Friday, August 14, 2015 2:25:23 PM
In the conference call Dror Harats said:
"We still have patients on the drug and we still have patients that we’re following at are alive on the arm that’s treated with VB-111 and then with the combination of VB-111 and Avastin. By the way on VB-111 alone all the patients are dead now or there is one patient left to follow up, so it has to be considered as dead."
1) "we still have patients that we’re following at are alive on the arm that’s treated with VB-111 and then with the combination of VB-111 and Avastin" .. This means that the overall survival (OS) rate -- last reported at 414 days -- will be greater when presented on 9/27. As it was reported, the OS rate was already statistically significant so the increased OS rate only makes it better but it doesn't change anything. This is why they are moving to Phase 3 already.
2) "on VB-111 alone all the patients are dead now or there is one patient left to follow up, so it has to be considered as dead" .. "VB-111 alone" really means "VB-111 monotherapy followed by bevacizumab monotherapy". All patients (except 1) have died and OS rate was 235 days. The 1 lone survivor is treated as an exception / outlier.
Phase 3: VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)
1) Instead of 46 patients (Phase 2), Phase 3 will be recruiting 252 patients with rGBM
2) Because the OS rate for Bevacizumab mono and combo therapies were established as 235 and 414 days, respectively, expect to hear an update in 4 to 7 quarters (365 to 455 days). So end of 2017 or beginning of 2018.
3) Phase 3 will either confirm / deny the results of Phase 2.
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