To Coeric: Question on Phase 3 VX at UCHSC

[FrontRangeMom]

I'd like more information on what Dr. Everson said about recruiting for VX-950 Phase 3.  I recently saw Dr. Forman who referred me to the clinical trials coordinators.  They said that the Prove 3 trial was full at their site, and had nothing else open I was eligible for.  So, I'm probably going to go with Pegasys maintenance therapy, although the clinical trials rep said that would make me ineligible for other trials that come up.  No one mentioned a Phase 3 for VX coming soon.  Do you know someone I could contact at CU about the Phase 3?  I'm surprised that it would be coming so soon since they are still running the Phase 2b Prove 3 trial and usually a Phase 3 trial isn't initiated before the Phase 2 data are analyzed.

Thanks for any info that you have.

[coeric]

I had an initial consultation with Dr. E on 4/2.   He spoke of the clinical trials that he had, and stated that he would be recruiting for a phase 3 VX-950 trial in the fall.  From the investor's meeting at the Barcelona liver conference we learned that vertex, and the investigators were planning on meeting this summer with the regulatory agencies to discuss the study plans for phase 3.  

on 4/14 during the investors meeting a table was presented that shows phase 3 clinical trials starting in December. it is slide number 11 in the following link.
http://investor.shareholder.com/vrtx/eventdetail.cfm?EventID=36774

Since there is no study plan yet, the trial coordinator is not going to be in a position to discuss the trial.  so we don't know who will be excluded from the trial. my guess is that the actual trial will start in the winter.  hope this helps.

eric

[FrontRangeMom]

Thanks for the input.  I was a bit suspicious of the "not eligible for other trials" comment as well. I'll check out the slides and keep my eyes and ears open.

"Mom"

[coeric]

i could be wrong about this and perhaps someone who knows more than i will chime in - the trials that take the non-reponders specify that you be off interferon for a period of time before starting the trial. perhaps this would include maintenance therapy too.  anyway if you do decide to do the maintenance the folks at UC have lots of experience from the HaltC trials.  

e