Novartis says FTY720 trial continues despite death : Drug Pipeline - This Is MS Multiple Sclerosis Community: Knowledge & Support

View unanswered posts | View active topics

Board index » Multiple Sclerosis » Drug Pipeline

All times are UTC - 8 hours [ DST ]

Novartis says FTY720 trial continues despite death

Page 1 of 1

[ 2 posts ]

Print view

Previous topic | Next topic

Author

Message

rainer

Post subject: Novartis says FTY720 trial continues despite death

Posted: Thu Jun 05, 2008 8:06 pm

Family Elder

Joined: Thu Jan 17, 2008 4:00 pm
Posts: 367

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.

http://www.reuters.com/article/companyN ... 2720080605

Top

CureOrBust

Post subject:

Posted: Sat Jul 05, 2008 6:15 am

Family Elder

Joined: Wed Jul 27, 2005 3:00 pm
Posts: 2735
Location: Sydney, Australia

I do not know if this is accurate, but its further information.
http://fty720.blogspot.com/2008/06/update-on-fingolimod-fty720-death-and.html

Quote:

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.

Quote:

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.

Quote:

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.

Quote:

... 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.

Quote:

If I get any calls from the study people and have any more info to share, I'll be sure and post it.

Top

Page 1 of 1

[ 2 posts ]

Board index » Multiple Sclerosis » Drug Pipeline

All times are UTC - 8 hours [ DST ]

Topics		Author	Replies	Views	Last post
Related topics
	FTY720 trial	bromley	0	1086	Wed Sep 28, 2005 5:20 am bromley
	end of my FTY720 phase lll trial and beginning of ...	carolew	9	1915	Thu Dec 11, 2008 8:23 am carolew
	FTY720 Trial for PPMS took an interesting turn today	Smilingface	3	1904	Sat May 16, 2009 10:27 am dignan
	Novartis Gilenya MS Pill to Cost $48,000 a Year	dreddk	13	3783	Sat Jun 04, 2011 12:30 pm mrbarlow
	DEATH Tysabri Patient	Rici	0	1184	Sun Aug 12, 2012 2:06 pm Rici

Who is online

Users browsing this forum: No registered users

You cannot post new topics in this forum
You cannot reply to topics in this forum
You cannot edit your posts in this forum
You cannot delete your posts in this forum

Jump to: