Aa
Infergen and VX-950 Trial Warning
Spoke to Cedars-Sinai hosp. in L.A. yesterday where they are holding the VX-950 trials for non-responders. Just wanted to pass on what they told me to everyone who is interested in entering that trial. If you have been on Infergen, you will be excluded from the trial for some unknown reason.
This is the case with me, as my last failed treatment was with Riba and Infergen. They are going to try and get a waiver so I can enter the trial. Just a warning to all that it is their current policy. Again, no explanation why. Talk to your doctor if you are anticipating Infergen as a treatment...
Magnum
Glad to;
Vertex Fourth Quarter and Full Year 2008 Financial Results Conference Call
Monday February 9, 2009 at 5:00 PM ET
http://investors.vrtx.com/eventdetail.cfm?eventid=64988
If you want to listen to this you can also access it from vertex's home page.
The year end annual report usually has plenty of good news you may not easily find elsewhere.
I sometimes note at how many minutes certain announcements are made; none such for this. My recollection however is that the first announcement was early..... and then it was interesting/ compelling enough that there was a specific follow up question about it. The answer was that there are 3 2nd generation drugs; VX-500 (in trials, but perhaps now dropped) VX-813 and VX-985.
They didn't elaborate on whether the drug was a failure.... the answer was poised such that Telaprevir was so successful that VX-500 wasn't really worth developing because it wouldn't have a big enough niche that Telaprevir wouldn't already have.
They claimed that TVR made a 80%+ SVR rate in Europe under Tibotech (perhaps if you listen to the broadcast you can listen for the exact %). They claimed that drop outs were reduced...... and that BID (2 X/ day) dosing was as effective as TID dosing (3 X /day). I gathered that some of these upgrades eliminated the need for VX-500.
That's the long and the short of it although there was lots of other news; Josh Boger resigning as CEO, the Phase 3 trials will be over in 18 months(!!!), and some suggestions of future testing of TVR with a 4th compound perhaps this year.
It's a good listen, but if you want to do it catch it soon. These things get pulled after a relatively short period of time.
best,
Willy
Vertex Fourth Quarter and Full Year 2008 Financial Results Conference Call
Monday February 9, 2009 at 5:00 PM ET
http://investors.vrtx.com/eventdetail.cfm?eventid=64988
If you want to listen to this you can also access it from vertex's home page.
The year end annual report usually has plenty of good news you may not easily find elsewhere.
I sometimes note at how many minutes certain announcements are made; none such for this. My recollection however is that the first announcement was early..... and then it was interesting/ compelling enough that there was a specific follow up question about it. The answer was that there are 3 2nd generation drugs; VX-500 (in trials, but perhaps now dropped) VX-813 and VX-985.
They didn't elaborate on whether the drug was a failure.... the answer was poised such that Telaprevir was so successful that VX-500 wasn't really worth developing because it wouldn't have a big enough niche that Telaprevir wouldn't already have.
They claimed that TVR made a 80%+ SVR rate in Europe under Tibotech (perhaps if you listen to the broadcast you can listen for the exact %). They claimed that drop outs were reduced...... and that BID (2 X/ day) dosing was as effective as TID dosing (3 X /day). I gathered that some of these upgrades eliminated the need for VX-500.
That's the long and the short of it although there was lots of other news; Josh Boger resigning as CEO, the Phase 3 trials will be over in 18 months(!!!), and some suggestions of future testing of TVR with a 4th compound perhaps this year.
It's a good listen, but if you want to do it catch it soon. These things get pulled after a relatively short period of time.
best,
Willy
I hope to join you and Rocker as a Boceprevir experienced patient..., however right now, I am not allowed to be in their trials due to my previous exposure to a P.I. in the Prove-3 trial. Strange though about them not accepting past Infergen users as when I was in Prove-3 (Telaprevir), they were well aware that I was a past treater with Infergen, but I was told that they only wanted to see what had happened in my Peg treatments.... Maybe it has something to do with whoever from Vertex is the rep for your area? I don't have any idea? Susan400
Willy, I don't see a mention anywhere that Vertex dropped VX500. Do you have a reference/link for that?
The latest news I can find on the Vertex site is:
http://www.vpharm.com/current-projects/drug-candidates/vx-500.html
"VX-500 is a second-generation HCV protease inhibitor. Vertex has completed a Phase 1a clinical trial of VX-500. Vertex has initiated a Phase 1b clinical trial of VX-500 in patients with HCV and expects data from this study in the first quarter of
2009.
dointime
The latest news I can find on the Vertex site is:
http://www.vpharm.com/current-projects/drug-candidates/vx-500.html
"VX-500 is a second-generation HCV protease inhibitor. Vertex has completed a Phase 1a clinical trial of VX-500. Vertex has initiated a Phase 1b clinical trial of VX-500 in patients with HCV and expects data from this study in the first quarter of
2009.
dointime
Thanks to all for your encouragement. I need all I can get at this scary stage, which I'm considered at the start of Cirrhosis. Unfortunately, I had to give a 2-week notice to my job in order to keep my medical coverage. Only in America...
