AVEO Pharmaceuticals' Tivozanib Clinical Data Featured at 2011 ASCO Gastrointestinal Cancers Symposium

01/21/11
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CAMBRIDGE, Mass., Jan 21, 2011 -- AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today announced that previously reported positive data from its Phase 1b clinical trial evaluating tivozanib, its lead product candidate designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, in combination with FOLFOX6, a standard chemotherapy regimen, in patients with advanced gastrointestinal (GI) cancers will be presented tomorrow at the American Society of Clinical Oncology (ASCO) 2011 Gastrointestinal Cancers Symposium. Results from this study, which were previously reported at the EORTC-NCI-AACR Symposium in Berlin in November 2010, showed the combination was tolerable and safe at the full recommended tivozanib dose (1.5 mg/day) and schedule and standard FOLFOX6 dose; and, partial responses in more than a third (35 percent) of patients evaluated (n=17) and disease control in 82 percent of patients.

William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO, said, "Based on the results of the combination trials conducted to-date, we believe that tivozanib's unique characteristics allow it to be combined with other anti-cancer agents at full dose and schedule. Throughout 2010, we presented data from Phase 1b studies in metastatic breast cancer, colorectal cancer and renal cell carcinoma (RCC) where tivozanib demonstrated combinability with Taxol(R), FOLFOX6 and Torisel(R), respectively. When reviewed together with the monotherapy data from our Phase 2 trial in RCC, we believe that there is significant potential for tivozanib across multiple tumor types."

The details for the AVEO poster presentation are as follows:

Date & Time: Saturday, January 22, 2011 from 6:45-7:45 a.m. (PST) Session: General Poster Session C
Abstract Number: 549
Poster Title: A phase 1b, open-label, dose-escalation study of tivozanib and FOLFOX6 in patients with advanced gastrointestinal (GI) tumors
Poster Number: A194
Presenter: Jaroslaw Jac, M.D. Following the presentation, the poster will be available in the publications section of the company's website at investor.aveopharma.com.

About Tivozanib
Tivozanib, an investigational new drug, is designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors. Each of the three receptors of the VEGF pathway play an important role in angiogenesis (the formation of new blood vessels), which is critical in cancer cell growth. Tivozanib's high level of potency across VEGF receptors 1, 2 and 3 is designed to provide the most complete blockade of the VEGF pathway. Tivozanib's high level of selectivity for VEGF receptors 1, 2 and 3 is designed to minimize off-target toxicities, and its oral, one capsule, once-daily administration may enhance convenience for patients. Tivozanib has also demonstrated the ability to be combined with both targeted therapies and chemotherapies at the full dose and schedule1-3. AVEO is leveraging its Human Response Platform(TM) in order to enrich outcomes and minimize development risks for tivozanib.

In a large, multi-center, randomized Phase 2 clinical trial, the subset of patients with clear cell renal cell carcinoma (RCC) who had a prior nephrectomy receiving tivozanib therapy achieved 14.8 months progression free survival (PFS), the longest PFS reported for a single-agent therapy in this population4. The safety profile of tivozanib observed in the Phase 2 trial was notable for the minimal off-target toxicities often associated with VEGF, multi-targeted therapies. There was a low incidence of diarrhea, fatigue, stomatitis and hand-foot syndrome. Hypertension and dysphonia (hoarseness of voice), which are mechanism-related side effects associated with angiogenesis inhibitors, were the most commonly reported drug-related side effects, and both were manageable and reversible4. AVEO has completed patient enrollment in TIVO-1, a global, randomized, controlled Phase 3 clinical trial evaluating the efficacy of tivozanib compared to sorafenib (Nexavar(R)) in this same patient population. AVEO expects to announce top-line data from TIVO-1 in mid-2011.

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