AVEO Initiates Phase 1b/2a Combination Trial of Novel, Triple VEGF Receptor Inhibitor
CAMBRIDGE, Mass., February 19, 2009 – AVEO Pharmaceuticals, Inc., a biotechnology company leveraging breakthrough discoveries in cancer biology to discover, develop and commercialize targeted oncology therapies, today announced the initiation of a Phase 1b/2a clinical trial in breast cancer, expanding on the broad development program for its lead product candidate, the novel, oral triple VEGF receptor inhibitor AV-951. This is the third cancer indication being explored by AVEO for the potential combined use of AV-951 with leading targeted agents and/or chemotherapeutic regimens. The Company launched the Phase 1b portion of this new open-label study at leading cancer institutions in the U.S. and E.U., to evaluate the combined daily dose of escalating, sequential doses of oral AV-951 with standard weekly intravenous administration of paclitaxel (Taxol™) in patients with advanced breast cancer.
Safety, tolerability and maximum tolerated dose (MTD) will be observed as the primary outcomes of the Phase 1b portion of this Phase 1b/2a trial in approximately 20 patients with progressive disease. Once MTD is determined, the subsequent Phase 2a portion of the trial will evaluate clinical activity of a combined AV-951/paclitaxel treatment regimen in 25-50 patients with metastatic breast cancer and no prior exposure to chemotherapy or VEGF-targeted therapies.
“Despite encouraging advances in the treatment of breast cancer, including a recent decline in incidence rates, breast cancer remains the most frequently diagnosed cancer in women, and we lose far too many lives to the disease. From a clinician’s viewpoint, new approaches are needed. There is great focus today on targeted therapies, and it is assumed that many of these new targeted treatments will be combined with our standard chemotherapeutic and hormonal approaches. Ideally, we need targeted therapies that are active, specific, and have very few side effects,” stated Eric P. Winer, M.D., director of the Breast Oncology Center and chief of the Division of Women’s Cancers at the Dana-Farber Cancer Institute. “AV-951 is a highly specific VEGF receptor inhibitor that has a very acceptable safety profile and is ready to be combined with standard treatments, such as chemotherapy. Our group is presently working with AVEO to explore the safety and efficacy of the combination of AV-951 and paclitaxel in the treatment of women with metastatic breast cancer.”
In parallel with this Phase 1b/2a 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.
“This Phase 1b/2a clinical trial of oral AV-951 in combination with paclitaxel is a strong addition to our robust development program for AV-951, led by our Phase 2 monotherapy study in renal cell carcinoma, as well as our ongoing combination therapy trials in renal and colorectal cancer,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “We continue to establish a solid foundation for AV-951 in the treatment of multiple cancer indications, and, coupled with the additional insights provided by our proprietary biology platform, we are coming closer to achieving our goal of delivering best-in-class, targeted cancer therapies to doctors and their patients most likely to benefit.”
About AV-951AV-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 the Phase 2 study in RCC, AVEO has initiated ongoing Phase 1b clinical trials of AV-951: in combination with temsirolimus, an approved mTOR inhibitor, in patients with mRCC; in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers; and in combination with paclitaxel in patients with metastatic breast cancer.
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 more than 270 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.