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AVEO And Astellas Announce New Data Presented At ESMO 2012 Congress Demonstrating The Safety And Tolerability Profile Of Tivozanib In Patients With Advanced Kidney Cancer

Title: Patient Preference for Tivozanib Hydrochloride or Sunitinib in the Treatment of Metastatic Renal Cell Carcinoma (mRCC): TAURUS studyDate/Poster/Location: Sep. 29, 1:00-2:00pm CET / 7:00-8:00am ET; Poster #892TiP; Hall XL

A review of the clinical study design of TAURUS, a randomized (1:1), double-blind, crossover controlled, multi-center Phase 2 study comparing tivozanib versus sunitinib in approximately 160 patients with advanced RCC who have received no prior systemic therapy was presented at the meeting. The primary objective of the study is to compare patient preference for tivozanib or sunitinib.

The first patient has been enrolled in TAURUS, and the study will continue to enroll patients at sites throughout the United States and Western Europe.

About Kidney Cancer

Advanced RCC, or kidney cancer, is the ninth most commonly diagnosed cancer in men and women in the U.S. 8 Worldwide it is estimated that more than 250,000 people are diagnosed and more than 100,000 people die from the disease each year. 9 RCC accounts for more than 90 percent of all kidney cancers. 10 Currently available therapies provide less than one year of median PFS in treatment naïve patients and are associated with significant toxicities. 11 These toxicities not only lead to high rates of dose reductions and interruptions (potentially compromising efficacy), but also can impact a patient’s quality of daily living. 12

About Tivozanib

Tivozanib is the first investigational compound to demonstrate a combination of statistically significant PFS and tolerability in a pivotal study for advanced RCC versus an approved targeted agent, sorafenib. Tivozanib is a potent, selective and 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, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor (TKI) for which positive results from a Phase 3 clinical study in advanced RCC have been reported, and is being evaluated in other tumors.

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