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AVEO/Astellas Terminate Tivozanib Trial

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AVEO Pharmaceuticals, Inc. (AVEO - Free Report) and partner Astellas Pharma, Inc. announced their decision to discontinue a phase II study evaluating tivozanib in patients suffering from locally recurrent or metastatic triple negative breast cancer. The companies decided to end the phase II BATON (Biomarker Assessment of Tivozanib in ONcology) breast cancer (BC) study due to insufficient enrollment.

The randomized, double-blind, multi-center phase II BATON BC study was initiated in Dec 2012 to compare the efficacy of tivozanib plus Bristol-Myers Squibb’s (BMY - Free Report) Taxol (paclitaxel) with Taxol plus placebo in locally recurrent or metastatic triple negative breast cancer patients, who have not received or received one systemic therapy.

In its third quarter 2013 press release, AVEO had disclosed that the enrolment process for the phase II BATON BC study was slower than expected. Despite patient recruitment efforts, enrollment rates did not improve significantly.

This is the latest in tivozanib-related setbacks for AVEO. Last month, AVEO and Astellas had announced that data from a planned interim analysis of the phase II BATON– CRC (colorectal cancer) study on tivozanib revealed that the study was unlikely to meet the primary endpoint.

Prior to that, in June last year, the companies had received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for tivozanib for advanced renal cell carcinoma (RCC). The FDA had informed AVEO that the new drug application (NDA) was not approvable in its present form. Following the CRL, AVEO decided to discontinue tivozanib development for the advanced RCC indication.

Our Take

AVEO’s shares have plunged more than 75% over the last one year. Given the disappointing news related to tivozanib, we expect the shares to continue to fall further. We expect the company to increase its focus on other pipeline candidates including AV-203 (phase I – solid tumor).

AVEO carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Actelion Ltd. carrying a Zacks Rank #1 (Strong Buy).

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