December 2, 2010

New Clinical Data Evaluating AVEO’s Tivozanib in Combination with Paclitaxel to be Presented at 33rd Annual San Antonio Breast Cancer Symposium

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CAMBRIDGE, Mass., Dec 02, 2010 (BUSINESS WIRE) — AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that new clinical data from a Phase 1b trial evaluating the company’s lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with paclitaxel (Taxol(R)), a standard chemotherapy regimen, will be presented during the 33rd Annual San Antonio Breast Cancer Symposium (SABCS) being held December 8-12, 2010 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

“There are limited effective treatment options for women with metastatic breast cancer, and we believe the unique safety and efficacy profile demonstrated by tivozanib may make tivozanib well suited for use in combination with other anti-cancer agents to treat this disease,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “We look forward to sharing the new data from our ongoing Phase 1b clinical trial evaluating tivozanib in combination with paclitaxel with the breast cancer community.”

The details for the AVEO poster presentation at SABCS are as follows:

Date & Time: Friday, December 10, 2010 from 7:00-9:00 a.m. (CST)
Session: Poster Session 2
Location: Exhibit Halls A-B
Poster Title: Combination of Tivozanib, an Oral Inhibitor of VEGFR, with Weekly Paclitaxel for Metastatic Breast Cancer: Preliminary Results of an Ongoing Phase 1 Study
Abstract Number: P2-16-10
Presenter: E.L. Mayer

About Tivozanib

Tivozanib, an investigational new drug, is a highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, exhibiting picomolar inhibitory activity against all three receptors. Due to its potency and specificity, AVEO believes tivozanib may enable optimal inhibition of the VEGF pathway, while minimizing side effects associated with off-target activity. Such a profile may enable tivozanib to be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility. The EMA has granted AVEO orphan medicinal product designation for tivozanib for the treatment of advanced renal cell cancer (RCC).

AVEO recently completed patient enrollment ahead of schedule in TIVO-1, a global, randomized (1:1), controlled Phase 3 clinical trial evaluating tivozanib compared to sorafenib (Nexavar(R)) in patients with RCC. The company has initiated a series of clinical trials evaluating tivozanib in combination with other agents in multiple solid tumor settings, including an ongoing Phase 1b trial in combination with temsirolimus (Torisel(R)), an approved mTOR inhibitor, in patients with metastatic RCC; a Phase 1b trial in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers; a Phase 1b trial in combination with paclitaxel (Taxol(R)) in patients with metastatic breast cancer; and a Phase 1b trial in combination with oral capecitabine (Xeloda(R)) in patients with advanced breast and colorectal cancers. A Phase 1b trial evaluating tivozanib as monotherapy in patients with non-small cell lung cancer is also being conducted.

AVEO is also utilizing its Human Response Platform(TM) in its efforts to help identify rational drug combinations and patient populations most likely to be responsive to these combination therapies.

About AVEO

AVEO Pharmaceuticals (NASDAQ: AVEO) integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The company’s lead product candidate, tivozanib, is an oral, triple VEGF receptor inhibitor with a highly differentiated profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEO’s second most advanced product candidate, AV-299, is a potent, functional anti-HGF antibody that is currently in Phase 2 development. AVEO’s proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development and has provided a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR. For more information, please visit the company’s website at

Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about tivozanib’s safety and efficacy profile and its potential benefits in combination with other therapies; the planned presentation of new data from the ongoing Phase 1b clinical trial described in this press release; the unique advantages of our cancer biology platform in oncology drug development; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “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: our ability to successfully research, develop and obtain and maintain regulatory approvals for tivozanib and our other product candidates; the possibility that favorable data from the clinical trials described in this press release and our other preclinical and clinical trials of tivozanib and AV-299 may not be predictive of the results in future preclinical and clinical trials; delays in data availability, or negative results from our clinical trials; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our 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 our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

SOURCE: AVEO Pharmaceuticals, Inc.

Investor Contact:
AVEO Pharmaceuticals, Inc.
Monique Allaire, 617-299-5810
Media Contact:
Pure Communications
Caton Lovett, 910-232-7166