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AVEO Provides Update on Interim Analysis from Tivozanib Trial in Colorectal Cancer



  AVEO Provides Update on Interim Analysis from Tivozanib Trial in Colorectal
  Cancer

Business Wire

CAMBRIDGE, Mass. -- December 13, 2013

AVEO Oncology (NASDAQ: AVEO) today announced that data from a planned interim
analysis of the Phase 2 BATON (Biomarker Assessment of Tivozanib in ONcology)
study in patients with colorectal cancer (CRC) indicate that the study is
unlikely to meet the primary endpoint in the intent-to-treat patient
population.

BATON-CRC, led by Astellas, is an open-label, randomized Phase 2 study with a
primary endpoint evaluating the superiority of tivozanib in combination with
modified FOLFOX6, a standard chemotherapy, compared to bevacizumab in
combination with modified FOLFOX6 as first-line treatment in patients with
advanced metastatic CRC. A component of the BATON-CRC study is the assessment
of biomarker relationships that may be predictive of response in select,
pre-defined patient subpopulations.

Data from the planned interim analysis, including biomarker data, are being
analyzed, and AVEO and Astellas are in discussions regarding next steps.

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a cancer therapeutics company committed to
discovering and developing targeted therapies designed to provide substantial
impact in patients’ lives by addressing unmet medical needs. AVEO’s
proprietary Human Response Platform^TM provides the company unique insights
into cancer biology and is being leveraged in the discovery and clinical
development of its cancer therapeutics. For more information, please visit the
company’s website at www.aveooncology.com.

Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the
meaning of The Private Securities Litigation Reform Act of 1995 that involve
substantial risks and uncertainties. All statements, other than statements of
historical facts, contained in this press release are forward-looking
statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,”
“may,” “plan,” “target,” “potential,” “could,” “should,” “seek,” or the
negative of these terms or other similar expressions, are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. These forward-looking statements include,
among others, statements about AVEO’s plans to leverage its Human Response
Platform; and AVEO and Astellas’ plans to analyze the data from the interim
analysis and consider next steps. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in the
forward-looking statements that AVEO makes due to a number of important
factors, including risks relating to: AVEO’s ability to execute on its
business plan and manage the impact of unplanned operating expenses; AVEO’s
ability to successfully enroll and complete clinical trials and preclinical
studies of its product candidates; AVEO’s ability to demonstrate to the
satisfaction of the FDA, or equivalent foreign regulatory agencies, the
safety, efficacy and clinically meaningful benefit of its product candidates;
AVEO’s ability to achieve and maintain compliance with all regulatory
requirements applicable to its product candidates; AVEO’s ability to obtain
and maintain adequate protection for intellectual property rights relating to
its product candidates and technologies; developments and expenses related to
AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise
the substantial additional funds required to achieve its goals; adverse
general economic and industry conditions; competitive factors; AVEO’s ability
to maintain its strategic partnerships and relationships, including its
collaboration with Astellas; and those risks discussed in the section titled
“Risk Factors” included in AVEO’s most recent Quarterly Report on Form 10-Q
and in its other filings with the SEC. The forward-looking statements in this
press release represent AVEO’s views as of the date of this press release.
AVEO anticipates that subsequent events and developments will cause its views
to change. However, while AVEO may elect to update these forward-looking
statements at some point in the future, it specifically disclaims any
obligation to do so. You should, therefore, not rely on these forward-looking
statements as representing AVEO’s views as of any date subsequent to the date
of this press release.

Contact:

AVEO Investor Relations
617-299-5810
or
Media:
Pure Communications
Dan Budwick, 973-271-6085
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