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Virgilio

04/30/17 3:52 PM

#115921 RE: jondoeuk #115919

I know, it seems that the control arm there significantly overperformed. The statistics of this PIII will IMO be particularly challenging, as for the trial design itself. So IMO either the mOS comes up really strong, or I see some real challenges in comparing the two arms, given the crossover.
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Milner1

04/30/17 5:09 PM

#115931 RE: jondoeuk #115919

Trial design is a mess. I too believe o/s of control is at 20+ months.

So its fail/fail

Sorry longs.
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f3tt3f

04/30/17 5:44 PM

#115935 RE: jondoeuk #115919

But Celldex's enrolment criteria is different. It's apples and oranges.
(No PsPD in DCVax, which are long tail survivors - they could have contributed to a longer control in Celldex)
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sentiment_stocks

04/30/17 7:26 PM

#115942 RE: jondoeuk #115919

Flipper made the point a hundred years ago that Celldex used KLH (keyhole limpet hemocyanin) in their control arm.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.
https://clinicaltrials.gov/ct2/show/NCT01480479



KLH is known to be an immune-stimulating antigen that is...

KLH is a highly effective T-cell dependent carrier protein that induces MHC Class I and Class II-restricted immune responses via antigen presenting cells. It is ideal in this role due to its immune-stimulating properties, large size, numerous sites for antigen conjugation, and safety profile. http://www.stellarbiotechnologies.com/science/the-power-of-klh



And that, along with other varied reasons, such as I believe psPDs were not excluded and rapid progressors were, may likely account for that higher 21.1 month number.