AVEO commences enrollment in Phase 1b combination trial of tivozanib with oral capecitabine in advanced tumors

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that it has initiated patient enrollment in an open-label, multi-center Phase 1b clinical trial evaluating tivozanib in combination with oral capecitabine (Xeloda®) in patients with certain advanced solid tumors. This is one of several combination trials ongoing to explore the potential use of tivozanib in combination with leading targeted therapies and chemotherapeutic regimens in multiple cancers including kidney, colorectal and breast cancers.

“We believe this Phase 1b trial evaluating tivozanib in combination with oral capecitabine in patients with colorectal and breast cancers may provide further evidence of tivozanib's utility as a valuable addition to widely used cancer treatment regimens, in addition to being an effective and tolerable monotherapy option”

"Finding a potent and selective oral VEGF inhibitor that safely and effectively combines with other anti-cancer agents would represent a step forward for treating advanced cancers in a variety of tumor types," stated Skip Burris, M.D., chief medical officer and director of drug development at the Sarah Cannon Research Institute. "Combining investigational tivozanib, which targets VEGF receptors 1, 2 and 3 and has demonstrated the potential for favorable safety and tolerability, with an oral chemotherapeutic drug like capecitabine, may offer a therapeutic advance and a convenient dosing regimen for patients with breast and colorectal cancers."

This trial is designed to assess the safety, tolerability and maximum tolerated dose (MTD) of tivozanib when given in combination with oral capecitabine, a chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers, in approximately 24 patients with advanced solid tumors at three U.S. sites. In the expansion cohort of the trial, up to 12 patients with locally advanced or metastatic breast or colorectal cancer are expected to be enrolled to further evaluate safety and activity of this combination in these tumor types.

"We believe this Phase 1b trial evaluating tivozanib in combination with oral capecitabine in patients with colorectal and breast cancers may provide further evidence of tivozanib's utility as a valuable addition to widely used cancer treatment regimens, in addition to being an effective and tolerable monotherapy option," said Tuan Ha-Ngoc, president and chief executive officer of AVEO. "The clinical data we are generating with tivozanib in our Phase 1b combination studies are informing our development strategy as we look toward potential registration paths in multiple tumor types in the future. We look forward to presenting additional combination data at upcoming medical congresses this year."

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