Bad news from Vertex

M

musclemania70

New member
Yes, the preliminary results from 661 are showing it to be much more effective than the 770/809.
It is good news because it means that they found a drug to be working at profound levels as the Kalydeco does for g551d.

Its bad news because there will be a longer wait for the drug that works for 508s.

Stay healthy people!
Keep what you've got and make it last!
 
M

musclemania70

New member
Yes, the preliminary results from 661 are showing it to be much more effective than the 770/809.
It is good news because it means that they found a drug to be working at profound levels as the Kalydeco does for g551d.

Its bad news because there will be a longer wait for the drug that works for 508s.

Stay healthy people!
Keep what you've got and make it last!
 
R

rmotion

New member
I talked to Vertex yesterday regarding the trial for 809, they said it is not enrolling any more. I asked why and now I know. She did say that I am on the list for the 661 study. Two steps forward one step back.
 
R

rmotion

New member
I talked to Vertex yesterday regarding the trial for 809, they said it is not enrolling any more. I asked why and now I know. She did say that I am on the list for the 661 study. Two steps forward one step back.
 
H

hmw

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i>

The unimpressive results from 809 were published 6 months ago. How are you surprised at all this? I don't get it.</end quote>
The results we received all those months ago were from an earlier phase of the trial, where people were given a lower dose of drug for a much shorter period of time. It was hoped that there would be better results during the next phase of the trial with higher dosages being given for longer periods of time. It has been those trial results everyone has been waiting for. I think we all realized the potential for problems with 809 but even at the CFF conference this fall they weren't giving up on it and were also planning for the possibility of needing two correctors to work together.

With all the speculation and conjecture that has been going around the last few months from all the people that have various contacts with CFF and/or Vertex sources, I wish Vertex would just release an official statement re the trial results so we'd all have the same info.
 
H

hmw

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>saveferris2009</b></i>

The unimpressive results from 809 were published 6 months ago. How are you surprised at all this? I don't get it.</end quote>
The results we received all those months ago were from an earlier phase of the trial, where people were given a lower dose of drug for a much shorter period of time. It was hoped that there would be better results during the next phase of the trial with higher dosages being given for longer periods of time. It has been those trial results everyone has been waiting for. I think we all realized the potential for problems with 809 but even at the CFF conference this fall they weren't giving up on it and were also planning for the possibility of needing two correctors to work together.

With all the speculation and conjecture that has been going around the last few months from all the people that have various contacts with CFF and/or Vertex sources, I wish Vertex would just release an official statement re the trial results so we'd all have the same info.
 
J

jmiller

New member
Does anyone recall when vx770 was originally projected to make it through trials?!? Seems like 2016 for 661 is a long time--- and that 770 went from phase 2 to approved much quicker...
 
J

jmiller

New member
Does anyone recall when vx770 was originally projected to make it through trials?!? Seems like 2016 for 661 is a long time--- and that 770 went from phase 2 to approved much quicker...
 
I

Incomudrox

New member
VX-770 has been more than 12 years in the making and thats just from when Vertex was formed (around 2001). The company that originally found the chemical compound was in the late 90s and then was merged with another company to make Vertex IIRC. The name of the other company started with an "A" but the name escapes me.
 
I

Incomudrox

New member
VX-770 has been more than 12 years in the making and thats just from when Vertex was formed (around 2001). The company that originally found the chemical compound was in the late 90s and then was merged with another company to make Vertex IIRC. The name of the other company started with an "A" but the name escapes me.
 
A

Anomie

New member
661 still has to go through two arms of a phase 2 trial that will take a year each to conduct and anylize and then an 18 month phase 3 trial. Tack on 6 months to that for the drug to gain FDA approval and that adds up to 4 years from now which will be 2016. VX 809 could have been approved in 2-3 years but it was farther along than 661. I really want to see them conduct a trial with all 3 drugs which is probably what they'll do if 661 isn't successful with kalydeco alone.
 
A

Anomie

New member
661 still has to go through two arms of a phase 2 trial that will take a year each to conduct and anylize and then an 18 month phase 3 trial. Tack on 6 months to that for the drug to gain FDA approval and that adds up to 4 years from now which will be 2016. VX 809 could have been approved in 2-3 years but it was farther along than 661. I really want to see them conduct a trial with all 3 drugs which is probably what they'll do if 661 isn't successful with kalydeco alone.
 
I

Incomudrox

New member
Anomie.... 809 and 661 are the same thing just metabolized differently. There will never be all three only two. 809 is getting axed.
 
I

Incomudrox

New member
Anomie.... 809 and 661 are the same thing just metabolized differently. There will never be all three only two. 809 is getting axed.
 
A

Anomie

New member
Well what about those articles in the news recently saying that correcting F508 will require a two fold approach. If thats true then we're gonna need another potentiator not even in the works yet. A new drug could take 10 years just to get to the point that 661 is at now. I saw the blog about the lady who experienced an 11% increase in FEV1 after a couple of weeks but are they also using sweat chloride as an endpoint? I'd really like to see some of those numbers get posted to re-assure us that 661 is going to be as effective on the double delta's as kalydeco was for G551D.
 
A

Anomie

New member
Well what about those articles in the news recently saying that correcting F508 will require a two fold approach. If thats true then we're gonna need another potentiator not even in the works yet. A new drug could take 10 years just to get to the point that 661 is at now. I saw the blog about the lady who experienced an 11% increase in FEV1 after a couple of weeks but are they also using sweat chloride as an endpoint? I'd really like to see some of those numbers get posted to re-assure us that 661 is going to be as effective on the double delta's as kalydeco was for G551D.
 
You must log in or register to reply here.
Top