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     220  0 Kommentare Spectrum Pharmaceuticals Provides Poziotinib Update - Seite 2

    Conference Call Details:

    Wednesday, December 19, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific

    Domestic: (877) 837-3910, Conference ID# 1577888
    International: (973) 796-5077, Conference ID# 1577888

    The conference call will also be webcast live. To access the webcast, please visit the Investor Relations page of the Spectrum Pharmaceuticals website at http://investor.sppirx.com/events-and-presentations.

    For interested individuals unable to join the call, a replay will be available from December 19, 2018 @ 7:30 p.m. ET/4:30 p.m. PT through December 26, 2018, until 7:30 p.m. ET/4:30 p.m. PT.

    Domestic Replay Dial-In: (855) 859-2056, Conference ID# 1577888
    International Replay Dial-In: (404) 537-3406, Conference ID# 1577888

    About Poziotinib

    Poziotinib is a novel, oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumors.

    About ZENITH20

    The ZENITH20 study is Spectrum-sponsored, Phase 2, open-label, single-arm, multi-center, global study for patients with EGFR or HER2 exon 20 insertion mutations in NSCLC. It consists of four cohorts, each of which is an independent study with pre-specified statistical hypotheses and statistical power. There are two cohorts in the previously-treated setting and two in the first-line setting. The full poziotinib targeted therapy clinical program is focused on four development areas for EGFR and HER2 mutations, including previously treated NSCLC, first-line NSCLC, treatment of other solid tumors and combination therapy.

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    Spectrum Pharmaceuticals Provides Poziotinib Update - Seite 2 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), today announced that based on a subset of data from MD Anderson’s ongoing Phase 2 study, the U.S. Food and Drug Administration (FDA) did not grant Breakthrough Therapy Designation (BTD) to poziotinib …