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12/13/2013 6:57:09 AM
AVEO Provides Update on Interim Analysis from Tivozanib Trial in Colorectal Cancer
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.
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.
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
Dan Budwick, 973-271-6085
SOURCE: AVEO Oncology
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