vx 661 discussion moved

[hmw]

Phase 2a of the 809/770 trial showed the limited reduction in sodium chloride levels, etc- that is the press result that resulted in vertex stock dropping, if people remember due to results not meeting expectations. Phase 2b (the phase wrapping up now) involved a longer period on the meds and in larger doses to see if a better result would be obtained, enough to result in significant clinical results ...improved pulmonary function, reduced sweat tests, etc. Problems have been encountered with 809 and 770 interacting- this is known, not conjecture- whether they can overcome this I have no idea.

The major problem with waiting for this phase of 661 to decide which drug to move forward with would be that it has JUST started and is not estimated to be finished until August 2013, so hopefully they will be going by other data in making their decision.

 

[hmw]

Phase 2a of the 809/770 trial showed the limited reduction in sodium chloride levels, etc- that is the press result that resulted in vertex stock dropping, if people remember due to results not meeting expectations. Phase 2b (the phase wrapping up now) involved a longer period on the meds and in larger doses to see if a better result would be obtained, enough to result in significant clinical results ...improved pulmonary function, reduced sweat tests, etc. Problems have been encountered with 809 and 770 interacting- this is known, not conjecture- whether they can overcome this I have no idea.

The major problem with waiting for this phase of 661 to decide which drug to move forward with would be that it has JUST started and is not estimated to be finished until August 2013, so hopefully they will be going by other data in making their decision.

 

[Anomie]

Hmmm. So I'm guessing they won't know if 661 will reactly badly with 770 until they try upping the dose in the second phase of the trial. Or do they?

 

[Anomie]

Hmmm. So I'm guessing they won't know if 661 will reactly badly with 770 until they try upping the dose in the second phase of the trial. Or do they?

 

[musclemania70]

Vertex said 661 did not have the problems that were being seen with 809. That's what the man said. I didn't get his card. He said 809 will be continuing but if the 661 shows to be more effective at higher levels then they are scrapping the 809. That is exactly what he said. They are going to continue with the 809 right now because they need to finish the trial and have complete results. They don't want people on 809 giving up and throwing in the towel when they NEED THE DATA.
I think this all makes sense. Vertex holds the cards and we can't see 'em. CFF isn't gonna fold either.

 

[musclemania70]

Vertex said 661 did not have the problems that were being seen with 809. That's what the man said. I didn't get his card. He said 809 will be continuing but if the 661 shows to be more effective at higher levels then they are scrapping the 809. That is exactly what he said. They are going to continue with the 809 right now because they need to finish the trial and have complete results. They don't want people on 809 giving up and throwing in the towel when they NEED THE DATA.
I think this all makes sense. Vertex holds the cards and we can't see 'em. CFF isn't gonna fold either.

 

[Anomie]

Thank you for clearing that all up.

 

[Anomie]

Thank you for clearing that all up.

 

[Kristen]

I was wondering if she was going to have to delete her blog. My understanding is that people in a clinical trial can't share that info in a public forum, which is why people in clinical trials have always said, "PM me if you want more info" on here.

 

[Kristen]

I was wondering if she was going to have to delete her blog. My understanding is that people in a clinical trial can't share that info in a public forum, which is why people in clinical trials have always said, "PM me if you want more info" on here.

 

[Anomie]

Yeah, they don't want their investors to see what people are saying about the new drugs until they've verified everything and are ready to release a statement.

 

[Anomie]

Yeah, they don't want their investors to see what people are saying about the new drugs until they've verified everything and are ready to release a statement.

 

[hmw]

We had our cf education day at our hospital and a Vertex rep was there. I asked her what, if anything, she could tell us about the combo trials and when we were going to hear official news. She was, predictably, only able to tell us what we all already know; that they will continue forward with the drug that proves more effective of the two. That is not new information by any means if you attended the conferences held this fall/winter or listened to the podcasts of them etc. The press release containing the results of the 2b trial is expected to come this summer, also nothing new. Timetable 2016 if all goes perfect for 809 (pipe dream?), as repeated by the CFF person we had speak today. Nothing new.

