Innovation Pharmaceuticals Inc (IPIX)

[RJFL]

Sorry, hit submit post by mistake - full post below.

Hi Georgejjl - You raise some qood questions regarding dose conversions from mouse studies to humans. The FDA has suggested that it is appropriate to extrapolate animal dose to human dose by normalization of body surface area (BSA), which often is represented in mg/m2. To convert the dose used in a mouse study to a dose based on surface area for humans, one should multiply by 22.4 mg/kg (Baur’s mouse dose) by the Km factor (3) for a mouse and then divide by the Km factor (37) for a human. Since the Kevetrin mouse studies reference 200mg/kg the resultant calculation I believe would be 200x3/37, thus an equivalent dose would be 972 mg/kg when using the referenced formula. A good article on the topic is located here:

http://www.fasebj.org/content/22/3/659.full#ref-20

That said, the study above also notes the formula should be used because pharmacokinetics of absorption, distribution, and elimination parameters are considerations when dealing with also variables to consider when dealing with chemotherapy dosing, that is clearly not the case here, Kevetrin is restoring function of P53. It's above my pay grade to determine if the formula is pertinent with this type drug, thus we are depending on the expertise of Dr. Menon in this case,

I agree whole heartedly though that Kevetrin might best be used as a complementary drug to synergistically enhance efficacy, especially if used earlier in the disease process. Good questions to ponder. I'll close with the upbeat observation that it is extremely promising that disease stabilization/restaging was noted in some patients at low dosages, albiet in a small sample set.