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Northwest Biotherapeutics, Inc. Message Board

  • g_noh g_noh Nov 22, 2013 11:49 AM Flag

    Phase 3 for Prostate Cancer

    Doing my dd before possibly buying on Monday. Any thoughts on why company can't find a company to partner a phase 3 trial for prostate when the potential market is so large and the money necessary is relative small... Around $70 million. Keep in mind FDA gave approval some six years ago.

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    • Just to add....not something that's new, but germane to our discussion here. From Les Goldman's mail yesterday... (emphasis mine)

      "Given the quickening pace of the Phase III GBM trial in the US and Europe, as well as the Phase I/II DCVax-Direct trial in the US for all inoperable and untreatable solid tumor cancers, this encouraging raise puts the Company in an even stronger position to execute on our numerous programs directed at MULTIPLE cancers all based on the SINGLE DCVax platform."

      Sentiment: Strong Buy

    • noh, the current focus of the NWBO team is on the two DCVax lines. There has been quite a bit of enhancement of the DCVax platform over the past few years and the patents filed recently point to that progress. It is quite likely that the DCVax platform, with some cancer-specific tweaks, might one day be extended to treat prostate cancer. Linda had said in one of her presentations this year that the DCVax-L line, if successful, can potentially be extended to cancers beyond GBM (that's also perhaps the reason they changed the name of the vaccine from DCVax-Brain to the more generic DCVax-L (L being tumor lysate)). This may or may not be applicable for prostate cancer, but look at the following from Dr. Marnix Bosch's presentation on DCVax-Direct at the Weill Cornell Brain Tumor Biotech Summit on the 7th of June, this year.....

      Potential indications: all non-resectable (inoperable) solid tumors, such as:
      o Liver cancer
      o Liver metastases of colon cancer
      o Head and neck cancer
      o Esophageal cancer
      o Prostate cancer
      o Other cancers

      Note the mention of prostate cancer above.

      Where DCVax-Prostate currently helps is in providing yet another validation of the potential efficacy of the DCVax platform. So, in Phase I trials in GBM, Phase I trials in Prostate Cancer, Phase I trials in Ovarian Cancer with UPenn., and in pre-clinical trials in DCVax-Direct, not only has the DCVax platform shown efficacy, the degree of efficacy too has been striking and consistent.

      Despite all this, it is entirely possible, even likely I think, that the FDA insists on a full Phase III for DCVax-Prostate. But rest assured that if DCVax-L and DCVax-Direct work, then neither funding nor enthusiasm will not be found wanting for that effort.

      Sentiment: Strong Buy

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