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Curis, Inc. Message Board

  • jan31 jan31 Jul 11, 2013 10:57 AM Flag

    2013 Anticipated Milestones

    From Curis's Corporate Update, posted yesterday and presented at the JMP Healthcare conference. See Curis's website for the whole slideshow and to listen to the presentation.

     CUDC-427 (IAP antagonist) – multiple trial initiations
    • Phase 2 Breast cancer, combination with capecitabine: 3Q 2013
    • Phase 1/2 monotherapy, emphasis on ovarian cancer: July 2013
    • Phase 2 monotherapy, indolent and aggressive lymphoma: 2H 2013
     CUDC-907 (dual PI3K and HDAC inhibitor)
    • Phase 1 trial hematologic cancer readout: 4Q 2013
    • Initiation of Phase 1b solid tumor trial: 2H 2013
     Erivedge (hedgehog pathway inhibitor)
    • Approval in EU: 3Q 2013 (milestone payment to Curis)
    • Phase 2 operable BCC data: October 2013
     Debio 0932 (Hsp90 inhibitor)
    • Initiation of Phase 1/2 renal cell carcinoma study: 2H 2013
    • Presentation of HALO lung cancer trial results: 2H 2013

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    • just a reminder.

    • From Curis's new corporate update. Two milestones met (initiation of 427 monotherapy on ovarian and Euro approval), one milestone postponed to an irritatingly vague time window (operable BCC data pushed to 1H 2014 from October 2013). Old habits die hard. If they meet a couple more milestones, I'll be convinced that they are dying, though.

       CUDC-427 (IAP antagonist) – multiple trial initiations
      • Phase 2 Breast cancer, combination with capecitabine: 3Q 2013
      X Phase 1/2 monotherapy, emphasis on ovarian cancer: initiated in July 2013
      • Phase 2 monotherapy, indolent and aggressive lymphoma: 2H 2013
       CUDC-907 (dual PI3K and HDAC inhibitor)
      • Phase 1 trial hematologic cancer preliminary results: 4Q 2013
      • Initiation of Phase 1b solid tumor trial: 2H 2013
       Erivedge (hedgehog pathway inhibitor)
      • Launch in EU member states – royalties to Curis
      O Phase 2 operable BCC data: 1H 2014
       Debio 0932 (Hsp90 inhibitor)
      • Initiation of Phase 1/2 renal cell carcinoma study: 2H 2013
      • Results from Phase 1b monotherapy trial: 2H 2013

      • 1 Reply to jan31
      • Sorry I keep talking to myself:

        According to the CC the delay in operable results is "logistical." The conference in early Oct has an early due date that Roche couldn't meet given they are just seeing the data for the first time this week. Then next conference is Nov and they have submitted an abstract. It sounded like they would present the data there if the abstract is accepted, and later (at the beginning of 14) if not.

        So it has, according to Curis, nothing to do with the study or the data.

    • First milestone reached (on time!!):

      Curis Announces Initiation of a Clinical Trial of CUDC-427 In Advanced Malignancies

      LEXINGTON, Mass., July 25, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers, today announced dosing of the first patient in a Phase 1 dose-escalation study of CUDC-427 that is being conducted using a continuous, twice-daily oral dosing regimen in patients with advanced and refractory solid tumors or lymphoma. This trial builds on the single agent clinical results observed in the initial Phase 1 trial of CUDC-427, which were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2013. The primary objectives of the current study are to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of CUDC-427 using a more frequent dosing regimen. Additionally, the trial is designed to enroll up to 12 patients in an expansion cohort, which is expected to primarily include patients with ovarian and fallopian tube cancers. CUDC-427 is an oral, small molecule Smac mimetic drug candidate that selectively antagonizes inhibitor of apoptosis (IAP) proteins in cancer cells, resulting in induction of programmed cell death...

      Google the headllne for the rest.

 
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