Jumat, 18 April 2008

Re: [cancercured] Speaking of the FDA

MyVax was just another commercial attempt at a vaccine that was
doomed to failure. The basic science using a KLH conjugate with
GM-CSF is a good one if an appropriate target is selected and if the
patient has not had immunosuppressive chemotherapy. The company was
attempting an overly complex and time-consuming method to make the
conjugate. It was not only unlikely to work (with its abstruse
"proprietary technology") but it was extremely unlikely to be
approved by the FDA. The government approves monoclonal antibodies,
not treatment vaccines. If the company was on the up an up with its
investors they would have picked any number of cancers with an
off-the-shelf target such as those cancers with easily monitored
blood tumor markers. If the FDA would only allow trials after
chemotherapy, then the company could counter by admitting only those
candidates who had vincristine, bleomycin, and perhaps gemcitibine,
i.e., the chemos that would be far less likely to undermine a
treatment vaccine.

Vincent


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