AVEO Initiates Phase 1b Combination Trial Of AV-951 With FOLFOX6 In Patients With Advanced Colorectal And Other Gastrointestinal Cancers

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Cancer / Oncology;  Colorectal Cancer;  Clinical Trials / Drug Trials
Article Date: 08 Sep 2008 - 0:00 PDT

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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 another Phase 1b clinical study for its lead product candidate, the novel triple VEGF receptor inhibitor AV-951. This open-label, sequential dose escalation study will be conducted at leading cancer institutions in Europe and will evaluate AV-951 in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers. VEGF-targeted therapy is currently the standard of care in combination with chemotherapy for patients with colorectal cancer.

"With the recently completed enrollment for our Phase 2 trial and the launch of our second combination therapy trial, I am very pleased with the progress we are making on the clinical development program for AV-951," said Tuan Ha-Ngoc, president and chief executive officer of AVEO. "Due to the compelling activity and safety we have observed in our early data, we believe AV-951 offers a unique profile that will allow it to be used in combination with the current front-line regimens for cancer treatment, potentially benefitting the thousands of patients worldwide battling advanced colorectal cancer."

This Phase 1b combination therapy trial is designed to determine the safety, tolerability, and maximum tolerated dose of AV-951 when given in combination with FOLFOX6 in approximately 30 patients with advanced colorectal cancer and other gastrointestinal cancers.

Patients will receive once daily doses of AV-951 for three weeks followed by a one-week break, and FOLFOX6 (5FU, leucovorin and oxaliplatin) chemotherapy at standard doses once every two weeks. One cycle will be defined as 4 weeks of therapy, and patients will undergo tumor assessments after every two cycles (i.e. every 8 weeks). In the absence of disease progression or a serious adverse event, patients may continue to receive therapy with this regimen. This study also includes an expansion cohort of an additional 12 patients with previously untreated metastatic colorectal cancer to evaluate preliminary clinical activity of this regimen in first-line treatment of colorectal cancer. For more information about trials of AV-951, please visit the NIH clinical trials Web site at http://www.clinicaltrials.gov.

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 (HRP™), 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.

In addition to the initiation of the Phase1b combination trial with the FOLFOX6 chemotherapy regimen, AVEO recently initiated a separate Phase 1b trial in combination with temsirolimus, an approved mTOR inhibitor, in patients with metastatic renal cell carcinoma (mRCC). AVEO also recently completed enrollment in its large, Phase 2 randomized discontinuation trial of AV-951 as a single-agent therapy in VEGF-naïve patients with mRCC.

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, FGFR), 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.

AVEO Pharmaceuticals, Inc.

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