AVEO Announces Patient Enrollment in Phase 2 Clinical Trial of Tivozanib in Combination with mFOLFOX6 in Patients with Advanced Colorectal Cancer

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today announced the initiation of patient enrollment in an open-label, multicenter, randomized Phase 2 clinical trial, called BATON-CRC, evaluating tivozanib in combination with modified FOLFOX6 (mFOLFOX6) compared to bevacizumab in combination with mFOLFOX6 as first-line therapy in patients with advanced metastatic colorectal cancer (CRC). BATON-CRC is the second trial to be initiated as part of the BATON (Biomarker Assessment of Tivozanib in ONcology) program, a series of clinical trials planned to assess tivozanib biomarkers in solid tumors. BATON-RCC, a Phase 2 exploratory biomarker study in patients with advanced renal cell carcinoma, was initiated by AVEO in early 2011.

“There have been a number of advances in the treatment of metastatic colorectal cancer, particularly over the past decade, which have extended patients’ survival; however, there remains an urgent need for new agents to further improve outcomes for patients,” said Al Benson, M.D., F.A.C.P., professor of medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine, and BATON-CRC primary investigator. “It is critical that we develop strategies that will enhance our understanding of patient populations that will best respond to specific therapeutic regimens, and I believe that BATON-CRC is a step forward on this front. I am excited to be involved in this trial and to learn more about how this treatment regimen with tivozanib may benefit patients living with colorectal cancer.”

BATON-CRC, which is being led by AVEO’s collaborator Astellas Pharma Inc. (Tokyo:4503, “Astellas”), will enroll approximately 252 patients with no prior VEGF-targeted therapy at approximately 80 centers in the U.S., Canada, Australia and Europe. Patients will be randomized to one of the two treatments arms in a 2:1 ratio (168 patients in the tivozanib arm and 84 patients in the bevacizumab arm). One component of BATON-CRC is the assessment of biomarker relationships that may be predictive of response, including lactate dehydrogenase (LDH). LDH is a protein that normally appears throughout the body in small amounts and can be elevated in patients with certain cancers, including colorectal cancer. Measuring LDH levels can be helpful in monitoring cancer treatment and determining patients’ response to therapy. For additional information, please visit clinicaltrials.gov.

“BATON-CRC is further example of AVEO’s commitment to patient care and advancing the science behind biomarkers,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “The identification and development of relevant biomarkers through our Human Response Platform is a core component of our oncology drug development efforts. We plan to use biomarker data from BATON-CRC and BATON-RCC to inform our clinical development strategy in an effort to bring tivozanib to the patients who will benefit most.”

A Phase 1b clinical trial evaluating tivozanib in combination with mFOLFOX6 in patients with advanced gastrointestinal (GI) cancers, including colorectal cancer, was completed by AVEO last year. Results showed partial responses in more than a third (35 percent) of patients evaluated (n=17) and disease control in 82 percent of patients; and, the combination was considered tolerable at the full tivozanib dose (1.5 mg/day) and standard mFOLFOX6 dose.

About Colorectal Cancer

The American Cancer Society (ACS) estimates that more than 140,000 men and women in the U.S. will be diagnosed with colorectal cancer (CRC) and nearly 50,000 will die of the disease in the U.S. in 2011. CRC is the third most commonly diagnosed cancer in both men and women and the third leading cause of cancer death in the U.S. [ACS, 2011]. In Europe, it is estimated that almost 180,000 men and women are diagnosed with CRC and that nearly 80,000 die from the disease each year [Ferlay, Parkin and Steliarova-Foucher, 2010].

About Tivozanib

Tivozanib is a potent, selective and continuous inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off-target toxicities. Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor that is in a Phase 3 clinical study in advanced renal cell carcinoma, and is also being evaluated in other tumors.

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. 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).

About AVEO

AVEO Pharmaceuticals (NASDAQ: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients’ lives. AVEO’s proprietary Human Response Platform™ 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.aveopharma.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements in this press release about AVEO’s future expectations, plans and prospects, including statements about: the potential efficacy and safety of tivozanib; whether the BATON-CRC regimen may benefit patients with colorectal cancer; leveraging AVEO’s Human Response Platform to maximize the clinical potential of tivozanib; whether BATON-CRC may inform the future design of clinical trials; making tivozanib available to patients who can benefit most; the potential of AVEO’s cancer biology platform to offer a unique advantage in oncology drug development, including enriching outcomes and minimizing development risks of tivozanib; and other statements containing the words "believes," "anticipates," "plans," "expects," “potential,” "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: AVEO’s ability to successfully research, develop and obtain and maintain regulatory approvals for tivozanib and its other product candidates; the possibility that favorable historical preclinical and clinical trial results may not be predictive of the results in future preclinical and clinical trials; 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 its goals, including with respect to the further development of tivozanib; competition; general economic and industry conditions; and other factors discussed in the "Risk Factors" section of AVEO’s most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that AVEO periodically makes with the SEC. In addition, the forward-looking statements included 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, AVEO specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing AVEO’s views as of any date subsequent to the date of this press release.