," said Brian M. Culley, Chief Business Officer of ADVENTRX. "In addition, we have not fully investigated whether variability with respect to study drug administration and/or blood sample collection may have affected the results. However, the FDA is the final arbiter of safety and efficacy and, following discussion with the Agency, we will have more insight into whether additional pre-clinical and/or clinical activities may be necessary before submitting an NDA for ANX-514."

"The possibility of additional activities creates uncertainty around the cost and timeline to FDA approval of ANX-514, which may adversely impact our on-going strategic transaction discussions," Mr. Culley continued. "Consequently, and in light of our current working capital, we are evaluating both our strategic and non-strategic options."

The study data revealed higher blood-levels of docetaxel during and immediate
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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