A significant change: Prosensa/Glaxo now recruiting

Looks like its the kick off for Exon 51 trials

http://www.clinicaltrials.gov/ct2/show/NCT01153932?term=duchenne&am...

 

 

I noticed the number od participating kids increased from 54 to 66. Researchers must be pretty positive to increase the participation.

 

Fingers crossed.

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Hooray! Can't get enough of this good news. Thanks Tulika!!!
During the Action Duchenne conference last week, the GSK presenter said that 12 out of 50 boys in the Phase II study are already enrolled.

They will actually start a Phase III trial in other countries soon as well.
still not recruiting in the US?
Waiting for the FDA to open IND. They already sent the data requested, the IND is open aftre 30 days (if additional data si not requested which is very unlikely). Soon!



jenn said:
still not recruiting in the US?
Come on Phase III for USA!!!
im hanging on this trial, both the ambulatory (for my 8 year old) and the extension of the non ambulatory that austin was in this past summer. he asks all the time if we will get to do the trial that will help him this time (he knew the last was just a safety study). the docs at nationwide said they really think prosensa will run both trials as soon as they are allowed. i dont keep up on everything, but realisticly , ofelia, do you think we are looking at first quarter 2011 like they are still telling me? do you think the trial stands to be a 48 week trial?
Jenn,

For the ambulatory trial, I've heard from 2 of the principal investigators here in the US, they both said first quarter 2011. I think the same for the AVI trial, they said "by Spring 2011".

I did not ask about the non-ambulatory and the GSK guy just described the PK trial going on now in Columbus.

Ofelia



jenn said:
im hanging on this trial, both the ambulatory (for my 8 year old) and the extension of the non ambulatory that austin was in this past summer. he asks all the time if we will get to do the trial that will help him this time (he knew the last was just a safety study). the docs at nationwide said they really think prosensa will run both trials as soon as they are allowed. i dont keep up on everything, but realisticly , ofelia, do you think we are looking at first quarter 2011 like they are still telling me? do you think the trial stands to be a 48 week trial?
thanks ofelia, i sure hope so
Me too Jenn. Even tho skipping 51 doesn't help Alex in the short run...it helps ALL our guys in the long run. Just wish everyone can keep in the race for the long run. xox



jenn said:
thanks ofelia, i sure hope so

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