She DID say that even if anyone at Vertex knew anything more than this, everyone working there signs agreements that they will not disclose this information. People in trials sign agreements that they will not disclose information. Doctors, clinical coordinators, nurses, etc involved in triala ALL sign this stuff- in other words, none of these 'sources' giving any information other than what is already info released by the CFF or by Vertex are supposed to be doing so and not only is it jeopardizing an individuals participation in the trial, if there's enough of it, it jeopardizes the ENTIRE TRIAL. She speculates that a lot of what's floating around is intentional vagueness colored by the perception of whoever hears it. Anyway, I sure didn't like the sound of people not being able to keep their mouths shut being able to jeopardize an entire trial process- for any med. I understand excitement (this waiting is driving me nuts!) but there's a reason it's all set up the way it is.

 

[hmw]

We had our cf education day at our hospital and a Vertex rep was there. I asked her what, if anything, she could tell us about the combo trials and when we were going to hear official news. She was, predictably, only able to tell us what we all already know; that they will continue forward with the drug that proves more effective of the two. That is not new information by any means if you attended the conferences held this fall/winter or listened to the podcasts of them etc. The press release containing the results of the 2b trial is expected to come this summer, also nothing new. Timetable 2016 if all goes perfect for 809 (pipe dream?), as repeated by the CFF person we had speak today. Nothing new.

She DID say that even if anyone at Vertex knew anything more than this, everyone working there signs agreements that they will not disclose this information. People in trials sign agreements that they will not disclose information. Doctors, clinical coordinators, nurses, etc involved in triala ALL sign this stuff- in other words, none of these 'sources' giving any information other than what is already info released by the CFF or by Vertex are supposed to be doing so and not only is it jeopardizing an individuals participation in the trial, if there's enough of it, it jeopardizes the ENTIRE TRIAL. She speculates that a lot of what's floating around is intentional vagueness colored by the perception of whoever hears it. Anyway, I sure didn't like the sound of people not being able to keep their mouths shut being able to jeopardize an entire trial process- for any med. I understand excitement (this waiting is driving me nuts!) but there's a reason it's all set up the way it is.

 

[Anomie]

The 28 day VX 661 trial is now complete and the results should be out by this summer. It was a really smart move by the foundation to have a back up to the vx 809.

 

[Anomie]

The 28 day VX 661 trial is now complete and the results should be out by this summer. It was a really smart move by the foundation to have a back up to the vx 809.

 

[hmw]

The current vx 661 trial has just started and is not estimated to be completed till August 2013.
The initial 28 day monotherapy w/ 661 is just the beginning. Depending on whatever they are looking for, it will go on to the next part of the trial- 28 more days of cotherapy with Kalydeco. Then of course is the information gathering etc and it is still recruiting etc.
http://clinicaltrials.gov/ct2/show/study/NCT01531673?term=Vx-661&rank=1

 

[hmw]

The current vx 661 trial has just started and is not estimated to be completed till August 2013.
The initial 28 day monotherapy w/ 661 is just the beginning. Depending on whatever they are looking for, it will go on to the next part of the trial- 28 more days of cotherapy with Kalydeco. Then of course is the information gathering etc and it is still recruiting etc.
http://clinicaltrials.gov/ct2/show/study/NCT01531673?term=Vx-661&rank=1

 

[mamaScarlett]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i> The current vx 661 trial has just started and is not estimated to be completed till August 2013. The initial 28 day monotherapy w/ 661 is just the beginning. Depending on whatever they are looking for, it will go on to the next part of the trial- 28 more days of cotherapy with Kalydeco. Then of course is the information gathering etc and it is still recruiting etc. http://clinicaltrials.gov/ct2/show/study/NCT01531673?term=Vx-661&rank=1</end quote>

Thank you Harriet for your<strong> accurate information</strong>!
It is imprortant to remember to be accurate to the T-even if a drug may or may not pan out...we need eligible patients to be in the trials to get us all closer to a drug that will help many of us.

 

[mamaScarlett]

<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i> The current vx 661 trial has just started and is not estimated to be completed till August 2013. The initial 28 day monotherapy w/ 661 is just the beginning. Depending on whatever they are looking for, it will go on to the next part of the trial- 28 more days of cotherapy with Kalydeco. Then of course is the information gathering etc and it is still recruiting etc. http://clinicaltrials.gov/ct2/show/study/NCT01531673?term=Vx-661&rank=1</end quote>

Thank you Harriet for your<strong> accurate information</strong>!
It is imprortant to remember to be accurate to the T-even if a drug may or may not pan out...we need eligible patients to be in the trials to get us all closer to a drug that will help many of us.