Tuesday, October 10, 2017 3:11:28 PM
Repeated many things:
- Didn't select for patients
- Effective with rGBM, prOC and Thyroid
- rGBM patient with 2 recurrences in complete response since 2013
Evidence of immune component due to immune reaction. Expect separation between two arms to be later. It takes time for immune system to activate - delay about 100 days.
DSMC decision based on safety and survival. Not allowed to stop trial early for efficacy because it's a single trial looking at survival under SPA. FDA agreed to put drug on the market based on SPA and they don't want to cut it any shorter.
Company is blinded but not patients and doctors.
Past approvals had 15-20% responders. Takes time to analyze final data.
Company *thinks* the data will be positive so they're building the new manufacturing facilities ($7 million).
If tumor is completely non-angiogenic, VB-111 has very little chance to work. Needs some angiogenisis to bring CD8 cell, immune system kicks in. Combining checkpoint inhibitor (won't work with limited mutations or immune system present ) with VB-111 (will bring CD8 cells into the tumor) will give checkpoint inhibitor better chance to work.
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