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Saturday, January 25, 2014 12:59:41 PM
stockweiser, taking on Cotara to most big pharmas would be a bit like your town taking on building a nuclear reactor. Regulatory agencies. I131 has medical uses now, but mainly for taming overactive thyroids, and for some thyroid cancers. But how do you tell a patient they can't walk through an airport security scanner for 8 days after taking a medication? I am sure there are other issues with Cotara such as MAB size, immunogenicity (causing allergic reactions with multiple use), and possible bone marrow suppression, but these are only educated guesses and nothing I have seen in writing. I think a frank discussion of that technology is long overdue.
The possibility of an immune response to a biologic agent is present in all biologics. Certainly this data is gathered in the early clinical trials. I doubt there is a showstopper there.
The possibility of permanent damage to the immune system has often been brought up as a reason why MDs might be reluctant to use Zevalin and Bextar. No data to support that though, and there is some data (at least with Zev) to counter it. Of course Contara is a different drug. Also, I had suspected that GBM was chosen as the initial target to counter exactly this argument. The BBB works both directions.
As dumb as the "go through TSA" issue is, I kind of think that type thought is the real issue with the class.
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