vx 661 discussion moved

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Anomie

New member
It looks like all of the info relating to the vx 661 trials has been removed from that girls blog shortly after I posted the link on another thread last night. That thread broke down so I started a new one here.
MamaScarlett, if you read this will you please post the link to the cff press release concerning the vx 809 trials. The only thing I could find on their website from 2012 was about the release of kalydeco.
Thanks
 
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Anomie

New member
It looks like all of the info relating to the vx 661 trials has been removed from that girls blog shortly after I posted the link on another thread last night. That thread broke down so I started a new one here.
MamaScarlett, if you read this will you please post the link to the cff press release concerning the vx 809 trials. The only thing I could find on their website from 2012 was about the release of kalydeco.
Thanks
 
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musclemania70

New member
The press release is not specific enough to make judgements about the status of the 809 or 661. As usual, they are very vague and don't go into detail. I suppose only Vertex is going to be the press release that we want to see. They will be more specific about the drugs and their progress. Interesting why the information on her blog was removed... I suppose if you agree not to publicize results, then she was in error.
 
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musclemania70

New member
The press release is not specific enough to make judgements about the status of the 809 or 661. As usual, they are very vague and don't go into detail. I suppose only Vertex is going to be the press release that we want to see. They will be more specific about the drugs and their progress. Interesting why the information on her blog was removed... I suppose if you agree not to publicize results, then she was in error.
 
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mamaScarlett

Active member
Yes it is vague which is irritating.
But there is no information about the trial being canceled whatsoever, as was recently posted here. From the paragraph on 809 and 661:

Later this year we expect to have results from the second part of the Phase 2 trial of Kalydeco and VX-809 in those with the Delta F508 mutation. This is a very important trial; nearly 90 percent of people with CF have the Delta F508 mutation.
Results from the first part of this Phase 2 trial showed that those who received the two drugs together had a decrease in sweat chloride levels — a sign that the combination treatment is having an effect on the root cause of the disease.
Vertex is also testing Kalydeco together with another potential drug, VX-661, in people the most common mutation. These studies could lay the groundwork for future clinical research using a combination therapy approach.
 
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mamaScarlett

Active member
Yes it is vague which is irritating.
But there is no information about the trial being canceled whatsoever, as was recently posted here. From the paragraph on 809 and 661:

Later this year we expect to have results from the second part of the Phase 2 trial of Kalydeco and VX-809 in those with the Delta F508 mutation. This is a very important trial; nearly 90 percent of people with CF have the Delta F508 mutation.
Results from the first part of this Phase 2 trial showed that those who received the two drugs together had a decrease in sweat chloride levels — a sign that the combination treatment is having an effect on the root cause of the disease.
Vertex is also testing Kalydeco together with another potential drug, VX-661, in people the most common mutation. These studies could lay the groundwork for future clinical research using a combination therapy approach.
 
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hmw

New member
I think you do have to agree not to share info that specific (i.e. fev1). You aren't even told what your numbers are when they are done at clinic. And it does kind of make sense to me, as frustrating as it is (I am just as curious as everyone else!) If everyone is sharing their info it starts taking away from objectivity of the process. And really, she has no idea if she is on drug or placebo, experiencing legitimate therapeutic effects from medication or not. Oh how I hope she is- odds are definitely in her favor.

Anyway, I think clinical trials have always been that way though re sharing info... it's not something new.
 
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hmw

New member
I think you do have to agree not to share info that specific (i.e. fev1). You aren't even told what your numbers are when they are done at clinic. And it does kind of make sense to me, as frustrating as it is (I am just as curious as everyone else!) If everyone is sharing their info it starts taking away from objectivity of the process. And really, she has no idea if she is on drug or placebo, experiencing legitimate therapeutic effects from medication or not. Oh how I hope she is- odds are definitely in her favor.

Anyway, I think clinical trials have always been that way though re sharing info... it's not something new.
 
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hmw

New member
I agree, mamaScarlett. All the people who have 'sources' telling them that once 2b is done that 809 is being scrapped clearly have sources speaking out of turn- even if they know it's fact, they aren't supposed to be leaking this info prior to the official Vertex press release, and it drives me crazy that it will remain conjecture for some time yet.

I don't think there is any question that the 2b will be finished- those assured that THIS trial is not being scrapped are absolutely correct. Have THEY been told anything about a phase 3 is the real question.
 
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hmw

New member
I agree, mamaScarlett. All the people who have 'sources' telling them that once 2b is done that 809 is being scrapped clearly have sources speaking out of turn- even if they know it's fact, they aren't supposed to be leaking this info prior to the official Vertex press release, and it drives me crazy that it will remain conjecture for some time yet.

I don't think there is any question that the 2b will be finished- those assured that THIS trial is not being scrapped are absolutely correct. Have THEY been told anything about a phase 3 is the real question.
 
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mamaScarlett

Active member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i> I agree, mamaScarlett. All the people who have 'sources' telling them that once 2b is done that 809 is being scrapped clearly have sources speaking out of turn- even if they know it's fact, they aren't supposed to be leaking this info prior to the official Vertex press release, and it drives me crazy that it will remain conjecture for some time yet. I don't think there is any question that the 2b will be finished- those assured that THIS trial is not being scrapped are absolutely correct. Have THEY been told anything about a phase 3 is the real question.</end quote>
Exactly. Everyone's vagueness is driving me nuts!
Here's my question, and perhaps it sounds elementary, but why in the world would they scrap this and not proceed with a phase 3 when they are saying this about this drug?-
"<span>Results from the first part of this Phase 2 trial showed that those who received the two drugs together had a decrease in sweat chloride levels — a sign that the combination treatment is having an effect on the root cause of the disease. "
???
 
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mamaScarlett

Active member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i> I agree, mamaScarlett. All the people who have 'sources' telling them that once 2b is done that 809 is being scrapped clearly have sources speaking out of turn- even if they know it's fact, they aren't supposed to be leaking this info prior to the official Vertex press release, and it drives me crazy that it will remain conjecture for some time yet. I don't think there is any question that the 2b will be finished- those assured that THIS trial is not being scrapped are absolutely correct. Have THEY been told anything about a phase 3 is the real question.</end quote>
Exactly. Everyone's vagueness is driving me nuts!
Here's my question, and perhaps it sounds elementary, but why in the world would they scrap this and not proceed with a phase 3 when they are saying this about this drug?-
"<span>Results from the first part of this Phase 2 trial showed that those who received the two drugs together had a decrease in sweat chloride levels — a sign that the combination treatment is having an effect on the root cause of the disease. "
???
 
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Anomie

New member
Its because the average drop in sweat chloride was less than they had hoped for even though some patients experienced significant decreases. I'm just speculating here but they may be planning to scrap 809 after the phase 2b trial if vx 661 out performs in its current phase 2a trial. This is obviously not something they'd want to share with the general public but it would make sense. I wish that who ever started this rumor would come forward and share their source or there's really no point in discussing it anymore.
 
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Anomie

New member
Its because the average drop in sweat chloride was less than they had hoped for even though some patients experienced significant decreases. I'm just speculating here but they may be planning to scrap 809 after the phase 2b trial if vx 661 out performs in its current phase 2a trial. This is obviously not something they'd want to share with the general public but it would make sense. I wish that who ever started this rumor would come forward and share their source or there's really no point in discussing it anymore.
 
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Anomie

New member
BTW: All of the posts from the girl's blog still appear to be deleted. If you have found them then please post the link.
 
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Anomie

New member
BTW: All of the posts from the girl's blog still appear to be deleted. If you have found them then please post the link.
 
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