You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an alternative browser.
You should upgrade or use an alternative browser.
VX 809/770 Phase 2 interim results - 5-10% improvement in lung function
- Thread starter jamesB
- Start date
James, Kalydeco (VX-770) achieved results of a 10.5% mean absolute improvement in its phase 3 trial, not 20% as mentioned above. This trial was also a far longer trial (48 weeks) compaerd to the recent 809/770 phase II trial. Unfortunately, the phase 2 study of VX-770 in G551 did nt use lung function increase as a marker and therefore it is not possible to compare the two trials.
Having listened to the conference call yesterday, the whole point of this announcement was that they could get the ball rolling with regulatory requirements. Vertex no have experience of this with Kalydeco and I would hope this could help reduce the time to approval (all being well). I would like to think the trial would take 18 months to complete from its start point (presumably the latter part of this year) and another 6 months for approval.
Having listened to the conference call yesterday, the whole point of this announcement was that they could get the ball rolling with regulatory requirements. Vertex no have experience of this with Kalydeco and I would hope this could help reduce the time to approval (all being well). I would like to think the trial would take 18 months to complete from its start point (presumably the latter part of this year) and another 6 months for approval.
James, Kalydeco (VX-770) achieved results of a 10.5% mean absolute improvement in its phase 3 trial, not 20% as mentioned above. This trial was also a far longer trial (48 weeks) compaerd to the recent 809/770 phase II trial. Unfortunately, the phase 2 study of VX-770 in G551 did nt use lung function increase as a marker and therefore it is not possible to compare the two trials.
Having listened to the conference call yesterday, the whole point of this announcement was that they could get the ball rolling with regulatory requirements. Vertex no have experience of this with Kalydeco and I would hope this could help reduce the time to approval (all being well). I would like to think the trial would take 18 months to complete from its start point (presumably the latter part of this year) and another 6 months for approval.
Having listened to the conference call yesterday, the whole point of this announcement was that they could get the ball rolling with regulatory requirements. Vertex no have experience of this with Kalydeco and I would hope this could help reduce the time to approval (all being well). I would like to think the trial would take 18 months to complete from its start point (presumably the latter part of this year) and another 6 months for approval.
R
rainsmom
Guest
the release said the sweat chloride.. not statistically significant on those using vx809 and kalydeco but then goes on to say there was a significant reduction in those that were treated with vx 809 alone. so what does that mean exactly? does the kalydeco change the way it works? that seemed confusing to me
R
rainsmom
Guest
the release said the sweat chloride.. not statistically significant on those using vx809 and kalydeco but then goes on to say there was a significant reduction in those that were treated with vx 809 alone. so what does that mean exactly? does the kalydeco change the way it works? that seemed confusing to me
Rainsmom, on the call I think they said they were waiting for the full results to try and understand the inconsistency that you pointed out. trw144, you are spot on. We certainly can't make accurate comparisons at this stage, all we can take from this is that the results are promising enough to move forward. We are all essentially speculationg at this point in time.
Rainsmom, on the call I think they said they were waiting for the full results to try and understand the inconsistency that you pointed out. trw144, you are spot on. We certainly can't make accurate comparisons at this stage, all we can take from this is that the results are promising enough to move forward. We are all essentially speculationg at this point in time.
