New drug--Kalydeco--Approved

Anomie

New member
It is true that you can enter a search for vx 661 on the vertex website and turn up some old press releases stating that the drug will enter phase 2 clinical trials by the end of 2011. However its not listed on their drug candidates tab under medications and no study exists on the clinical trials government website for vx 661 trials. I have seen articles that say they will begin the trials in the first quarter of 2012 and other articles say middle of 2012. I just don't know whats causing the delay. The phase 2b vx809/770 trials seem to be temporarily held up for the moment as well; stuck in the recruiting phase for the last couple months. This could be because they just modified the trial to include people with only one copy of DF508 so maybe thats holding things up. I just wish I knew someone involved with the trials who could maybe give us a heads up. I seriously might just call them tomorrow and ask why vx661 and 809 are slowing down while 770 is just flying out of the gate.
 

Anomie

New member
It is true that you can enter a search for vx 661 on the vertex website and turn up some old press releases stating that the drug will enter phase 2 clinical trials by the end of 2011. However its not listed on their drug candidates tab under medications and no study exists on the clinical trials government website for vx 661 trials. I have seen articles that say they will begin the trials in the first quarter of 2012 and other articles say middle of 2012. I just don't know whats causing the delay. The phase 2b vx809/770 trials seem to be temporarily held up for the moment as well; stuck in the recruiting phase for the last couple months. This could be because they just modified the trial to include people with only one copy of DF508 so maybe thats holding things up. I just wish I knew someone involved with the trials who could maybe give us a heads up. I seriously might just call them tomorrow and ask why vx661 and 809 are slowing down while 770 is just flying out of the gate.
 
S

SarahProcter

Guest
I thought VX809 slowed to a crawl when the early results showed it didn't do much of anything? Am I misinformed?
 
S

SarahProcter

Guest
I thought VX809 slowed to a crawl when the early results showed it didn't do much of anything? Am I misinformed?
 

Anomie

New member
Thats what I'm afraid of. Vertex reported it as positive even though stock prices fell. The thing about the first part of the combo trial is that people were only on vx809 for 7 days. I know the next phase is going to include larger doses for longer periods but I think they're letting other mutations join the trial to see if its effective for anyone out there. Our doctor told us we may have to wait for all 3 drugs to be approved since they all work a little bit differently and the vx 809 might not be potent enough on its own.
 

Anomie

New member
Thats what I'm afraid of. Vertex reported it as positive even though stock prices fell. The thing about the first part of the combo trial is that people were only on vx809 for 7 days. I know the next phase is going to include larger doses for longer periods but I think they're letting other mutations join the trial to see if its effective for anyone out there. Our doctor told us we may have to wait for all 3 drugs to be approved since they all work a little bit differently and the vx 809 might not be potent enough on its own.
 
C

cfsucks

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>SarahProcter</b></i> I thought VX809 slowed to a crawl when the early results showed it didn't do much of anything? Am I misinformed?</end quote>

http://forums.cysticfibrosis.com/messageview.cfm?catid=5&threadid=608328&highlight_key=y&keyword1=vertex

found this post of yours. as another person stated it was a much shorter term study so the numbers are not comparable.
 
C

cfsucks

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>SarahProcter</b></i> I thought VX809 slowed to a crawl when the early results showed it didn't do much of anything? Am I misinformed?</end quote>

http://forums.cysticfibrosis.com/messageview.cfm?catid=5&threadid=608328&highlight_key=y&keyword1=vertex

found this post of yours. as another person stated it was a much shorter term study so the numbers are not comparable.
 

saveferris2009

New member
From the CFF website:

"In 2012, Vertex also plans to begin a Phase 2 clinical trial of Kalydeco in combination with another potential therapy, VX-661, in people with two copies of the Delta F508 mutation of CF."

http://www.cff.org/aboutCFFoundation/NewsEvents/2011NewsArchive/11-2-NEJM-Features-Kalydeco-Study.cfm
 

saveferris2009

New member
From the CFF website:

"In 2012, Vertex also plans to begin a Phase 2 clinical trial of Kalydeco in combination with another potential therapy, VX-661, in people with two copies of the Delta F508 mutation of CF."

http://www.cff.org/aboutCFFoundation/NewsEvents/2011NewsArchive/11-2-NEJM-Features-Kalydeco-Study.cfm
 
Top