Thursday, October 23, 2014 4:20:42 AM
* There is an implication that bavituximab is of little benefit. We don't know yet. We can assume the benefit is "less than stellar" as some put it, without high expectations, or we can assume a benefit of at least +30% to PFS and/or MOS. These are all assumptions until Yopp and PPHM come out with clear data.
* Directly related to the previous point. We'll get MOS when we get it, but I'm not exactly sure why a second Phase II would be needed if the current trial shows considerable benefit over historical sorafenib trials. Sorafenib is very well studied and as Yopp pointed himself out, more treatment options are needed. Again, maybe it's true a rigorous trial would work better, but if we don't see any benefit in this one, then it's very likely we wouldn't see it in a "better designed" Phase II trial.
* "not very many patients at 3.0 mg/kg" is strange because the dose escalation was done in Phase I with several people, and the 3.0 mg/kg dose should be given to everybody in the Phase II part of the study. It's more correct to say "not very many patients at 0.3 and 1.0 mg/kg"
3.0 mg/kg bavituximab and 400 mg bid sorafenib was determined to be safe in Phase I:
http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=3c696f2b-fe42-4706-a273-cd9ed475201f&cKey=13f80953-7730-4cd9-94bb-e438ca95cf5b&mKey=%7B2D8C569E-B72C-4E7D-AB3B-070BEC7EB280%7D
* Biopsy data is good, we don't know how valuable it's to MOA until we see the data on SITC
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