Aa
Vertex- Telaprevir Phase 3
(This is a long article and there will be many follow-up articles. For the complete article please go to the link I provide below--- Willy)
http://biz.yahoo.com/bw/080123/20080123005338.html?.v=1
Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational Hepatitis C Protease Inhibitor
Wednesday January 23, 7:00 am ET
-- Primary Phase 3 trial will focus on studying 24-week telaprevir-based regimens
-- Vertex plans concurrent second study to support registration
-- Final data from both trials anticipated in mid- 2010
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it will begin Phase 3 evaluation of telaprevir, Vertex’s lead investigational hepatitis C protease inhibitor. The primary focus will be a global, 3-arm pivotal controlled trial that will evaluate two 24-week telaprevir-based regimens in approximately 1050 treatment-naïve genotype 1 HCV patients. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks. A second study of approximately 400-500 HCV patients is planned to evaluate a 48-week telaprevir-based regimen, to confirm the results from Phase 2 studies and provide additional evidence that supports the 24-week regimen that is being evaluated in the primary Phase 3 trial. The Company expects that both studies will run concurrently and that the first trial will begin enrolling patients in March 2008.
“Data presented in late 2007 from two large Phase 2b studies suggest that telaprevir, dosed in combination with pegylated interferon and ribavirin, may be able to meaningfully increase the proportion of treatment-naïve genotype 1 HCV patients who achieve a sustained viral response, and also cut the current treatment duration in half, to 24 weeks,” said John McHutchison, M.D., Principal Investigator for the primary telaprevir Phase 3 pivotal study and Associate Director of Duke Clinical Research Institute. “Telaprevir is the most advanced protease inhibitor in development for hepatitis C, and the initiation of Phase 3 clinical development for this investigational drug will begin the process of helping to further assess its potential efficacy and the safety in a larger number of patients.”
Pivotal Trial to Evaluate 24-Week Telaprevir-Based Treatment Regimens
In accordance with the design and protocol Vertex submitted to the FDA, the primary pivotal trial will focus on evaluation of 24 weeks of telaprevir-based therapy and will enroll approximately 1050 treatment-naïve, genotype 1 HCV patients, who will be randomized equally across three treatment arms (approximately 350 patients per arm).
The study will be conducted at approximately 100 centers in the U.S., E.U. and certain other countries. The study arms will include:
24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of pegylated interferon alfa-2a (peg-IFN) and ribavirin (RBV) for 12 weeks, then continuing for another 12 weeks with peg-IFN and RBV alone;
24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 8 weeks in combination with standard doses of peg-IFN and RBV for 8 weeks, then continuing for another 16 weeks with peg-IFN and RBV alone; and
A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks.
Patients in both telaprevir arms who achieve rapid viral response (RVR), defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who stay undetectable at week 12 will receive 24 weeks of treatment. Patients in these treatment arms who do not meet the RVR criteria but are undetectable at week 24 will continue on peg-IFN and RBV for a total duration of 48 weeks.
Concurrent 48-Week Second Study to Support Registration
Vertex has agreed to conduct a second well-controlled clinical study as part of the registration program for a treatment-naive indication. The objective of this second study would be to develop additional sustained viral response (SVR) and relapse rate data with 48-weeks treatment duration that confirm results from the Phase 2 studies, thereby providing additional evidence supporting the 24-week regimen in the Phase 3 trial. The design of this second study is being finalized, but at this time Vertex expects this study to enroll approximately 400-500 patients, including patients in the control arm.
The primary objective of the two studies will be to assess the proportion of patients in each study arm who achieve SVR, defined as undetectable (less than 10 IU/mL, as measured by the Roche TaqMan® assay) HCV RNA 24 weeks after the completion of dosing. Vertex expects to have SVR data from both studies by mid-2010.
(once again, to read the complete article follow the link I provided at the top-Willy)
http://biz.yahoo.com/bw/080123/20080123005338.html?.v=1
Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational Hepatitis C Protease Inhibitor
Wednesday January 23, 7:00 am ET
-- Primary Phase 3 trial will focus on studying 24-week telaprevir-based regimens
-- Vertex plans concurrent second study to support registration
-- Final data from both trials anticipated in mid- 2010
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that it will begin Phase 3 evaluation of telaprevir, Vertex’s lead investigational hepatitis C protease inhibitor. The primary focus will be a global, 3-arm pivotal controlled trial that will evaluate two 24-week telaprevir-based regimens in approximately 1050 treatment-naïve genotype 1 HCV patients. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks. A second study of approximately 400-500 HCV patients is planned to evaluate a 48-week telaprevir-based regimen, to confirm the results from Phase 2 studies and provide additional evidence that supports the 24-week regimen that is being evaluated in the primary Phase 3 trial. The Company expects that both studies will run concurrently and that the first trial will begin enrolling patients in March 2008.
