Phase 3 950

Hey guys, Anybody got any idea what the upcoming Phase 3 will look like? Arms? Control arm? Any info or informed guesses? jm

[VXman]

The only thing that appears certain is that the trial will be specifically for treatment naive patients. This information was confirmed in the recent Vertex financial press release.

[dancegirl54]

When will Phase 3 start?

[VXman]

Although Vertex has announced that it expects to receive approval and will initiate the Phase 3 trial during 4th quarter 2007, it really means that enrollment will begin in the 1st quarter of 2008. Actual dosing would likely occur at the beginning of the 2nd quarter of 2008. You can bet that the vast majority of clinics that were awarded the Prove 3 trial (IIb), will also be campaigning to manage the Phase 3 trial. The Prove 3 supported approximately 440 patients. The Phase 3 will be well above 1,000 patients. I remember this time last year as I was anxiously waiting for the Prove 3 trial to be initiated. It was scheduled for the 4th quarter of 2006. I started dosing on May 2, 2007. Just remember for your piece of mind, there is a significant difference in the calendar dates for: trial initiation, enrollment, screening and dosing.

[copyman]

is there anyway to find out what were the locations of the Prove 3 trial sites ?  specifically NJ or Philadelphia area. when will the Phase 3 recruiting sites be up on the clinical.gov site? thanks

[Forseegood]

thanks for the wealth of info youre providing us...

[VXman]

Copyman - here's the direct link to the government "Clinical Trials" website. There was one in Hershey and Pittsburgh. Because the enrollments are closed, the government pulls back on a lot of the specific information such as telephone contacts. A little further research by yourself to the large Medical Research/Teaching Universities may reveal the specific info you are looking for. The "early bird catches the worm" is so true. Follow-up and get yourself on their lists!

http://www.clinicaltrials.gov/ct/show/NCT00420784?order=3

Forseegood - thank you for your kind comment. The pleasure of sharing information is all mine!

[Forseegood]

HI, I was looking around (I'm very tired and it's hot, so maybe my investigative powers aren't the best:) and I'm trying to find where it says that it will only be recruiting treatment naive patients, thanks so much, really appreciate this!

[Andiamo1]

The Vertex CEO said, at a news conference, that the phase 3 trial would first include only naive patients.  Someone posted a link to this conference and I forgot where it was.  I think you can find it on the Vertex website.

You should visit Maine this time of year.  It is cool and beautiful here.  Almost as much fun as sailing!!  I hope you feel better soon.

As awful as I was feeling, this trip to Maine has calmed me down and I feel much better.

[orleans]

Anyone know if there were any Prove 3 clinics in Atlanta or Birmingham Al. ?? thanks, jm

[VXman]

Atlanta and Birmingham were both included in the PROVE 3 Trial.  Take a look at the link I provided above (and below) and scroll down to the trial locations.

http://www.clinicaltrials.gov/ct/show/NCT00420784?order=3

[Forseegood]

oh, I've been following your sailing exploits!...in that regard, I'm sure you realize how lucky you and your wife are! Having just got in from exercising my dog at the park in the blistering heat (I almost asked her to drive home) I can only hope that someday I'll be able to come visit Maine, a nice cool place to sail right now sounds heavenly...thanks for the Vertex tip, I just get lazy sometimes and ask too many questions, when I should be looking things up myself:)

[VXman]

This is text from the Form 10-Q (Quarterly Report) for Vertex, which I couldn't find through any links within the Vertex website: however, it was easily found in the financial links within Yahoo. Here are the paragraghs and lead-in to the disclosure that the Phase 3 Trial is being tailored around treatment naive patients.


"Clinical Development Programs

We continue to conduct clinical trials of our lead drug candidates. Our development of telaprevir illustrates our focus on maintaining greater development control of our drug candidates. We are conducting three major Phase 2b clinical trials of telaprevir in genotype 1 HCV patients. PROVE 1 is ongoing in the United States and PROVE 2 is ongoing in the European Union, both in treatment-naïve patients. PROVE 3 is ongoing with patients in North America and the European Union who did not achieve a sustained viral response with previous interferon-based treatments. We have completed enrollment of patients in all three of the PROVE clinical trials, bringing the total number of patients enrolled in the PROVE clinical trials to over 1,000. More than 350 patients have completed 12 weeks of telaprevir-based dosing. We also anticipate that we will initiate in 2007 a clinical trial exploring the potential of twice-daily dosing of telaprevir in combination with pegylated interferon, or peg-IFN, and ribavirin, or RBV.



--------------------------------------------------------------------------------

We have scheduled a meeting with the United States Food and Drug Administration to evaluate interim data from the PROVE 1 and PROVE 2 clinical trials. Depending on additional data from the PROVE program and the outcome of discussions with regulatory agencies, our objective is to initiate an international Phase 3 clinical trial for telaprevir in genotype 1 treatment-naïve patients in the fourth quarter of 2007. The registration strategy and the timing of a New Drug Application, or NDA, will be dependent on data from our clinical trials and discussions with regulatory authorities. Designing and coordinating large-scale clinical trials to determine the efficacy and safety of telaprevir and to support the submission of an NDA requires significant financial resources, along with extensive technical and regulatory expertise and infrastructure."

http://biz.yahoo.com/e/070809/vrtx10-q.html

[Forseegood]

thanks! much obliged!

[orleans]

what's this about double dosing? I haven't heard this before. What prove would that be?  Seems like they would  forget about cutting out the riba(to bad)    RBV? jerry m  

[DCbobo]

Seems like you hae a lot of good information about VX950.  I've been keeping an eye on the news for months now, waiting for Vertex to issue the next test results for the clinical trial NCT00420784.  I see that Seattle is on the current trial list but, don't know where in Seattle.  My gastro doctor hasn't been any help.  Does anyone know how I would find out?  Thanks for any help you can give me to investigate this.  ***@****

[purplecat]

I heard CPMC San Francisco did get the Phase 3 Naive trial coming up.  They did the Naive Prove 1 that I'm in now and final 6 Month post PCR's  will be completed  Feb.2008. CPMC SF did NOT get the Prove 3 nonresponder trial still ongoing.

My trial NP told me Vertex was trying to evenly distribute trial management contracts as fairly as possible to qualifying Trial Center applicants.

Just like trial participants, qualifying hospitals and Hepatology Centers must apply and be picked to manage a trial.  There is always more applicants then trial slots available.