AVEO and Astellas Discontinue Phase 2 Trial of Tivozanib in Breast Cancer

  AVEO and Astellas Discontinue Phase 2 Trial of Tivozanib in Breast Cancer

Business Wire

CAMBRIDGE, Mass. -- January 30, 2014

AVEO Oncology (NASDAQ: AVEO) today announced that AVEO and Astellas Pharma
Inc. have jointly decided to discontinue the BATON (BiomarkerAssessment
ofTivozanib inONcology) breast cancer clinical trial, a Phase 2 study in
patients with locally recurrent or metastatic triple negative breast cancer
(TNBC), due to insufficient enrollment. AVEO previously announced that
enrollment in this study had been slower than anticipated, and enrollment
rates did not improve substantially following additional patient recruitment
efforts.

“While we believe in the potential benefits of tivozanib for patients with
triple negative breast cancer, we have decided to discontinue the trial
because of low patient accrual,” stated William Slichenmyer, M.D., Sc.M.,
chief medical officer at AVEO. “We want to thank the study investigators and
their patients who participated in the trial for their support.”

The BATON-BC study initiated patient enrollment in December 2012 in a
randomized, double-blind, multicenter Phase 2 clinical trial, evaluating the
efficacy of tivozanib in combination with paclitaxel compared to placebo in
combination with paclitaxel in patients with locally recurrent or metastatic
triple negative breast cancer who have received no more than one systemic
therapy for advanced or metastatic breast cancer. All committed expenses
related to the BATON-BC study are shared equally between AVEO and Astellas.

Separately, as announced in December 2013, data from a planned interim
analysis of the Phase 2 study of tivozanib in patients with colorectal cancer
indicate that the study is unlikely to meet the primary endpoint in the
intent-to-treat patient population. Interim data are being evaluated, 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 the potential benefits of tivozanib for
patients with triple negative breast cancer; and AVEO and Astellas’ plans to
evaluate the data from the interim analysis of the phase 2 clinical data for
colorectal cancer and discussions regarding 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 Oncology
Investor Relations
617-299-5810
or
Pure Communications
Dan Budwick, 973-271-6085
 
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