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Oren1976

04/23/17 3:28 PM

#855 RE: gr8db8 #854

It's a huge mistake to make the ph3 different from a successful phase 2 can u explain why ? I m telling u all this change will blow everything. It can even cause not reaching endpoint and even if they meet the results will be poor. Why to change ? Is there a reason?

davidal66

04/23/17 3:33 PM

#856 RE: gr8db8 #854

You can also look at the phase II trial and compare it to the GLOBE trial in another way entirely. The overall survival for the limited cohort, those who progressed on VB-111 and switched over to Avastin was about 8 months. The continuous cohort, those who, upon progression on VB-111, continued with VB-111 and Avastin was about 15 months. Add up those 46 patients, dive them by two, you arrive at 11.5 months overall survival, maybe slightly high since there were two more patients on the continuous arm... 24 versus 22.

So, in looking at the trial of how high dose VB-111 does in rGBM, you have an average overall survival of about 11.5-12 months.

Now, compare this number to the historical Avastin numbers of around 8 months, although some trials are actually under 32 weeks, some over 32 weeks.

So, you could have a trial success of 8 months OS Avastin versus 11 VB-111 months overall survival versus a trial failure of 9.5 months OS Avastin versus 10.5 months OS VB-111 which fails to hit significance.