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

Results Indicate Bioequivalent Pharmacokinetics With Reduced Risk of Hypersensitivity Reactions With ANX-514

SAN DIEGO, April 25, 2007 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. , a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, today announced positive results from preclinical pharmacokinetic testing of ANX-514 (docetaxel emulsion) in a well recognized animal model. The study results indicate bioequivalent pharmacokinetics between ANX-514 and the FDA-approved version of docetaxel, marketed under the brand name Taxotere(R). Furthermore, ANX-514, administered intravenously, did not cause hypersensitivity reactions in this study, as opposed to acute hypersensivity reactions observed following intravenous treatment with Taxotere. ANX-514 is a novel emulsion formulation of docetaxel, an agent for the treatment of breast, non-small cell lung, prostate and gastric cancers.

"These preclinical results are important and strengthen our belief that ANX-514 is an appropriate candidate for marketing approval under the shorter timelines available under Section 505(b)(2)," said Evan M. Levine, chief executive officer for ADVENTRX. "In addition, these results suggest that treatment with ANX-514 may eliminate the need for multi-day premedication with corticosteroids prior to treatment, which is currently recommended prior to treatment with Taxotere."

In this study, docetaxel concentration in plasma was sequentially measured over 24 hours following intravenous injections with either ANX-514 or Taxotere. Pharmacokinetic analysis indicated no statistically significant (p < 0.05) differences in docetaxel maximum concentration (Cmax) or area under the curve (AUC) between ANX-514 and Taxotere. In addition, less toxicity was observed following dosing with ANX-514 than dosing with Taxotere. Taxo
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