20 tons of safflower is not tons of commercial grade product
Agreed. But I believe that refers to the seed, where the ApoA1 is concentrated and although I can't find the documentation, I think I recall a claim that the genetically modified safflower has been induced to produce around 10% apoA1 milano by weight. If that is correct, 20 tons is a boatload of raw material---and there is a lot more where that came from.
To put these figures in some context, the Esperion studies using ETC-642 seem to be using 10-30 mg/kg (about 1-2 gm) single doses in their phase 1 studies. That dose seems to produce clinically measurable effects 30 days later.
This comes from the SemBioSys web site, corroborating the same dose range:
If successfully commercialized, predicted high
dosing (multiple grams per course of patient treatment) coupled with a large
patient population would be expected to drive volume demand of several tons of
Apo AI(Milano) per year, underscoring the value of a highly scalable, plant
manufacturing solution
Urche
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