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Posted: Thu Jun 05, 2008 9:06 pm Post subject: Novartis says FTY720 trial continues despite death
Novartis says FTY720 trial continues despite death
By Sam Cage
ZURICH, June 5 (Reuters) - Novartis AG (NOVN.VX: Quote, Profile, Research) said two patients taking its multiple sclerosis drug FTY720 in clinical trials had problems with infections and one died, but the role of the medicine in the cases was unclear.
Independent experts recommended that clinical trials with the drug -- which unusually for an MS medicine is taken orally -- should continue as planned, the Swiss drugmaker said on Thursday.
"Novartis was recently notified of two infection-related incidents among FTY720 patients, including one fatality," the company said in a statement.
Novartis shares closed 0.7 percent lower at 54.45 Swiss francs on Thursday, with traders citing rumours that FTY720 trials had been stopped on safety concerns. The Novartis statement was released after the Zurich bourse closed.
Rather than troll the internet for new information which could possibly be inaccurate, I had a brilliant idea. I called my study coordinator to get the info straight from the horse's mouth.
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Here is what she had to say:
One patient has contracted viral encephalitis and she is now in a coma.
The other patient had suffered a MS relapse and was put on steroids. She returned to work at a day care facility before it was recommended that she do so. She contracted chicken pox from a client. Due to her immune system being further compromised by the use of steroids, she ended up dying.
They are not at this time going to halt the study or the extension phase.
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Both patients had been on the study drug for nearly a year, starting this phase III trial in the summer of '07.
Novartis has not released whether these patients were on the Fingolimod or Placebo or Avonex.
My study coordinator was unsure whether they were both in the TRANSFORMS study or a different FTY720 study. The TRANSFORMS study has no placebo. You are either on Fingolimod or Avonex.
My instructions were to not worry, be vigilant about any infections I may get and inform the study nurse/neuro about them.
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... She said THAT is how I should always approach any type of new thing I become aware of...to tackle it head on, right away, and not take a wait and see stance.
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If I get any calls from the study people and have any more info to share, I'll be sure and post it.
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