Mid to Late Dec-07 FDA on Phase III

[somuchmore]

Much news back during Boston Conference suggested FDA and Vertex where working toward defining next guidelines for Phase III of VX-950. Then not much since then. It is December 10th and I assume the FDA will go into a holiday period in a few weeks.

Is there any expectation of news about FDA guidelines and Phase III of VX-950?

Or, did I miss something/misunderstood?

Thanks,

[mremeet]

I was in the prove 1 VX950 trial and have been following its development fairly closely for over a year now. Firstly, phase 3 testing is coming, probably pretty soon (within 3 months I'd say). Secondly, although the drug have some pretty gnarly side effects, it works in very significantly enhancing odds of achieving SVR in the vast majority who take it with IFN and riba.

As far as how the trial will be structured, I imagine it will be structured relatively conservatively compared to some of the previous Prove groups. My guess is that first, there will be no groups without ribavirin, second there will be no 12 week groups, third there will be no placebo/control groups. I would imagine treatment will last at least 24 weeks and there will be a sliding/adjustable treatment duration based on initial antiviral response, time to UND, and INF/riba/TVR dose adherence. For instance someone in a 24 week group who displayed a rather lacklustre time to UND (say it took them 8 weeks to go UND, as opposed to the usual 1-3 weeks), then their "sentence" of treatment might be commuted to 48 weeks etc. I don't know if rescue drugs will be allowed, but from what I've read phase 3 trials tend to be more flexible than the earlier phase trials (and rescue drugs were allowed after TVR was concluded in both prove 1 and 2).

Overall if you wanted to get into a telaprevir trial, the final phase 3 trial should offer you substantially superior odds of being cured when compared to any of the phase 1 or 2 testing conducted to date.

[somuchmore]

Yes.

As uou stated.
"expectation that Phase III trials would be underway by now"

This is my question. I realize my liver may not qualify for the Phase III trial but thinking that Phase III progress could lead to treatment for all by '09/'10.

I am just trying to stay as heathly as possible until a treatment is approved for the mass population of non-responders. I was treated in '97 and again in '02 but non-responder for both inter/riba & then peg/riba as well.

Just hoping for success to develop for all, sooner than later.

[JRenquist]

Check out the Yahoo message board for VRTX. They are being pretty pessimistic, because everyone thought that there would be some news by now. There was the expectation that it would be approved before the end of 2009, but there was also the expectation that Phase III trials would be underway by now. Not a case of "no news is good  news"  I'm going to try to get in the Phase III trial if there is no arm without ribavirin. Good luck.  S.

[Proactive]

I don't know where your liver damage stands (you mentioned transplant). I do know the vertex/J&J phase 2a trials in Europe appear to be excluding those with liver cirrhosis or decompensated liver disease, and including only treatment the naive

"Exclusion Criteria:

No contra-indications for starting anti-HCV therapy
No history or evidence of liver cirrhosis or decompensated liver disease
No other cause of significant liver disease in addition to Hepatitis C
Not infected with HIV or Hepatitis B
Not pregnant, planning to be pregnant or breastfeeding or not the partner of a woman who is pregnant or breastfeeding "
http://www.clinicaltrials.gov/ct/show/NCT00528528?order=1

[somuchmore]

Thanks for the information.

But, I'm looking out for information about a cure for my HCV before transplant becomes the only choice I have. Another ticker would appear to be about stock buying which I have little interest in at this point. Trial news from Heptimax, Vertex, SCH, or others is good to know. However, I see Phase III of VX-950 the next step toward getting to take a possible cure without needed to be a trial.  Again a cure is my hope.

[Proactive]

Quest Diagnostics trades under the symbol DGX..................

[Proactive]

Don't know much about vertex's and the fda regarding phase 3 protocol, but it appears phase 2 trials are still underway..
What I do know is that the Heptimax test is performed by Quest Diagnostics