Hi MannyThey have definitely had signals of effectiveness - the...

Hi Manny

They have definitely had signals of effectiveness - the Complete and Partial Responses to date, plus the high levels of stable disease. I would suggest that his comment needs to be understood in the context - because it was in response to the question about ceasing dose escalation.

Dose escalation ceases for two reasons:

1. You hit a DLT (dose limiting toxicity) - which clearly hasn't happened

or

2. The clinical effectiveness levels out. ie. If you escalate the dose but there is no sign of additional effectiveness at the higher dose, then you drop back to the previous level and declare that as your Optimum Biologic Dose. In other words, when the rising effectiveness curve flattens out - that is your "signal" that further dose escalation is pointless.

I was thinking that the current dose level of 3 x 10⁸ is probably about where they will end up, as I suggested in an earlier post. Dr G indicated today that they may well go up another dose level, which take them to 1 x 10⁹. That implies to me that the current dose level of 3 x 10⁸ is indeed showing a significant additional effective compared to the previous step of 3 x 10⁷ - which is good news!

Of course, if they do go to 1 x 10⁹ and the additional effectiveness there is minimal, then they will drop back to 3 x 10⁸ and my prediction will turn out to be correct, but I don't think they will stop until they hit a DLT or see the effectiveness curve flatten out.

Cheers

Dave