AVEO Pharmaceuticals Initiates Phase 2 Clinical Trial Evaluating SCH 900105 (AV-299) in Non-Small Cell Lung Cancer

06/05/10
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Results of Phase 1 Trial Presented at ASCO Annual Meeting

CAMBRIDGE, Mass., Jun 05, 2010--AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that it has initiated a Phase 2 clinical trial evaluating SCH 900105 (also referred to as AV-299) for the treatment of non-small cell lung cancer. The initiation of this trial triggers an $8.5 million milestone payment by Merck to AVEO resulting from a 2007 agreement between AVEO and Schering-Plough (now Merck). In addition, AVEO announced the presentation of results of a Phase 1 safety and tolerability trial of SCH 900105, an investigational antibody targeting hepatocyte growth factor/scatter factor (HGF/SF), at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago.

"Efforts to advance development of SCH 900105, our lead antibody candidate, have been guided by our unique and proprietary Human Response Platform(TM), and we believe these Phase 1 data further demonstrate the applicability of AVEO's informed approach to drug discovery and development," said Tuan Ha-Ngoc, president and chief executive officer of AVEO Pharmaceuticals. "We are enthusiastic about advancing clinical research to Phase 2."

SCH 900105 is a humanized anti-HGF IgG1 monoclonal antibody which has shown potent anti-tumor activity in vitro and in xenograft models. The HGF/c-Met pathway is involved in cell proliferation, angiogenesis, survival, migration and invasion. Preclinical data presented at the American Association of Cancer Research (AACR) meeting in 2009 demonstrated that SCH 900105 is efficacious in glioblastoma multiforme (GBM), non-small cell lung cancer (NSCLC) and pancreatic cancer models. In the U87 GBM model, SCH 900105 administration resulted in complete tumor regressions even after withdrawal of treatment. In addition, several preclinical combination studies performed with SCH 900105 and other targeted therapeutics, chemotherapies and anti-angiogenic agents demonstrated additive efficacy in vivo. Based on the preclinical data and the Phase 1 results, AVEO has initiated a Phase 2 trial of SCH 900105 in combination with gefitinib in patients with non-small cell lung cancer.

Tony Mok, M.D., professor, department of clinical oncology, Prince of Wales Hospital, Hong Kong, and senior investigator of the Phase 2 trial commented, "The preclinical results combined with the results of the Phase 1 trial provide an encouraging platform for further assessment of this candidate antibody. I look forward to the potential insights we expect to obtain from the Phase 2 trial of SCH 900105 in combination with gefitinib in patients with non-small cell lung cancer."

SCH 900105 (AV-299) Phase 1 Study Details

The Phase 1 study was an open-label, dose-escalation study evaluating SCH 900105 as a single agent in 37 patients with a variety of solid tumors, including sarcoma, ovarian, mesothelioma and GBM. Primary study objectives were to determine the safety, tolerability, dose-limiting toxicities (DLTs) and recommended Phase 2 dose(s) of SCH 900105 when administered via IV in subjects with relapsed or refractory solid tumors, and to determine the safety, tolerability, and DLTs of SCH 900105 in combination with erlotinib in subjects with relapse or refractory solid tumors. The study showed good tolerability with no dose limiting toxicities up to the highest dose tested, 20mg/kg. These data are being presented today at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), abstract number 2525.

Additionally, AVEO is conducting two separate, ongoing extensions of the Phase 1 trial evaluating SCH 900105 in combination with erlotinib in patients with a variety of solid tumors and SCH 900105 as monotherapy in patients with multiple myeloma.

SCH 900105 (AV-299) Phase 2 Trial Design

AVEO has initiated enrollment in a multi-center, randomized, open-label Phase 2 trial evaluating SCH 900105 in combination with gefitinib in patients with non-small cell lung cancer. Patients will be randomized 1:1 to receive SCH 900105 in combination with gefitinib or gefitinib monotherapy. Patients who demonstrate disease progression during treatment with gefitinib alone will have the opportunity to be treated with SCH 900105 in combination with gefitinib provided that safety is maintained and the patient continues to meet trial eligibility criteria. For more information, please visit www.clinicaltrials.gov.
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