New Clinical Data on AVEO Oncology's Tivozanib and Ficlatuzumab to be Presented at the ESMO 2012 Congress

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

AVEO Oncology AVEO today announced that new clinical data on its lead product candidate tivozanib, partnered with Astellas Pharma Inc. (TSE: 4503), as well as its HGF inhibitory antibody ficlatuzumab will be presented at the European Society of Medical Oncology (ESMO) 2012 Congress in Vienna, Austria, September 28 – October 2, 2012.

“At this year's ESMO, investigators will present new data on both our lead product candidate tivozanib and our HGF inhibitory antibody ficlatuzumab,” said William Slichenmyer, M.D., Sc.M., chief medical officer, AVEO Oncology. “We believe the additional TIVO-1 analyses underscore the safety profile of tivozanib in RCC while the new ficlatuzumab data demonstrate its targeted inhibition of the HGF ligand. We look forward to sharing these data with the medical oncology community soon.”

The schedule for the tivozanib and ficlatuzumab data presentations at ESMO is as follows:

Date & Time: Saturday, September 29, 2012 at 1:00 p.m. (CEST)

Session: Poster presentation 1

Title: A randomized Phase (Ph) 2 study with exploratory biomarker analysis of ficlatuzumab (F) a humanized hepatocyte growth factor (HGF) inhibitory MAB in combination with gefitinib (G) versus G in Asian patients (PTS) with lung adenocarcinoma (LA)

Abstract Number: 1198P

Room: Hall XL

Presenter: Tony Mok, M.D.

Date & Time: Saturday, September 29, 2012 at 1:00 p.m. (CEST)

Session: Poster presentation 1

Title: Patient preference for tivozanib hydrochloride or sunitinib in the treatment of metastatic renal cell carcinoma (mRCC): TAURUS study

Abstract Number: 892TiP

Room: Hall XL

Presenter: Bernard Escudier, M.D.

Date & Time: Sunday, September 30, 2012 at 1:00 p.m. (CEST)

Session: Poster discussion

Title: Pharmacodynamic (PD) – Pharmacokinetic (PK) study of ficlatuzumab (F), a monoclonal antibody (MAB) directed to the hepatocyte growth factor (HGF), in patients (PTS) with advanced solid tumors who have liver metastases (METS)

Abstract Number: 443PD

Room: Hall H

Presenter: Maria Elena Elez, M.D.

Date & Time: Monday, October 1, 2012 at 1:15 p.m. (CEST)

Session: Poster discussion

Title: Detailed comparison of the safety of tivozanib versus sorafenib in patients with advanced/metastatic renal cell carcinoma (mRCC) from a Phase 3 trial

Abstract Number: 795PD

Room: Hall F2

Presenter: Tim Eisen, Ph.D., FRCP

Date & Time: Monday, October 1, 2012 at 1:15 p.m. (CEST)

Session: Poster discussion

Title: Tivozanib pharmacokinetic (PK)/pharmacodynamics (PD) analysis of blood pressure (BP) and soluble vascular endothelial growth factor receptor 2 (sVEGFR2) in patients with advanced renal cell carcinoma (RCC)

Abstract Number: 796PD

Room: Hall F2

Presenter: Dmitry Nosov, M.D., Ph.D.

About AVEO

AVEO Oncology AVEO is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients' lives. 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.

About the AVEO/Astellas Collaboration

In February 2011, AVEO and Astellas entered into a worldwide agreement outside of Asia to develop and commercialize tivozanib for the treatment of a broad range of cancers. Tivozanib, AVEO's lead investigational drug, is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off-target toxicities. Subject to regulatory approval, AVEO will lead commercialization of tivozanib in North America and Astellas will lead commercialization of tivozanib in the European Union (EU).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,” “will,” “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 therapeutic benefits of tivozanib and ficlatuzumab, and AVEO's plans to leverage its Human Response Platform™. 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: difficulties, delays and failures in AVEO's ability to successfully research, develop and obtain and maintain regulatory approvals for tivozanib, ficlatuzumab and AVEO's other product candidates; the possibility that tivozanib will not achieve the regulatory approvals required for its successful commercialization either in the U.S. or abroad; AVEO's inability to obtain and maintain adequate protection for intellectual property rights relating to AVEO's product candidates and technologies; unplanned operating expenses; AVEO's inability to raise substantial additional funds to achieve AVEO's goals; adverse general economic and industry conditions; and those risks discussed in “Risk Factors” and elsewhere in AVEO's most recent Quarterly Report on Form 10-Q and in its other filings with the Securities and Exchange Commission. 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 it 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.