AVEO Pharmaceuticals Announces Oral Presentation of Data from AV-951 Phase 2 Clinical Trial at the 2009 Genitourinary Symposium

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AVEO Pharmaceuticals Announces Oral Presentation of Data from AV-951 Phase 2 Clinical Trial at the 2009 Genitourinary Symposium

CAMBRIDGE, Mass., February 11, 2009 – AVEO Pharmaceuticals, Inc. today announced that interim safety and efficacy results from the Phase 2 clinical trial of its lead product AV-951 – a novel, highly potent and selective triple VEGF receptor inhibitor – will be presented during an oral abstract session at the 2009 Genitourinary (GU) Cancers Symposium. This multidisciplinary symposium, co-sponsored by the American Society of Clinical Oncology, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology, is being held February 26-28, 2009 at the Orlando World Center Marriott Resort & Convention Center in Orlando, FL.

Interim safety and efficacy data from the study will be presented at the GU Cancers Symposium by Pankaj Bhargava, M.D., vice president, clinical research for AVEO, during the renal cell cancer oral abstract session taking place on Saturday, February 28, from 1:30 p.m. - 3:00 p.m. The company plans to present complete results from the trial at an upcoming medical meeting later this year.

Data from this presentation, titled “Activity and safety of AV-951, a potent and selective VEGFR1, 2 and 3 kinase inhibitor, in patients with renal cell carcinoma (RCC): Interim results of a Phase 2 randomized discontinuation trial,” will also be on view at the GU Cancers Symposium as part of the renal cell cancer general poster session E and poster walk on Saturday, February 28, from 12:30 p.m. - 1:30 p.m.“We are very pleased to be presenting interim Phase 2 trial results for AV-951 at the upcoming GU Cancers Symposium,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “This Phase 2 trial of AV-951 for the treatment of patients with metastatic renal cell carcinoma (mRCC) exceeded enrollment goals with more than 270 patients participating. We believe the high level of investigator and patient interest suggests a significant market opportunity for a more potent and selective VEGF receptor inhibitor such as AV-951 and we look forward to sharing an early look into the Phase 2 results with the oncology community.”

About the Study

This Phase 2 placebo-controlled, randomized discontinuation trial assessed the safety and efficacy of once-daily, oral AV-951 in metastatic renal cell carcinoma patients naïve to VEGF targeted therapy at more than 30 sites in Europe and India under a U.S. investigational new drug (IND) application. In this trial, all patients received 16 weeks of AV-951, after which time patients were evaluated for response. Those patients who achieved >25% tumor regression remained on therapy, while those patients who experienced <25% change from baseline were randomized to receive 12 weeks of AV-951 or placebo in a double-blind fashion. The primary endpoints of this trial are objective response rate after 16 weeks of treatment, percentage of patients who are progression free at 12 weeks following randomization (i.e. 28 weeks after study entry), and safety.  For more information, please visit the NIH Clinical Trials web site at http://www.clinicaltrials.gov.

About AV-951

AV-951 is a novel, highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, exhibiting picomolar inhibitory activity against all three receptors. Angiogenesis inhibition has demonstrated benefit for patients with a wide range of cancer types, including renal cell carcinoma, metastatic breast cancer, colorectal cancer, and non-small cell lung cancer. Due to its potency and specificity, AVEO believes AV-951 may enable optimal inhibition of the VEGF pathway, while avoiding many side effects often associated with off-target binding. Such a profile may enable AV-951 to be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility. In addition, AVEO has evaluated AV-951 using its Human Response Platform (HRP™), a unique set of engineered tumor models that provide further insight into potential clinical settings, combinability with other anti-cancer agents, tumor subtypes and responsive patient populations.

In addition to this Phase 2 trial, AVEO is conducting an ongoing Phase 1b trial of AV-951 in combination with temsirolimus, an approved mTOR inhibitor, in patients with mRCC, and a Phase 1b combination trial of AV-951 with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers. 

About AVEO

AVEO is a late-stage biopharmaceutical company focused on the discovery and development of novel, targeted cancer therapeutics. AVEO’s proprietary, integrated cancer biology platform enables the company to pursue highly efficient drug development strategies in oncology that increase the probability of clinical success and provides a discovery engine for high-value targets. This approach has resulted in a balanced pipeline of novel cancer therapies focused on well-validated targets (VEGFR, EGFR) and promising novel targets (HGF, FGFR), as well as collaborations with Eli Lilly, Merck, OSI Pharmaceuticals and Schering-Plough. The company’s lead product, AV-951, a potential best-in-class triple VEGF receptor inhibitor, is in a Phase 2 clinical trial in patients with metastatic renal cell cancer and is expected to enter Phase 3 development in 2009. Through a combination of internal drug discovery and selective in-licensing of targeted therapeutics, AVEO is building a diversified product pipeline and moving toward its vision of becoming a fully integrated biopharmaceutical company. For more information, please visit the company's website at www.aveopharma.com.