NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

That is a good point, imo. It is in reference to this "Ph I/II trial" specifically, and so cannot exclusively be talking about the preclinical mice data. There must be something about that as it's being seen in humans in this trial. Otherwise, the wording would have been different. This trial is specifically set up to view tumor necrosis or not. That is the main endpoint. Systemic effect is an aside (though, much hoped for aside). It simply does not have a place in the title unless it is being seen in the patients. Not in regards to this trial (again, if even a secondary ep was systemic effect, then yes I would say they are in a way obligated to state it in the title, but in this case they are not).

"The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the treatment of solid tissue tumors will be identified, followed by a Phase II component to determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability to reduce tumor growth."

and

Primary Outcome Measures:

-Number of patients with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]


Secondary Outcome Measures:

-Number of patients with tumor response [ Time Frame: 18 months ] [ Designated as safety issue: No ]


Other Outcome Measures:

-Number of patients surviving [ Time Frame: 24 months ] [ Designated as safety issue: No ]
-Number of patients surviving without tumor progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]