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Re: DewDiligence post# 792

Friday, 01/09/2004 8:58:18 AM

Friday, January 09, 2004 8:58:18 AM

Post# of 257293
Dosing

Dew,

Not being a specialist of that field, you'll find below some guesses I can make:

-First, the dose they are using are strictly the one used during preclinical work. The usual game is to reproduce in phase I what you find on animal to prove your preclinical model is accurate and also to check on adverse events.
-Second, the replication rate is not 100%, there seem to be some kind of division factor and it is not linear, for example, if you inject 10 000 000, you get 100 and if you inject 1 000 000 000, you get 5000.
-Third, after 2 month, a parts of the vectors are absorbed, killed? by the organism. In preclinical trials, they found I cite "A dose dependent lost of vector genomes is seen between 3 hours and 15 days afetr administration. Interestingly, the amount of vector genome stabilizes after 15 days post administration at the same level for 60 days for each of the 3 doses"

Pharmacokinetics of viral vectors seem to be quite different than classical molecules.

Regards

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