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ZIOPHARM Oncology, Inc. Message Board

  • rob_cos rob_cos Mar 19, 2013 11:31 AM Flag

    SCLC showing better early results than expected imo.....

    {{MUCH EASIER TO READ FULL VERSION OF POST ON Investorvillage ZIOP board - yahoo cut my post below off and does not show bold or highlight - guys go to IV ZIOP board.}}

    Its pretty clear that this open label SCLC trial are showing good results & Drs are spreading word to lung cancer colleagues resulting in 150 patients on drug MUCH faster than expected. First DMC review resulted in continued trial....

    Press release expanded on the quick comment Lewis made last week - that the independent DMC overseeing Pali SCLC trial continued it after reviewing the first 20 patients who received two cycles....this plus the comments below from the Barclays transcript showing 150 patients on drug twice as quickly as I expected to me means the Doctors who had the early patients on drug are seeing positive results and they are calling their colleagues and getting them to put more patients on. REMEMBER THIS IS AN OPEN LABEL TRIAL SO RESULTS ARE KNOWN ON THOSE EARLY PATIENTS. Lewis said at Barclays: "This trial is enrolling ahead, quite far ahead of projection. And so as of this time, there are about 150 patients randomized, and this is going very quickly. The first IDMC review of 20 patients were successful". SCLC is a tough disease โ€“ so nothing is guaranteed in that indication โ€“ but clearly early signs are better than I expected. If this drug works in SCLC (nothing approved in over 30 yrs in that indication โ€“ exploding SCLC patient numbers worldwide especially in Asia), this one indication imo is worth more than the current market cap net of cash.

    Excerpt from PR from yesterday (yahoo cut off - see reply for full PR excerpt)

    ...pivotal Phase 3 trial (MATISSE) small cell lung cancer....After 20 patients received at least two chemotherapy cycles, the study's Independent Data Monitoring Committee conducted an analysis of safety data and recommended that the trial proceed as planned. Enrollment is ongoing and remains ahead of projections.

    Sentiment: Strong Buy

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    • Excerpt on SCLC from Lewis Barclays presentation last week....

      I'm now going to shift to the second randomized Phase III, and that is in small cell lung cancer. This is a study, a concept, that came about through Dr. Larry Einhorn. Einhorn is the former head of the Indiana Cancer Center. He is the individual who got ifosfamide FDA approved and he is the individual who took testicular cancer from most people dying to most people being cured.

      In small cell lung cancer, there's a very high unmet need. It has been very difficult to get any kind of movement there with any new drug. There's been no innovation in decades. It's a large market opportunity both in the U.S. and, of course, outside the U.S. and the rationale here from Einhorn and his colleagues in Indiana, and the Hoosier Oncology Group, was the following: and that is based on the study with ifosfamide in the 1990s, in the first-line setting and they showed a benefit when it was added to standard care, this was a randomized study with survival as an endpoint.

      Indeed, this is the only study ever done outside of Japan that has shown a benefit and a difference as regards survival in small cell lung cancer, compared to standard care. The reason it never took off is because of the excessive toxicity, a marked toxicity of ifosfamide.

      And so what Einhorn did, together with his colleagues, is approach us and did a Phase I study, again, in Indiana in the Hoosier Oncology Group, adding palifosfamide to standard care and showed a high degree of success in patients, who are very refractory, with the combination being well tolerated. And this was specifically in small cell lung cancer, but in addition, based to similar kinds of effects in germ cell tumors, both testicular and ovarian, which was promulgated, again in the India University-sponsored study. And indeed, similar effects in a few patients with sarcoma. It's a clear activity being seen when added in this combination.

      The Phase III study that is being don

      • 1 Reply to rob_cos
      • The Phase III study that is being done is called MATISSE. It's an adaptive design. It's adaptive design were off through 125 events. There'll be an interim look by an independent committee and the trial will either continue with different sizes, continue with different powering assumptions or be stopped because at the top end, there'll be efficacy or at the bottom end, there'll be futility.

        Again, this will be done by an independent committee and the goal here being to optimize the chances of success based on data. This trial is enrolling ahead, quite far ahead of projection. And so as of this time, there are about 150 patients randomized, and this is going very quickly. The first IDMC review of 20 patients were successful. And again, this interim analysis of 125 events is expected at the end of this year.

        Shown here is the market potential, with various numbers, various data. And again, based on the current projections, as regards soft tissue sarcoma, small cell lung cancer, for the U.S. it's estimated that there'll be greater than 1 billion in terms of cell recipients. As we get to the global market, the potential becomes a whole lot higher

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