The study is a multi-center, open-label, randomized two-period crossover comparison of ANX-514 and Taxotere, with a primary endpoint of pharmacokinetic equivalence of ANX-514 and Taxotere and a goal of 28 evaluable patients. The safety of a single dose of ANX-514 is being evaluated as a secondary endpoint.
The FDA has indicated that this single study, should it demonstrate bioequivalence between ANX-514 and Taxotere, would provide sufficient human data to support the submission of a new drug application.
The company said that it is on track to announce results from this study in the second quarter of 2009.
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates primarily for the treatment of cancer. In December 2008, the Company announced that it is exploring a range of strategic options, including the sale or disposition of one or more of its product candidate programs, a strategic business merger and other transactions that maximize the value of the Company’s assets.