Cohort 3 has been started on 08/23/2012 and 80 subjects will be recruited.
VX 809 will be given bid or tid doses ( instead of qday and I believe 400 mg dose) from day 1--> 28 and then Combo of VX 809 and 770 bid or tid from day 29 --> 56. It seems VX 770 will be used tid ( instead of bid before) as well in some subjects.
The estimated completion date is April 2013; using recent history as a guide, we'll be lucky to see this data within a year. Looking at the way this stock trades, Vertex is in desperate need to show some progress with the pipeline immediately.
Okay, found the info from clinicaltrials.gov. Some thoughts and please let me know if you agree/disagree, etc.
I think the Cohort 3 details indicates some very promising news. 1) They are doing higher doses and that they are enrolling up o 80 subjects, shows they are serious that these higher doses will work. (Remember the other arms had the 100 subjects broken into heter/homo and 3 different doses for heter. 2) Looks like Vertex is increasing both VX770 and VX809 because VX770 was dosed 2x a day and is now 2x and 3x. And VX 809 was dosed 1x a day and now 2x or 3x. 3) Finally, and this is where I could really use some other insights. If VX809 was only dosed 1x a day for cohort 1 and 2 and they are doing both 2x and 3x a day at higher doses, could that mean that the wash out rate is pretty quick, i.e., 8 hours? And if that is so, could it mean that the 1x a day of 600 if washed out in 8 hours could be dosed 600 3x a day??? Vertex didn't think it had reached the plateau for dosing yet, i.e. could get even better results with higher dosing. And said it had lots of room to move for higher dosing. Can Pk tell the wash out like that? If it is washed out in 8 hours, could they then do 600 3x a day? Obviously they are going higher and that by itself will be good news I think, but the fact that Vertex is doing 3x a day I think says something about washout???
Excellent finding and observations by both Rojospan and Verity.
The new trial is testing higher daily doses for VX-809. If I guess, a group is dosed bid (400mg each) for a total 800mg per day, and the other group is dosed again 400mg tid for a total daily dose of 1200mg. The reason they use the bid and tid dosing is to protect the trial participant from possible adverse effects (of exposure surge if dosed qd), I think.