VX-661 Phase 2 Study

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natureimpulse

Guest
"Combination Study in Most Common Type of CF: Vertex is also conducting a Phase 2 study of the CFTR corrector VX-809 dosed in combination with KALYDECO in people with the most common CFTR mutation, known as F508del. Final data from this study are expected in mid-2012. The study enrolled people with two copies of the F508del mutation (homozygotes) and also included the first evaluation of KALYDECO combined with VX-809 in people<span style="background-color: #ffff00;"><span style="background-color: #ffffff;"> with one copy of the F508del mutation and one copy of certain non-gating mutations (heterozygotes). A Phase 2 study of VX-661, a second CFTR corrector, dosed in combination with KALYDECO is also ongoing, with data expected in the second half of 2012. !"
What's mean 'and one copy of certain non-gating mutations (heterozygotes)'?
That's all mutation different than f508del or some particurally?
 
N

natureimpulse

Guest
"Combination Study in Most Common Type of CF: Vertex is also conducting a Phase 2 study of the CFTR corrector VX-809 dosed in combination with KALYDECO in people with the most common CFTR mutation, known as F508del. Final data from this study are expected in mid-2012. The study enrolled people with two copies of the F508del mutation (homozygotes) and also included the first evaluation of KALYDECO combined with VX-809 in people<span style="background-color: #ffff00;"><span style="background-color: #ffffff;"> with one copy of the F508del mutation and one copy of certain non-gating mutations (heterozygotes). A Phase 2 study of VX-661, a second CFTR corrector, dosed in combination with KALYDECO is also ongoing, with data expected in the second half of 2012. !"
What's mean 'and one copy of certain non-gating mutations (heterozygotes)'?
That's all mutation different than f508del or some particurally?
 
S

semperfiohana

Guest
they are already recruiting for vx-661 phase II. you can look it up on the clinical trials website and it will give you the locations.
 
S

semperfiohana

Guest
they are already recruiting for vx-661 phase II. you can look it up on the clinical trials website and it will give you the locations.
 
N

natureimpulse

Guest
What's mean 'and one copy of certain non-gating mutations (heterozygotes)'?

That's all mutation different than f508del or some particurally?
 
N

natureimpulse

Guest
What's mean 'and one copy of certain non-gating mutations (heterozygotes)'?

That's all mutation different than f508del or some particurally?
 
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semperfiohana

Guest
these are the most common gating mutations according to wiki
?F508
G542X
G551D
N1303K
W1282X
don't know if that helps at all. i know you are looking for what non-gating mutations are
 
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semperfiohana

Guest
these are the most common gating mutations according to wiki
?F508
G542X
G551D
N1303K
W1282X
don't know if that helps at all. i know you are looking for what non-gating mutations are
 
S

semperfiohana

Guest
here is the criteria for vx-661 per the clinical trial website
Criteria

Inclusion Criteria:

Male or female with confirmed diagnosis of CF
Must have the F508del-CFTR gene mutation in both alleles.
FEV1 40% to 90% (inclusive) of predicted normal for age, gender, and height (Knudson standards)
Subjects of child-bearing and who are sexually active potential must meet the contraception requirements.
 
S

semperfiohana

Guest
here is the criteria for vx-661 per the clinical trial website
Criteria

Inclusion Criteria:

Male or female with confirmed diagnosis of CF
Must have the F508del-CFTR gene mutation in both alleles.
FEV1 40% to 90% (inclusive) of predicted normal for age, gender, and height (Knudson standards)
Subjects of child-bearing and who are sexually active potential must meet the contraception requirements.
 
A

amber682

New member
I *think* it means it also tested people with one deltaf508 mutation and one other mutation that is neither DF508 or a gating mutation (which Kalydeco works for)
 
A

amber682

New member
I *think* it means it also tested people with one deltaf508 mutation and one other mutation that is neither DF508 or a gating mutation (which Kalydeco works for)
 
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mdej

New member
It means that that you may participate if your mutation isn't a gating mutation. They want participants that wouldn't benefit from VX 770 (Kalydeco) alone. Suppose I had G551D and F508Del. I'd benefit regardless of whether or not VX 809 works because Kalydeco works on G551D. They're just trying to prevent false positive results.
 
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mdej

New member
It means that that you may participate if your mutation isn't a gating mutation. They want participants that wouldn't benefit from VX 770 (Kalydeco) alone. Suppose I had G551D and F508Del. I'd benefit regardless of whether or not VX 809 works because Kalydeco works on G551D. They're just trying to prevent false positive results.
 
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MargaritaChic

New member
semperfiohana, the list you posted are the most common mutations. <strong>Not</strong> the most common <strong>gating</strong> mutations.
Does anyone have a list of what mutations are gating mutations?
 
M

MargaritaChic

New member
semperfiohana, the list you posted are the most common mutations. <strong>Not</strong> the most common <strong>gating</strong> mutations.
Does anyone have a list of what mutations are gating mutations?
 
D

DrRoe

Guest
G551D, G178R, G551S, G1349D, S1255P, G1244E, G970R, S549N, S549R, S1251N

http://www.sefq.es/ECFSPacientestratablesconVertex770.pdf
 
D

DrRoe

Guest
G551D, G178R, G551S, G1349D, S1255P, G1244E, G970R, S549N, S549R, S1251N

http://www.sefq.es/ECFSPacientestratablesconVertex770.pdf
 
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