VX950 response

I just got a response to an email inquiry I made 1 month ago.  I'm not sure what calander they are on, but there isn't much left in this year on mine, so I wonder how much later is late in the year for the trial sites to be updated with the information they indicate?

Vertex response:

"Thank you for writing us.  Vertex has one clinical trial with VX- 950 for treatment naive patients which is enrolling patients in Europe.  The next  VX-950 trial, which will be for non-responders, is scheduled to start late this year.  For enrollment into any clinical trial , you will need to be assessed at a clinical trial site.   Please see www.clinicaltrials.gov to view specific trial sites for clinical trials of VX- 950."    

[GrandOak]

Also, if I go to the indicated site and search for VX950, all I get is the following which indicates study is beginning in August of 2006:

Phase 2 Study of VX-950, Pegasys

[amommy]

I just laughed out loud when I read your post.  I wonder if they are operating on the fiscal calendar, considering that is their top priority?!!? :)

[FlGuy]

If you are interested in the next phases, you might need to do a little more sleuthing. It's looks like Phase 2 was done in 'Rochester' and I assume that means Mayo in your area. What you could do is go to the Mayo website and see if you can track down a number for the hepatology clinic.  Then, start making calls to see if you can locate the trial 'manager' or 'coordinator' at Mayo for the Vx trails.  If you are able to get someone who has a clue, give them a brief rehearsed re-cap of your current situation.  Maybe follow up with a letter or an email.  I've been told by such a 'coodinator' that for them to remember you and recall your situation, a potential participant needs to make himself know without being too much of a pain in the butt. And, maybe have your doc intervene.  Keep in mind that many trials require that pts who have had ifn/riba tx before be 6 months removed from the treatment.

[Kalio1]

You also might want to try to findout if there is a "wash out" period before they will accept you into the trial. Washout periods are usually 6 months at least. That means they don't want you to have been on IFN for the previous 6 months so that the IFN has had a chance to "washout" of your system before starting the trial.

[GrandOak]

What's scarier is the response was from development staff, which makes me hope that those actually conducting the trials are a bit more in touch with the real world and living in the here and now time.

[GrandOak]

I understand about the off tx period for trial enrollment, which is why I'm trying to find out where I can obtain more information on their enrollment criteria.

[couldn't think of a nickname]

They are scheduled to do a web cast at 2:50 eastern, they may talk about it more then. They did say the other day that the trials would start by the end of this year, but remember, that doesn't mean dosing. They need to do a lot of things that others on here could describe in better detail as far as prescreening and recruiting, before they dose.

But, the web call might just be a dog and pony show for institutions. It still pays to listen as there are some analysts that ask good questions, and some information can sometimes be gleaned.

[APKhaos]

Its definitely an investor community sales presentation, and most of what has been said so far is well known to folks on this board.

[APKhaos]

Oops....

There was some clarification on the trial schedule. The US trial for non-responders will begin in 4Q06.

Begin means submission of the proposed protocol, peer review, preparation of final protocol/Consents form, and approval by FDA. All this takes a while. The Prove 1 trial was going to 'start' in March 06 when I first registered as a potential subject in November 05. The preparation/approval phases forced the actual first dose date out to 15 June 06. This was my start date, which was among the first in the cohort.

That said, my guess at subject screening is sometime early 2007, with the first dosing for the non-responder trial sometime around third quarter 2007. However, the earlier you identify, contact, and 'become known' to your local trial site, the better. Its entirely possible that the trial sites are not finalized yet, and the selection & exclusion criteria are not yet prepared. As has been said above, some minimum time since completion of last SOC dosing seems to make sense. There will be lots of other criteria.  Still, its time to get on the eager beaver list. They like eager beavers, who are more likely to comply with the trial requirements and more likely to go the distance.

This should be really encouraging for non-responders, especially if the Prove 1 results are decent.

[GrandOak]

Thanks for info.  I've tried to connect but was unable because it said the stream was unavailable or being limited in allowed connections.

[APKhaos]

GO said: "What's scarier is the response was from development staff, ....."

You seriously expected schedule information on stuff outside the lab from development staff?? Many developers are barely aware of what day it is! :-)

They are very low on the list of staff who might have a detailed clue about trial schedules.

[willows]

My doctor sent me a letter a month ago and shared with me that the U of Washington clinic I go to was going to apply to become a site for the next trial.  He wants me in it if this is possible, I am geno one, non-responder.  My question to you is, does the study pay for the drugs or does our insurance?  I have United Healthcare, which I have read here is very reluctant to pay for a second try with Peg and Riba.  So I'm wondering, will they pay for the trial, since it is "technically" just another try, but has VX950 added to the regimen?  Can you help me?

Thanks!!!  I'm excited about the prospect of trying VX, but waaaaay not excited about IFN and riba again.

Willow

[couldn't think of a nickname]

You are on their dime. In the prior trials, they even paid for the the treatment after the trial, so those who wished, could go for SVR.

[APKhaos]

ALL trial drugs are provided, VX + Peg + Riba [assuming VX + SOC].

Additional drugs for sides, such as sleepers, ADs, Procrit, Neupogen etc are out of pocket. Your insurance may cover some/all of these, but you are likely to have some more than minimal copay. I think Procrit is something like $2,000/month, but its the highest by far.

You are doing the right thing by getting on the potential subject list with a local trial site, and doing it now. You'll find someone at the site who will keep you posted as things progress.

I can't imaging how tough it must be to step up to a second or third round of tx, but at least it should be shorted duration in the trial.

[susan400]

My next step will probably be in one of these type of trials.  I've made the initial contact with the Mayo Clinic in Jacksonville, FL.  They told me the wait for me would be approx., 6 mon. to 1 year.  Since I am a non-responder and not a naive patient.  I don't know if I would fit the other criteria.  My doctor seems to think that I would.  He says my age, weight, non-cirrhotic status and no major other illness issues would make me a good candidate. My 6 mon. post treatment wash-out phase will be completed by the Christmas time frame.  Their 6 mon. to 1 year time frame that they listed would be anywhere from June 1 to Dec. 1 of 2007.  Does that sound about right?  Who knows at this point.  God does.  I don't  I sure hope that the treatment study does pay for all these drugs.  The way that UHC has been dragging their feet lately on ANY drug that I try to get from them makes me think that they will probably not pay a dime for any regular treatment I may try to get.  I still have available lifetime, so that's not the issue here.  I had been trying for the past 5 mon. to get them to pay for the Ambien and when they finally agreed to cover it thru their mail-order, I was shocked to find out that my portion was going to be $250 for a 90 day supply.  My normal co-pays are this high! So, I called the UHC 1-800 number and questioned that.  They've labeled Ambien as a Tier 4 drug, which means they don't want to pay squat!   Oh well.  I can't do anything about it, so....
Susan

[willows]

Thanks guys!!  I got all involved making reindeers and forgot to check for your answers.  One more step in the right direction.  Man, do I hope the U of W gets approved, my doc will be the head of the program and he is very cool.  First time I tried tx, my doc was gastro and was fairly ignorant.  Most of us here are waaaay smarter than he was.  Hep C can do that to a person, seeking information because there just isn't much out there easily accessible.  Someday, we will all be considered warriors, fighting this good fight and without a lot of support from the medical or insurance establishment.  Mostly, I'll just be glad when folks don't think I'm a drug user or a drinker.  Just a gramma.  Making reindeers for Christmas.  Wish I could post a picture, they are pretty cool reindeers!  Thanks again for the help.
Willow