AVEO's initiation of SCH 900105 Phase 2 trial in non-small cell lung cancer triggers $8.5M milestone payment

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.

“We are enthusiastic about advancing clinical research to Phase 2.”

"Efforts to advance development of SCH 900105, our lead antibody candidate, have been guided by our unique and proprietary Human Response Platform™, 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."

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