AVEO Initiates Phase 1b Combination Clinical Trial of Novel Triple VEGF Receptor Inhibitor AV-951 in Metastatic Renal Cell Carcinoma

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AVEO Initiates Phase 1b Combination Clinical Trial of Novel Triple VEGF Receptor Inhibitor AV-951 in Metastatic Renal Cell Carcinoma

CAMBRIDGE, MA, January 31, 2008 – AVEO Pharmaceuticals, Inc., a biotechnology company leveraging breakthrough discoveries in cancer biology to discover, develop and commercialize targeted oncology therapies, today announced that it has initiated a Phase 1b clinical trial for its lead product candidate, the novel triple VEGF receptor inhibitor AV-951, in combination with the FDA approved mTOR inhibitor temsirolimus (Torisel„§).  The open-label, sequential dose escalation study will be conducted at leading cancer institutions in the U.S. to evaluate the combination of AV-951 and temsirolimus in patients with metastatic renal cell carcinoma.  This is the first of several combination trials planned by AVEO to explore the potential use of AV-951 in combination with leading targeted therapies and chemotherapeutic regimens in several different cancers, including colorectal, breast and lung cancers.

“In addition to this Phase 1b combination trial, our ongoing 200-patient Phase 2 randomized discontinuation trial of AV-951 in patients with metastatic renal cell carcinoma will provide us with monotherapy proof of concept and establish a foundation for multiple potential cancer indications for AV-951,” stated Tuan Ha-Ngoc, president and chief executive officer of AVEO.  “Our single-agent and combination therapy clinical development strategy for AV-951, coupled with the added insights obtained through our proprietary biology platform, will enable AVEO to target patient populations who will most benefit from this novel product candidate and significantly enhance the commercial potential of AV-951 in a broad range of tumor types.  We look forward to obtaining interim data from our Phase 2 trial later this year.”

About the Phase 1b Combination Trial

The new Phase 1b combination therapy trial is designed to assess the safety, tolerability, and maximum tolerated dose of AV-951 when given in combination with temsirolimus in approximately 36 patients with metastatic renal cell carcinoma.  Patients will receive daily doses of AV-951 for three weeks, followed by one week off, and a weekly dose of temsirolimus. Treatment cycles will be repeated every four weeks, and disease evaluation will be performed after every two cycles.

In parallel with this Phase 1b combination trial, AVEO will study global and targeted gene expression patterns in all patients to evaluate biomarkers for response and patient selection. For more information about this and other AVEO clinical trials, please visit the NIH Clinical Trials web site at http://www.clinicaltrials.gov/.

“Due to the highly specific triple VEGF receptor inhibition of AV-951, we believe AV-951 offers a unique profile that will allow it to be easily combined with the current front-line regimens for cancer treatment, including targeted therapies and traditional chemotherapy regimens, potentially benefiting multiple tumor types,” said Pankaj Bhargava, M.D., vice president, clinical research at AVEO.  “This combination trial with temsirolimus and future combination trials are important in the context of our overall clinical development plan for AV-951.”

About AV-951

AV-951 is a novel, highly potent and specific inhibitor of VEGF receptors 1, 2 and 3. 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 specificity, AVEO believes AV-951 may be more readily combined with standard chemotherapy as well as other targeted therapies, potentially increasing the breadth of its clinical utility.  AVEO’s translational research effort, comprising its Human Response Platform, offers an opportunity to exploit AV-951’s unique characteristics and will provide further insight into potential clinical settings, combinability with other anti-cancer agents, tumor subtypes and responsive patient populations.

About AVEO

AVEO is a clinical-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), as well as collaborations with Eli Lilly, Merck, OSI Pharmaceuticals and Schering-Plough.  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 http://aveopharma.com/.