AVEO achieves enrollment target for tivozanib global Phase 3 clinical trial in advanced renal cell carcinoma

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that it has achieved its enrollment target for TIVO-1, its global Phase 3 clinical trial for its oral, triple VEGF receptor inhibitor, tivozanib, in patients with advanced renal cell carcinoma (RCC). In February of this year, AVEO initiated enrollment in TIVO-1, and has successfully reached the target enrollment of 500 patients.

"The enrollment in this trial underscores the need for improved treatment options for this difficult-to-treat cancer," stated Robert Motzer, M.D., attending physician at Memorial Sloan-Kettering Cancer Center and global lead TIVO-1 study investigator. "The results from this trial have the potential to provide the medical community with an understanding of tivozanib's efficacy and tolerability in patients with advanced renal cell carcinoma."

TIVO-1 is a global, randomized (1:1), controlled trial evaluating tivozanib compared to sorafenib. The primary endpoint of the trial is to compare the progression-free survival (PFS) of tivozanib vs. sorafenib. Secondary endpoints include overall survival, objective response rate, duration of response and quality of life. Patients with RCC of clear cell histology that have had a prior nephrectomy and that have not received prior VEGF-targeted therapy are eligible for this trial. Prior to entering the trial, independent, central review of the CT scans was required for all patients to ensure patients met the eligibility criteria regarding measureable disease. During treatment, scans are being obtained every eight weeks, and, again, are centrally reviewed by blinded independent reviewers. Patients who demonstrate disease progression during treatment with sorafenib will have the opportunity to be treated with tivozanib by participating in a separate long-term treatment protocol.

"We are very pleased to see TIVO-1 reach our enrollment target six months ahead of schedule, and I want to thank our investigators for their enthusiastic support for and tremendous commitment to the development of tivozanib," said Tuan Ha-Ngoc, president and chief executive officer of AVEO. "We believe this successful enrollment is a tribute to the differentiated safety and efficacy data of tivozanib observed in the Phase 2 trial. Based on achieving this milestone this early, we expect data from TIVO-1 to be available in mid-2011."

Prior to launching TIVO-1, AVEO successfully completed a 272-patient Phase 2 clinical trial of tivozanib in patients with advanced RCC. Data from the Phase 2 trial showed that the median PFS achieved by patients with advanced clear cell RCC who had undergone a prior nephrectomy, the patient population also being studied in TIVO-1, was 14.8 months - comparing favorably to historical data from trials testing other currently approved multikinase inhibitors in RCC. Hypertension, which has been proposed as a biomarker of clinical effect among agents targeting the VEGF receptor tyrosine kinases in RCC, was the most commonly reported treatment-related adverse effect, and was observed in 50% of treated patients. In the Phase 2 study, 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 favorable tolerability profile and potential for combinability with other therapeutic agents.