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Re: walldiver post# 1035

Saturday, 09/16/2006 2:05:38 AM

Saturday, September 16, 2006 2:05:38 AM

Post# of 12660
When asked by the CBER Advisory Committee in February why CD54 was chosen as a potency marker for Provenge and why it should be correlated with long term survival, DNDN's Dr. Provost replied in a self deprecating manner that perhaps DNDN was just lucky.

Luck seldom figures in this sort of things - just lots of grunge work. Dr. Urdal discussed the antigen cassette technology and the role of CD54 at the Workshop on Tumor Vaccines in 1998. He'll likely talk about the CD54 data from the trials in the Cell & Gene Therapy Forum in Baltimore in Jan 2007.

http://www.fda.gov/CbER/minutes/tumor121098.pdf

"Now what I'd like to suggest in the next
couple of slides is an alternative way of actually
looking at some of the co-stimulatory markers and
their expression and picked CD-54 by means of
example, that it not only serves as a means by which
we can quantify dendritic cells that have been
induced to maturate in these cultures, but it's also
a marker that is associated with the potency and
capacity of these cells to actually interact with
naive T-cells."

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