“Data presented in late 2007 from two large Phase 2b studies suggest that telaprevir, dosed in combination with pegylated interferon and ribavirin, may be able to meaningfully increase the proportion of treatment-naïve genotype 1 HCV patients who achieve a sustained viral response, and also cut the current treatment duration in half, to 24 weeks,” said John McHutchison, M.D., Principal Investigator for the primary telaprevir Phase 3 pivotal study and Associate Director of Duke Clinical Research Institute. “Telaprevir is the most advanced protease inhibitor in development for hepatitis C, and the initiation of Phase 3 clinical development for this investigational drug will begin the process of helping to further assess its potential efficacy and the safety in a larger number of patients.”
Pivotal Trial to Evaluate 24-Week Telaprevir-Based Treatment Regimens
In accordance with the design and protocol Vertex submitted to the FDA, the primary pivotal trial will focus on evaluation of 24 weeks of telaprevir-based therapy and will enroll approximately 1050 treatment-naïve, genotype 1 HCV patients, who will be randomized equally across three treatment arms (approximately 350 patients per arm).
The study will be conducted at approximately 100 centers in the U.S., E.U. and certain other countries. The study arms will include:
24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of pegylated interferon alfa-2a (peg-IFN) and ribavirin (RBV) for 12 weeks, then continuing for another 12 weeks with peg-IFN and RBV alone;
24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 8 weeks in combination with standard doses of peg-IFN and RBV for 8 weeks, then continuing for another 16 weeks with peg-IFN and RBV alone; and
A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks.
Patients in both telaprevir arms who achieve rapid viral response (RVR), defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who stay undetectable at week 12 will receive 24 weeks of treatment. Patients in these treatment arms who do not meet the RVR criteria but are undetectable at week 24 will continue on peg-IFN and RBV for a total duration of 48 weeks.
Concurrent 48-Week Second Study to Support Registration
Vertex has agreed to conduct a second well-controlled clinical study as part of the registration program for a treatment-naive indication. The objective of this second study would be to develop additional sustained viral response (SVR) and relapse rate data with 48-weeks treatment duration that confirm results from the Phase 2 studies, thereby providing additional evidence supporting the 24-week regimen in the Phase 3 trial. The design of this second study is being finalized, but at this time Vertex expects this study to enroll approximately 400-500 patients, including patients in the control arm.
The primary objective of the two studies will be to assess the proportion of patients in each study arm who achieve SVR, defined as undetectable (less than 10 IU/mL, as measured by the Roche TaqMan® assay) HCV RNA 24 weeks after the completion of dosing. Vertex expects to have SVR data from both studies by mid-2010.
(once again, to read the complete article follow the link I provided at the top-Willy)
I am a relapser after standard peg/ribo tx and am geno type 1b. My daughter is starting tx in the vertex pahse 3 trial in 3 weeks. The trial nurse has put me on the list for a trial for relapsers expected to begin towards the end of this year, so stay tuned, and get a good doc in a good teaching hospital!
I can't remember where I've posted it, but I was told, point-blank for the local rep for the Vertex (through my trial site doctor), "NO MORE Telaprevir trials for me" Even though, I agreed to be their guinea pig on Vertex Prove 3, I was randomized into Group 3 the (No-Riba Group), but I did get exposed to the Telaprevir. Because of that, they will not allow me to retreat with Telaprevir, using all 3 drugs. I think that this sticks IMHO. Because when you look at my unblinded report, you can see that my viral load went from the milllions of copies down to 195 copies on week 1. But, because of not having the Riba, I rebounded and was not clear at the week 4 requirement. I post this only because somebody else who was Group C, might be placing their hopes on getting into a later Telaprevir trial and it doesn't appear that this is going to be allowed, even on a non-responder trial (which was the one I was inquiring about getting into when it comes up in the near future). The only choice for those people will be to wait until it because FDA approved and to treat outside of the trial guidelines. Which who knows, if I'm not clear by 2010-2012, might very well be in my future. I have NO IDEA what the future holds. If I do ever treat with it again after it's FDA approved then I will use either Peg-Intron or Infergen and NOT Pegasys. Pegasys has never worked as well for me as Peg-Intron or Infergen, as far as my viral load goes. I can only speak of this, as my experience and that's what I'm doing here.
Susan
Susan
That I cannot tell you. I only heard about trials in England and I would venture that there will be trials again in about the same past trial sites. You may be able to check at clinicaltrials.com, type in "telaprevir ,Phase 2" and see where that past trial sites were. I believe that tibotech (or spelling close to that) is running the trials in Europe so if you see a trial designation that starts "ti-" then whateverf ollowing suffix it is probably a EU trail.
