Tuesday, November 25, 2014 12:01:12 AM
Here's a good link discussing conversion of animal to human dosing:
dose translation from animal to human studies
Redoing the math for Cohort 9 using the forumulas from the above reference:
Cohort 9 dose is 350 mg/m2 (intravenous)
Mouse dose dramatically slowing tumor growth was 200 mg/kg (intraperitoneal)
Human Equivalent Dose in mg/kg= Animal dose (mg/kg) * Animal Km/ Human Km
HED Kevetrin= 350mg/kg * 3/37
= 28.38 mg/kg
Conversion of Cohort 9 dose from mg/m2 to mg/kg:
Cohort 9 Kevetrin= 350 mg/m2/37 = 9.46 mg/kg
So Cohort 9 Intravenous dose is 9.46 mg/kg. This dose is roughly equivalent to 0.54 the INTRAPERITONEAL dose of 17.43 mg/kg used in the mouse study. Intraperitoneal dosing will result in lower serum levels than intravenous dosing when comparing the same dose. I do not know the correlation coefficient for Kevetrin IP/IV but it seems to me (if I understand this correctly) that Cohort 9 serum levels are likely in the same ballpark as serum levels obtained with 350 mg intraperitoneal mouse dosing, especially if Kevetrin is dosed at near maximum tolerated dose twice weekly. Or even better by continuous infusion.
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