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Tuesday, 26 June 2018

Poliovirus (PVS-RIPO) phase 1 update

Thanks to Al Musella for bringing this to our attention.

https://virtualtrials.com/news3.cfm?item=6529  (Al's commentary)

https://www.nejm.org/doi/full/10.1056/NEJMoa1716435  (full study, HTML)

https://www.nejm.org/doi/pdf/10.1056/NEJMoa1716435   (PDF download)

Here, as in some other viral therapy/immune therapy trials, we're seeing a long tail of survivors, in this case 21% surviving to 2, 3, 4 and 5 years (all dose levels).  This is comparable to DNX-2401 phase 1 trial, where 20% survived at 3 years, or Toca 511 + FC (13% alive at 3 years, all dose levels).

The most intriguing part of the study is the observation that some of the patients had dramatic responses to chemotherapy (including lomustine) after treatment with the modified poliovirus.  The randomized phase 2 trial open now is testing poliovirus alone versus poliovirus + single course lomustine.

This trial is open and Duke, and soon to open at Massachusetts General, UCSF, and Boca Raton.

https://clinicaltrials.gov/ct2/show/NCT02986178
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7 comments:

  1. Mike26 June 2018 at 12:37

    Seems like very good news- thanks Stephen!

    So of the recent trial updates that have shown long tails (DCVax,Polio,Optune w/90% compliance,Toca), is the Polio trial the only one that is based on a rGBM study?

    Mike B

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    1. Stephen W26 June 2018 at 14:26

      Toca 511 + FC was also mostly recurrent GBM (though there was a few anaplastic astrocytoma) and DNX-2401 was recurrent GBM.

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    2. Stephen W26 June 2018 at 14:29

      And if you only look at the high dose Toca 511 patients (n=23), 3 years survival increases to 26% (versus 13.4% for all doses).

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    3. Unknown27 June 2018 at 02:26

      Mike, Stephen
      Is TOCA can be effective to take before the recurrent GBM (I mean, after the surgery , and while using optune?)



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    4. Stephen W27 June 2018 at 09:34

      It could be effective, but the only way to get access is to join a clinical trial, and for the clinical trial the tumor would have to be progressive/recurrent.

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  2. Unknown27 June 2018 at 02:23

    Hello,
    My father is from Israel. is there any way he can benefit from the Poliovirus?
    Or is it hard to get and still very very early

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    1. Stephen W27 June 2018 at 09:32

      The phase 2 trial is only open at Duke University. I've heard that Duke clinical trials only accept patients with insurance coverage in the USA. The trial will be opening soon at a few other locations in the USA (Massachusetts General, UCSF, Boca Raton) and I'm not sure if the policy will be the same there.

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