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ZIOPHARM Oncology, Inc. Message Board

  • rob_cos rob_cos Mar 22, 2013 10:24 AM Flag

    JPMorgan "We are optimistic... statistically significant improvement" Compelling data....

    We are optimistic that pali + doxorubicin can show an PFS vs. doxorubicin alone in the PICASSO 3 trial based on two main reasons:

    1. Compelling data from the PICASSO Phase 2 trial, along with encouraging
    single agent activity in refractory STS patients from a second Phase 2 trial. As a
    reminder, in PICASSO pali showed a statistically significant 3.4 month improvement
    in median PFS when added to doxorubicin, and a HR of 0.427 favoring the pali arm
    (p=0.019). Furthermore, the PFS result from PICASSO is even better when we look
    at patients censored for the effect of crossover to pali (HR of 0.396; p=0.023). We
    view these results as compelling and predictive of a positive PFS result for PICASSO
    3. In addition, pali has shown single agent activity in advanced, metastatic and/or
    unresectable STS patients following prior chemotherapy, with PFS rates that indicate
    activity when compared with historical controls for active agents. While we also
    view these findings as encouraging and suggestive of activity in STS, we note that
    this second Phase 2 trial was conducted in refractory STS patients (vs. frontline
    metastatic STS patients in PICASSO 3) and tested pali as a monotherapy without a
    control arm (vs. pali being tested in combination with doxorubicin vs. doxorubicin
    alone in PICASSO 3).
    2. PICASSO 3 has a very similar trial design as the successful Phase 2 PICASSO
    study. In fact, the PICASSO 3 study was designed as a close follow-on study to the
    Phase 2 PICASSO trial. Along with the compelling data for pali in STS from Phase
    2, this is fundamental as to why we believe there is a good probability of a successful
    outcome in PICASSO 3. There are a number of similarities in trial design, including:
    •PICASSO was well balanced for the stratification criteria, and the same criteria
    are being used in the Phase 3 PICASSO 3 study. As a reminder, patients in Phase
    2 were stratified by 1) age ( 65 vs.

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