saveferris2009
New member
Interesting perspective:
<b>Vertex falls after analyst expresses doubt about cystic fibrosis drug </b>
Vertex (VRTX) is retreating after Cowen's analyst Dr. Phil Nadeau said he's not convinced that the company's VX-809+Kalydeco treatment for certain cystic fibrosis patients will be successful. The analyst believes that the improved interim lung function data from the Phase II trial of the treatment may not be duplicated in longer Phase III trials. Dr. Nadeau, - who believes that most investors now expect the treatment to be successfully developed - identifies two main reasons for his skepticism. First, each patient's interim lung function, or FEVI, can change without indicating a true change in lung function, he said. Dr. Nadeau is concerned that the study didn't adequately account for this factor. Secondly, the study didn't record a significant sweat chloride change in the patients, even though the treatment is supposed to work by improving CFTR function, which is correlated with sweat chloride, Dr. Nadeu contends. In mid-morning trading, Vertex declined 95c, or 1.49%, to $62.99. :theflyonthewall.com"
http://www.theflyonthewall.com/permalinks/entry.php/VRTXid1641918/VRTX-Vertex-falls-after-analyst-expresses-doubt-about-cystic-fibrosis-drug
<b>Vertex falls after analyst expresses doubt about cystic fibrosis drug </b>
Vertex (VRTX) is retreating after Cowen's analyst Dr. Phil Nadeau said he's not convinced that the company's VX-809+Kalydeco treatment for certain cystic fibrosis patients will be successful. The analyst believes that the improved interim lung function data from the Phase II trial of the treatment may not be duplicated in longer Phase III trials. Dr. Nadeau, - who believes that most investors now expect the treatment to be successfully developed - identifies two main reasons for his skepticism. First, each patient's interim lung function, or FEVI, can change without indicating a true change in lung function, he said. Dr. Nadeau is concerned that the study didn't adequately account for this factor. Secondly, the study didn't record a significant sweat chloride change in the patients, even though the treatment is supposed to work by improving CFTR function, which is correlated with sweat chloride, Dr. Nadeu contends. In mid-morning trading, Vertex declined 95c, or 1.49%, to $62.99. :theflyonthewall.com"
http://www.theflyonthewall.com/permalinks/entry.php/VRTXid1641918/VRTX-Vertex-falls-after-analyst-expresses-doubt-about-cystic-fibrosis-drug
saveferris2009
New member
Interesting perspective:
<b>Vertex falls after analyst expresses doubt about cystic fibrosis drug </b>
Vertex (VRTX) is retreating after Cowen's analyst Dr. Phil Nadeau said he's not convinced that the company's VX-809+Kalydeco treatment for certain cystic fibrosis patients will be successful. The analyst believes that the improved interim lung function data from the Phase II trial of the treatment may not be duplicated in longer Phase III trials. Dr. Nadeau, - who believes that most investors now expect the treatment to be successfully developed - identifies two main reasons for his skepticism. First, each patient's interim lung function, or FEVI, can change without indicating a true change in lung function, he said. Dr. Nadeau is concerned that the study didn't adequately account for this factor. Secondly, the study didn't record a significant sweat chloride change in the patients, even though the treatment is supposed to work by improving CFTR function, which is correlated with sweat chloride, Dr. Nadeu contends. In mid-morning trading, Vertex declined 95c, or 1.49%, to $62.99. :theflyonthewall.com"
http://www.theflyonthewall.com/permalinks/entry.php/VRTXid1641918/VRTX-Vertex-falls-after-analyst-expresses-doubt-about-cystic-fibrosis-drug
<b>Vertex falls after analyst expresses doubt about cystic fibrosis drug </b>
Vertex (VRTX) is retreating after Cowen's analyst Dr. Phil Nadeau said he's not convinced that the company's VX-809+Kalydeco treatment for certain cystic fibrosis patients will be successful. The analyst believes that the improved interim lung function data from the Phase II trial of the treatment may not be duplicated in longer Phase III trials. Dr. Nadeau, - who believes that most investors now expect the treatment to be successfully developed - identifies two main reasons for his skepticism. First, each patient's interim lung function, or FEVI, can change without indicating a true change in lung function, he said. Dr. Nadeau is concerned that the study didn't adequately account for this factor. Secondly, the study didn't record a significant sweat chloride change in the patients, even though the treatment is supposed to work by improving CFTR function, which is correlated with sweat chloride, Dr. Nadeu contends. In mid-morning trading, Vertex declined 95c, or 1.49%, to $62.99. :theflyonthewall.com"
http://www.theflyonthewall.com/permalinks/entry.php/VRTXid1641918/VRTX-Vertex-falls-after-analyst-expresses-doubt-about-cystic-fibrosis-drug
Vertex has released some corrected results from the trial, with the results not quite as good as previously thought. <a title="http://investors.vrtx.com/releasedetail.cfm?ReleaseID=677520 " href="http://investors.vrtx.com/releasedetail.cfm?ReleaseID=677520%20">http://investors.vrtx.com/releasedetail.cfm?ReleaseID=677520 </a> Vertex is down 20% premarket. - Corrected Data: Responder analysis showed 35% of patients experienced an absolute improvement in lung function (FEV1) of at least 5 percentage points and 19% had at least a 10 percentage-point improvement when treated with VX-809 and KALYDECO - - Additional Data: Patients treated with VX-809 and KALYDECO experienced an 8.5 percentage point mean absolute improvement in lung function compared to patients treated with placebo (p=0.002) - - Vertex plans to start a pivotal study of this combination to treat the underlying cause of CF in adults with two copies of the F508del mutation, pending final data and discussions with regulatory agencies -
saveferris2009
New member
@James, similar to what I posted on 5/25 above!