along with markers indicating the likelihood of aggressive disease.
It fast became evident that he was, indeed, going to move along
quickly in his disease. Not wanting to go the chemo route, we
looked for a trial that as compared to chemo would be far less a
risk, when out of the blue came the MyVax trial. CLLers would be
started in a stage 2 trial, as NHLers had already successfully gone
through a stage 1 trial. By the time Kelly started in his stage 2
trial, the NHLers were midway in their stage 3 trial. This all
occurred before we knew of LDN.
The trial essentially consisted of 16 vaccine injections along with
leukine given over a 1 year period. Unlike other vaccines which
protect a person from a disease, the MyVax vaccine's duty was to
train the immune system over a period of time to recognize enemy
cells that were already present and to begin cell kill. It was
expected that while the vaccine part of the trial would last 1 year,
cell kill was not expected to occur till another 6 months had
passed. I should mention that the beauty of MyVax is that as
compared to chemo, the risks are quite low and in addition, harmless
to cells other than the cancer cells.
Now keep in mind that cell kill was not expected to begin occuring
till 18 months after the first injection. Meanwhile, the NHLers'
stage 3 trial ended last November. Despite the FDA knowing that no
reaction was expected for another 6 months, it demanded the
data/results from the NHL trial as of the completion of the trial,
despite the emploring of the manufacturer, which had invested years
and years in its hopes. Naturally, the data did not show cell kill,
although it did show that the immune systems of the participants HAD
reacted (become trained) to the vaccine. No amount of emploring
would affect the FDA and it denied approval based on incomplete data.
Now a company that worked so hard for so long, basing all its hopes
on this essentially innocuous vaccine, is going defunked, has
stopped its trial for the CLLers because it can no longer afford to
continue (stock holder issues), and thousands upon thousands of
NHLers and CLLers will no longer have the opportunity to use the
only conventional but fairly gentle treatment yet to be produced.
Yes, this is your FDA at work.
Jan - still hurting
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