At any rate, I will report as to when I'm called to start and again, I want to thank all of you for your words of wisdom and encouragement. May we all clear soon. Never ever ever give up the battle. We will all be victorious in time...
Magnum
At any rate, I will report as to when I'm called to start and again, I want to thank all of you for your words of wisdom and encouragement. May we all clear soon. Never ever ever give up the battle. We will all be victorious in time...
Magnum
Magnum, I'm happy to hear that you were able to get into a trial. It will be a decided edge doing a treatment with a PI. I know that you may feel that really HAVE to treat now due to your staging. The only provision that I can think of is that if you thought that you could wait the 2 years to approval there could be a few possible benefits.
1) you could pick whichever drug you prefered and offered the higher efficacy (whetherTelaprevir of Boceprevir)
2) You could possibly treat with any other adjuncts; Metformin, alinia etc..
3) You could tailor your treatment meaning possible double or increased dosing in the crucial first months.
4) you would have more control over rescue drugs perhaps.
5) Data from the ongoing trials may suggest improved methods for treating slower responders. (I think Vertex may be doing a SOC lead in currently with past TX failures)
(also by the way....the European trials produced an 80% + SVR rate for niaves with fewer drop outs)
The bottom line is that you may only have one opportunity to do the PI's; make it your best shot.
I don't have an opinion on whether you should wait or TX. I know you are getting close to the edge and there is a lot to recommend about treating RIGHT NOW. I can't think of a better time to do it than during a phase 3 trial. Go for it; I think that I would. I just wanted to provide an opposing argument to wait..... simply so that you can make the better informed decision. My main advice is that if you do the trial do everything that you can to stay on full dose for as long as you can.
Best wishes....glad you have the opportunity.
Go get em,
Willy
(PS..... on the other issue; infegen and TVR.... I don't think that exclusions mean that the drug may not work on past infergen users. IF they exclude people...lets say for heart conditions it isn't that the drug won't work on people with heart disease.... but that they see that this group may be less likely to finish or have more complications. I don't know why they exclude infergen.... but I would resist drawing conclusions as to whether that means that it is a problem. Could be.... I have no idea; would love to know.
By the way Rocker....Vertex dropped their 2nd generation PI from development VX-500. They still have 2 more in preclinical development. That means the SP 2nd generation may be the top gun coming soon; well.... what 4 -5 years? There will be other great compounds to combine it with by then. - willy)
1) you could pick whichever drug you prefered and offered the higher efficacy (whetherTelaprevir of Boceprevir)
2) You could possibly treat with any other adjuncts; Metformin, alinia etc..
3) You could tailor your treatment meaning possible double or increased dosing in the crucial first months.
4) you would have more control over rescue drugs perhaps.
5) Data from the ongoing trials may suggest improved methods for treating slower responders. (I think Vertex may be doing a SOC lead in currently with past TX failures)
(also by the way....the European trials produced an 80% + SVR rate for niaves with fewer drop outs)
The bottom line is that you may only have one opportunity to do the PI's; make it your best shot.
I don't have an opinion on whether you should wait or TX. I know you are getting close to the edge and there is a lot to recommend about treating RIGHT NOW. I can't think of a better time to do it than during a phase 3 trial. Go for it; I think that I would. I just wanted to provide an opposing argument to wait..... simply so that you can make the better informed decision. My main advice is that if you do the trial do everything that you can to stay on full dose for as long as you can.
Best wishes....glad you have the opportunity.
Go get em,
Willy
(PS..... on the other issue; infegen and TVR.... I don't think that exclusions mean that the drug may not work on past infergen users. IF they exclude people...lets say for heart conditions it isn't that the drug won't work on people with heart disease.... but that they see that this group may be less likely to finish or have more complications. I don't know why they exclude infergen.... but I would resist drawing conclusions as to whether that means that it is a problem. Could be.... I have no idea; would love to know.
By the way Rocker....Vertex dropped their 2nd generation PI from development VX-500. They still have 2 more in preclinical development. That means the SP 2nd generation may be the top gun coming soon; well.... what 4 -5 years? There will be other great compounds to combine it with by then. - willy)
Boceprevir trials pay for the rescue drugs an no rashes..alto i think they only pay drug for the low red cells....not the white cells...and they will also let the whites drop lower before resue is needed
Congrats on the waiver; fantastic news. My heart dropped when I read your first post and am relieved you're getting the good stuff with a good medical team.
best of luck - looks like a great opportunity. Given Bill's recent thread you might ask about direct rollover instead of a do-over should that come up.
I am so glad that you are getting the waiver. I treated for 72 weeks Cedars and am very pleased with how they treated me.
Jennifer
Jennifer
Apparently the protocol for Schering-Plough's Bocepravir must be different. Again, no explanation from Cedars-Sinai, but they are preparing me to enter that trial, not the VX-950. I'm not questioning this decisionas it is in my favor.
Here is a VERY interesing cooment she made (the trial rep). She feels that Bocepravir is yet a more powerful drug against 1a than VX-950. Interesting....
Magnum
Here is a VERY interesing cooment she made (the trial rep). She feels that Bocepravir is yet a more powerful drug against 1a than VX-950. Interesting....
