February 22, 2010
AVEO Initiates Enrollment in Phase 3 Clinical Trial Evaluating Tivozanib in Advanced Renal Cell Cancer
CAMBRIDGE, Mass., February 22, 2010 – AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced it has initiated enrollment in a global Phase 3 clinical trial for its oral, triple VEGF receptor inhibitor, tivozanib, in advanced renal cell cancer (RCC). This Phase 3 clinical trial, named TIVO-1, is evaluating the efficacy of tivozanib compared to sorafenib (Nexavar®), and is evaluating the progression-free survival of patients treated with tivozanib compared to the progression-free survival of patients treated with sorafenib, an anti-angiogenesis therapy for the treatment of RCC. This trial is underway at multiple sites around the world and is being led by Robert Motzer, M.D., attending physician at Memorial Sloan Kettering Cancer Center.
TIVO-1 is a randomized, controlled trial evaluating tivozanib compared to sorafenib. Sorafenib is approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for use in patients with advanced RCC. 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. Independent radiology review will be conducted for all CT scans and radiographs. 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. Patients will be randomized 1:1 to tivozanib or sorafenib. 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. Additional information on the trial design can be found online at http://www.clinicaltrials.gov/.
Prior to launching TIVO-1, AVEO successfully completed 272-patient Phase 2 clinical trial of tivozanib in patients with advanced RCC. Advanced RCC, which accounts for 80-85% of all malignant kidney tumors, is highly resistant to chemotherapy. Worldwide incidence of RCC is more than 200,000 cases annually, out of which approximately 57,000 new cases are diagnosed in North America.
Tivozanib (AV-951), AVEO’s lead product candidate, is a highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, exhibiting inhibitory activity against all three receptors. Inhibition of the VEGF pathway has demonstrated benefit for patients with a wide range of cancer types, including RCC, metastatic breast cancer, colorectal cancer, and non-small cell lung cancer. In addition, AVEO has evaluated tivozanib using its Human Response Platform (HRP™), a novel method of building preclinical models of human cancer, which are intended to more accurately represent cancer biology in patients.
In addition to the TIVO-1 trial, AVEO is currently conducting multiple phase 1b clinical trials of tivozanib in various combinations and dosing regimens in RCC and additional solid tumor indications, including breast cancer and colorectal cancer.
AVEO is a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics. Its product candidates are targeted against important mechanisms known or believed to be involved in cancer. For more information, please visit www.aveopharma.com.