What is going on with Vertex?

[rosesixtyfive]

Okay, now that I just realized we are close to finding out what is going on with phase 3 for ddf508, I just can't wait. I heard some negative news, has anyone heard anything positive? I don't think I can wait until July.

rosesixtyfive, mother of Sam, ddf508, 4 years old

 

[nmw0615]

From speaking with one of my doctors, she believes the better drug combo will be Kalydeco and vx-661, not vx-809. VX-661 is currently in phase two. At the time, I wasn't able to question her more on why she feels this way, but I'm interesting in asking her more next time I see her.

 

[grammakaky]

Our doctor said the same thing. His hopes are in the vx-661 and he told us that a year ago. I just hope the vx-661 doesn't get a delay if the vx-809 isn't promising.

 

[Rosie55]

Vertex posted positive results this morning! I read it on thestreet.com but I think you can google it and find information on several sites now. Their stock is currently up and I think they are even more optimistic about the next drug, VX 661. As long as they have successes and make money they should keep pushing forward with their research and drug development. The results were not as exciting as Kalydeco was for g551d but showed a 30% reduction in exacerbations and anyone with CF would take those results!

 

[occupyjapan]

The trials were a complete success and Lumacaftor met all its endpoints. It will be to market in 2015. I have a friend who is on the combination of Lumacaftor and Kalydeco. Despite the numbers quoted by Vertex (those ARE just averages, afterall), he experienced a ~10% increase in lung function, put on 10 lbs after only a couple weeks, and his quality of life is VASTLY improved according to him. He also sporadically cultured PA and hasn't anymore since being on the combo.

 

[chelsie882003]

Okay, now that I just realized we are close to finding out what is going on with phase 3 for ddf508, I just can't wait. I heard some negative news, has anyone heard anything positive? I don't think I can wait until July.

rosesixtyfive, mother of Sam, ddf508, 4 years old

If you go to www.cff.org and look at the drug pipeline. it tells you the results. the results say for whoever has double DF508

Results from two Phase 3 trials in people with CF who have two copies of the F508del CFTR mutation showed significant improvement in lung function and other key measures of the disease. Based on these results Vertex plans to submit a New Drug Application (NDA) by the end of 2014 to the Food and Drug Administration (FDA) for review with possible approval in 2015.