Magnum
Magnum........This means I'm eligible to enter the Bocepravir trial. YES!
Thats why i was confused, but anymore i'm confused alot.
Thats why i was confused, but anymore i'm confused alot.
My apologies...wahy was i thinkn you wre talkn bout the BOC,,,,,you were talkin teleprevir....finally brain fog has hit me.
Good for you!! So glad to hear you are eligible. It's been a long wait for you....I hope they get you started soon.
Will look forward to hearing good news from you.
Will look forward to hearing good news from you.
Little confused, are you talking about telaprevir as in your first post? Or has boceprevir decided to take you?
Either way both great drugs, congrats
Either way both great drugs, congrats
are you in this new trial....
Next-Generation HCV Protease Inhibitor SCH 900518
As part of its long-term commitment to hepatitis C therapy, Schering-Plough also is developing SCH 900518 ("518"), a next-generation HCV protease inhibitor. A Phase IIa study with 518, known as the NEXT-1 study, is currently ongoing. The company said that 518 has been shown to be 10 times more potent in-vitro than other protease inhibitors currently in Phase III development and has the potential for once daily dosing. 518 also has shown decreased emergence of resistance in vitro. Given its pharmacokinetic (PK) profile, the company anticipates that 518 may be active against some HCV strains that are resistant to other protease inhibitors. Phase I proof of concept studies with 518 in treatment-naive patients and those who failed prior treatment, both as monotherapy and in combination with peginterferon (without ribavirin), demonstrated enhanced antiviral activity, with up to 4 log10 and 5 log10 decreases in circulating HCV, respectively.
Full results of the boceprevir HCV SPRINT-1 study and early phase clinical results with SCH 900518 are being submitted for presentation at a future medical meeting
http://www.medicalnewstoday.com/articles/130622.php
Next-Generation HCV Protease Inhibitor SCH 900518
As part of its long-term commitment to hepatitis C therapy, Schering-Plough also is developing SCH 900518 ("518"), a next-generation HCV protease inhibitor. A Phase IIa study with 518, known as the NEXT-1 study, is currently ongoing. The company said that 518 has been shown to be 10 times more potent in-vitro than other protease inhibitors currently in Phase III development and has the potential for once daily dosing. 518 also has shown decreased emergence of resistance in vitro. Given its pharmacokinetic (PK) profile, the company anticipates that 518 may be active against some HCV strains that are resistant to other protease inhibitors. Phase I proof of concept studies with 518 in treatment-naive patients and those who failed prior treatment, both as monotherapy and in combination with peginterferon (without ribavirin), demonstrated enhanced antiviral activity, with up to 4 log10 and 5 log10 decreases in circulating HCV, respectively.
Full results of the boceprevir HCV SPRINT-1 study and early phase clinical results with SCH 900518 are being submitted for presentation at a future medical meeting
http://www.medicalnewstoday.com/articles/130622.php
Congrats! Looks like the presentence paid off. Man I give you kudos for having to go through this again and anyone else faced with treatment more than once.
jasper
jasper
Do you know exactly what BOC trial it is?....there is the new '518" one in the pipe.
Cool beans, Magnum. So glad to hear that.
I'm confused about the trial, though. I thought Shering-Plough had stopped recruiting and that the tx naive and relapsers Phase 3 trials are well underway. (I'm at almost 10 weeks on tx naive.) Are you in a *new* trial?
Oh--and a note. I'm also driving in (from Central CA) and when I went anemic (which is easy to do with the added boceprevir) they made me come in the next day or so and get the procrit and since then I've had to go in more often for blood draws to get my hgb levels sorted out.
I'm confused about the trial, though. I thought Shering-Plough had stopped recruiting and that the tx naive and relapsers Phase 3 trials are well underway. (I'm at almost 10 weeks on tx naive.) Are you in a *new* trial?
Oh--and a note. I'm also driving in (from Central CA) and when I went anemic (which is easy to do with the added boceprevir) they made me come in the next day or so and get the procrit and since then I've had to go in more often for blood draws to get my hgb levels sorted out.
God was lookn out for you....my prayers worked....LOL.....i am happpy for you...BIG TIME...this is your ticket my man
CONGRATULATIONS.....
CONGRATULATIONS.....
Good news! Just spoke to Cedars-Sinai hosp. in L.A. and they are going to disregard the last treatment I had with Infergen, and go with the previous Pegasys treatment. This means I'm eligible to enter the Bocepravir trial. YES!
It's been a long long struggle through four brutal treatments, and now there is hope. I thought I would pass this on after the scare I was given that they would only look at the Infergen treatment and disqualify me from any trial... I'm filling out the medial release form now... Stay tuned...
Magnum
It's been a long long struggle through four brutal treatments, and now there is hope. I thought I would pass this on after the scare I was given that they would only look at the Infergen treatment and disqualify me from any trial... I'm filling out the medial release form now... Stay tuned...
Magnum
I am sorry to hear this but to be honest I thought you had SVR some time ago and did not know you had treated 4 prior times with no avail. Let’s hope you get the waiver and be able to treat again. Try to stay positive.
jasper
jasper
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