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Re: sox040713 post# 64777

Saturday, 08/09/2014 2:15:47 PM

Saturday, August 09, 2014 2:15:47 PM

Post# of 403039
If we assume that 200[mg kg^-1] mouse dose is also the magic dose for humans (big assumption), this 200 mouse dose is equal to a 16.67[mg/kg] human dose.

https://ncifrederick.cancer.gov/Lasp/Acuc/Frederick/Media/Documents/ACUC42.pdf

At 215[mg m^-2], we are effectively at 5.81[mg kg^-1]. Even if this became MTD, the capable dose does not end there. Analysis of the PK/PD data will inform a new dose schedule for future studies. For example, the body is shown to process the dose and allow a full dose to be administered every 2 days. Rather than 5.81[mg kg^-1] once per week, a simple increase to three doses per week puts us at 17.43[mg kg^-1] per 'dose' and we are then at an 'equivalent 209[mg kg^-1] mouse dose'. Efficacy!!! (given our first assumption above)

I think we're in a great position right now, even with all of the assumptions we make. Things are looking great for this Phase I.
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