Red, so glad your dd will be on trial...was watching to hear that! Re the delay...I think the delay was because vertex was negotiating parameters with FDA so long and kept details secret from centers until announced publicly. Heard lots of centers had thought they'd know and be able to start first march then April then may, but couldnt do anything because didnt know parameters so they didnt have any leg work done. The delay is worth it though because six months, higher dosing, and adult and peds all at same time. Now it is just each center getting up and running that takes time. Vertex said last conference that that was only centers getting up and running that is delay. Don't think pulmozyme is an issue at all...everyone is on that in general. Antibiotics not really a concern either...just have anyone on start at specific date if they want consistency but since no mono dosing and six months, no matter when they start that affect will be known. And as q said three cites currently recruiting or four I guess, with many more soon. July vertex will tell status. I don't think any issue with recruiting...I speak with probably twenty cf families and all are banging down doors to get in and are calling centers to get it. Ds is too young, but can't wait for this to be to us by 2014! Godspeed Red and redette
Both 'transport' and 'traffic' K+809 Phase 3 studies started enrollment.. Check clinicaltrial.gov and type in VX 809 in the search bar and you can monitor the initiation of the enrollment progress at the various sites as they start dosing patients.
Win and Q, it has been a year since the first full data from Ph II were released (though there was a mixup). The reason it is taking so long to start Ph III must be related to the complexity of the trial design that can satisfy the FDA. The FDA must be demanding, as it should, that Ph III trial should isolate the effects of antibiotics and of pulmozyme from the effect of the drug combo. It is complex because different participants take different antibiotics and some don't take at all. You would need many arms and subarms to control the objectivity of the trial outcome. Besides, they don't take the antibiotics at all times; there are on/off cycles. One could alternate a 4 week antibiotics “ON” cycle and another 4 week “OFF” cycle during the 24 week trial for participants who need to take, and require all to synchronize the first antibiotics off cycle to the initiation of 809+770 dosing for each type of antibiotics. Hopefully this scheme could isolate the effect of antibiotics from the effect of study drugs. Q, what do you think? Am I talking nonsense?