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Northwest Biotherapeutics, Inc. Message Board

  • itshuang itshuang Jun 13, 2013 9:56 AM Flag

    DCVAX-D trial

    Here's an email from the NWBO:

    "As planned for this quarter, we have begun our 60-patient Phase I/II Trial with DCVax-Direct for direct injection into inoperable solid tumors, with the first site being the renowned MD Anderson Cancer Center in Houston.

    Our DCVax-Direct product line is aimed at a broad range of currently untreatable, inoperable tumors. Patients in those situations today have few treatment options and little hope. The trial we have launched at MD Anderson will potentially be quite important in expanding those treatment options if it shows even a fraction of the tumor regression (shrinkage or eradication) seen in pre-clinical animal studies.

    Since the trial is not blinded, we anticipate seeing ongoing results through the course of this year.

    It's an exciting day for us, and we appreciate your continued interest in our progress."

    Sentiment: Strong Buy

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    • I agree. Given the company's cash position, we will hear ( if positive) results ASAP.

      My guess is NWBO already knows this works. I don't know the implications of "testing" being done on anything other than just mice but given it's safety profile, I'm guessing a few humans have already had this treatment outside a clinical trial which is why it's for "all solid tumors" instead of one or two indications.

    • From Seeking Alpha:
      "The treatment regimen calls for treatment on day 0, week 1, week 2, week 16 and potentially week 32 depending on the tumor response. The company believes results in most patients can be determined by week 8 or 16."

      Since this trial is not blinded, we should hear something within a few months.

      • 3 Replies to itshuang
      • when is it starting?

      • I think the results will come in much faster. Something we are not used to. I am talking 1 week to four weeks. This is how fast our immune systems work when properly activated against the tumors. No kidding. Phase 2 statistics will include many phase 1 patients as well, so we are likely to see a nearly simultaneous release. Because the patients are separated into smaller subgroups, and there are huge waiting lists to be in this trial, enrollment will be almost immediate.

        Its hard to imagine this, but it will be blindingly fast. I think NWBO knows this, but they have to be somewhat vague in order to reduce immediate expectations. Too late for me. I am expecting news in July! I am expecting the treatment to be approved in October and distributed in November.

      • I can't find this trial up on clinical trials site, anyone know whether it's been logged?
        Details on the trial design aren't easy to come by.
        Do we know when apherisis occurs? Pre-chemo draw and post-chemo administration (which would become 'Day 0')?
        We're looking at usually 4-6 cycles of chemo, so we'd need to take that into account once we're notified when enrollment begins.
        If that were the case, we're at least a couple of months away from any initial results so don't get cold feet if you don't hear anything for a while. Bio investors are a skittish bunch.

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