The Ph.2 results were shared 10/09 I believe. This is exciting though! I just didn't want you to think no one had any idea about the results until now. The journal articles always take a lot longer to process all the details of the trial.
Here's my personal connection since you asked if anyone has participated. I enrolled in Ph.II (Part 2B - the trial where 1/3 each received placebo/150 mg or 250 mg.) in July 2008 and was on 150 mg for 28 days (they unblinded me afterwards). Although Ph.2 trial participation did not include a non-disclosure request, Ph. 3 did. For this reason I am not going to go into details out of respect of the fact that this trial is still going on and also because I am still taking V770 and data is still being collected on me. I participated in Ph. 3 from 10/09-10/10 and now have been switched to open label hopefully through when it will go to market.
For me looking at the NEJM article meant that I learned that by day three the patients had established the new level of chloride channel function. I've never seen the details of what my sweat test was after taking V770 but was always curious...especially for the overall results. It looks like we all entered at around the 95-105 point and we all.....yes!!---- I have this correct dropped to 40-60 sweat chloride results. Well those on 150 mgs did. Strangely (to me at least) the 250mg dosers actually didn't go as low. The dosing going forward is set for 150mg as has been announced.
The magnitude by which the npd and the lung function changed was not on the same level. The journal reminds us though that this study was only 28 days with a small number of participants. Also not mentioned but I think worth mentioning are that the people that this is being tested on have MANY years of cystic fibrosis hindering their lungs ability to just pop right back into a healthy state. While I hope my lungs get all better, I realize more realistically I'll have some lasting lung damage :-( SO MOMS & DADS READING THIS - DO YOUR PT ON YOUR KID EVEN IF THEY HATE IT BECAUSE THIS WILL COMBATE POSSIBLE PERMANENT DAMAGE FROM SETTING IN!!
The results will only get better I'm confident especially as it is tested (and later adopted by) our younger generation of cfers in our younger community and it helps to stave off the crippling effects of this disease. While we in the cf community are so attuned at looking at the "Cf symptom" that a cf drug treats. This is not a cf symptom drug. It treats the root of the problem. So while we might like to think of comparing it to this or that drug in terms of how it lines up with regards to lung function effects I believe this is shortsighted.
With that all said, the mean change in FEV1 was 0.25L. If you wonder what sort of a gain that means for you take your FEV1 Liter number (not %) and add 0.25 to it. Let's call that your "new possible." Multiply your FEV1 Liter number by 100 and divide by your "new possible." Minus that from 100 and you get your percent of change.
I didn't look to see if they announced any statistical info BMI changing with use of it but that would be interesting to note to as I do not think before this journal it has publically been announced.
