AVEO presents tivozanib Phase 2 study results at ESMO Congress

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) were presented at the 35^th European Society for Medical Oncology (ESMO) Congress in Milan, Italy. ESMO is the leading European oncology professional organization, committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care.

“We believe these data represent a potentially significant advance in the treatment of advanced kidney cancer”

"We believe these data represent a potentially significant advance in the treatment of advanced kidney cancer," said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. "With the recent completion of patient enrollment in TIVO-1, six months ahead of schedule, we look forward to Phase 3 data for tivozanib in advanced RCC, which we expect to obtain in mid-2011. We believe tivozanib's promising tolerability and efficacy profile suggests the potential for broad applicability and combinability with chemotherapies and other targeted agents. We are currently evaluating tivozanib as a single-agent and in combination with approved agents in clinical trials in RCC, gastrointestinal, metastatic breast, and lung cancers. We look forward to the opportunity of continuing to collaborate with the global medical oncology community to advance these efforts."

The Phase 2 clinical trial evaluated tivozanib in 272 patients with advanced RCC. Data showed that the median progression-free survival (PFS) achieved by patients with advanced clear cell RCC who had undergone a prior nephrectomy was 14.8 months - comparing favorably to historical data from trials testing other currently approved multikinase inhibitors in RCC. Median PFS among all 272 patients in the Phase 2 trial was 11.8 months. Hypertension was the most commonly reported treatment-related adverse effect, and was observed in 50% of treated patients. Development of hypertension was directly associated with improved clinical outcomes among patients overall and in the subset of patients with clear cell RCC who had undergone a prior nephrectomy. Off-target toxicities commonly associated with other targeted therapies, such as mucositis, fatigue and hand-foot syndrome, were notably low in the tivozanib group, which AVEO believes underscores a differentiated safety profile and potential for combinability with other therapeutic agents.

"I believe that tivozanib represents a potential therapeutic advance in the treatment of advanced kidney cancer," said Cora Sternberg, M.D., FACP, chief of medical oncology at San Camillo Forlanini Hospital, Rome, and TIVO-1 investigator. "The efficacy and tolerability demonstrated by these Phase 2 data further highlight the role that tivozanib may play in the treatment of patients with kidney cancer and other serious cancers, as a single agent or in combination with other therapies. I am pleased to be participating in the Phase 3 TIVO-1 trial, and look forward to learning more about this much-needed potential treatment option as those data become available."

These data were presented today by Dmitry A. Nosov, M.D., Ph.D., senior clinical researcher at the Blokhin Oncology Research Center, Moscow, Russian Federation, in an oral presentation titled, "Phase 2 Randomized Discontinuation Trial (RDT) of Tivozanib in Patients With Renal Cell Carcinoma (RCC): Results in Patients Randomized to Tivozanib vs. Placebo."