Vertex was reportedly not going to have a treatment failures trial in Phase 3 but they mentioned one forthcoming in the 3rd quarter of this year. It should be a great trial so find a location, chat with the trial coordinator, have your medical records in order. There is likely time to find a location and get in line for a slot. They do have criteria and exclusions you should also read and understand before you go to great effort or expense in finding a trial site. (for instance if you were a transplant patient, had diabetes, heart disease or other issues you could be excluded from a trial)
Sherring-Plough also is just starting a Phase 3 trial and it too has openings for past treatment failures. It may not be quite the efficacy of the Vertex trial but both should offer far better chances of clearing for past SOC failures. Their compound name is Boceprevir. Once again, search that as "boceprevir, phase 2" and you will likely see where the trials were held and their inclusion/ exclusions in trial design. You can then check the same under phase 3 but often by the time these things find their way into print on a page it's too late; the slots are filled.
Good luck, keep reading and searching and posting. By the way..... you can also contact people or leave your e-mail contacts off the board in your profile page. You can also contact people by clicking on their membername.
best,
Willy
Vertex was reportedly not going to have a treatment failures trial in Phase 3 but they mentioned one forthcoming in the 3rd quarter of this year. It should be a great trial so find a location, chat with the trial coordinator, have your medical records in order. There is likely time to find a location and get in line for a slot. They do have criteria and exclusions you should also read and understand before you go to great effort or expense in finding a trial site. (for instance if you were a transplant patient, had diabetes, heart disease or other issues you could be excluded from a trial)
Sherring-Plough also is just starting a Phase 3 trial and it too has openings for past treatment failures. It may not be quite the efficacy of the Vertex trial but both should offer far better chances of clearing for past SOC failures. Their compound name is Boceprevir. Once again, search that as "boceprevir, phase 2" and you will likely see where the trials were held and their inclusion/ exclusions in trial design. You can then check the same under phase 3 but often by the time these things find their way into print on a page it's too late; the slots are filled.
Good luck, keep reading and searching and posting. By the way..... you can also contact people or leave your e-mail contacts off the board in your profile page. You can also contact people by clicking on their membername.
best,
Willy
are teleprevir and albuferon avaiable in Republic of Ireland?? My father is sick, he is living in Poland, he already had therapy of interferon, he would like to know if its possible to repeat it with this new drugs. Thank you for any help.
Bea ***@****
Bea ***@****
The son is coming home from the hospital today. He's doing fine.
The trial locations will be listed at clinicaltrials.gov when they come out. For instance, here's a link to the Vertex "rollover" trial. It lists 50 sites where the trials occur.
http://clinicaltrials.gov/ct2/show/NCT00535847?term=Telaprevir%2C+VX-950&rank=5
The NEW trials are to take place in 100 locations world wide and so I think they will expand their base. It is presumed that any of the old locations will continued to be trial sites.
I hope as people keep an eye on the clinical trials site or an ear to when the phase 3 trials start we'll see a long list of the participating sites. They may fill up however quickly.
best,
willy
The trial locations will be listed at clinicaltrials.gov when they come out. For instance, here's a link to the Vertex "rollover" trial. It lists 50 sites where the trials occur.
http://clinicaltrials.gov/ct2/show/NCT00535847?term=Telaprevir%2C+VX-950&rank=5
The NEW trials are to take place in 100 locations world wide and so I think they will expand their base. It is presumed that any of the old locations will continued to be trial sites.
I hope as people keep an eye on the clinical trials site or an ear to when the phase 3 trials start we'll see a long list of the participating sites. They may fill up however quickly.
best,
willy
Main reason for posting.......going to get Shands to tell me what trials their 'thinking' on participating in. Despite the beotch nurses 1st answer "I can't give you that info. to post on a chat sight", if I get the right nurse, I'll get it :}
(DID tell her...'IT'S A MEDICAL INFO. SITE! NOT a chat sight!'....and a bit more :{
LL
sfbay...albuferen is Alina? ........No, it is interferon moleculed to albumin to stay even longer in your system, less shots, supposadly for better QoL, less sides, better SVR, but not proven just yet. Human genome sciences is backing/running this study...........
I am more likely to die of smoking than Hep C. So now I have to stop smoking.........
My next BATTLE also :}
Susan,......was wondering when you'd stray into this thread :}
My home is open, dear, you have to like animals tho....2 dogs. 3 'outside' cats :}
Thier all sweet. Been a 'sleepy head', right after that 'insomnia buddy' post! Decided I better go into rest/recluse stage a few days! See you soon!
Willy..........Mama Hated Deisels so Bad.....EASL, deisels, you sure your not on tx??
Glad your son came out well, fixed, okay.
Going shoping for some more DVD's :}
LL
I am more likely to die of smoking than Hep C. So now I have to stop smoking.........
My next BATTLE also :}
Susan,......was wondering when you'd stray into this thread :}
My home is open, dear, you have to like animals tho....2 dogs. 3 'outside' cats :}
Thier all sweet. Been a 'sleepy head', right after that 'insomnia buddy' post! Decided I better go into rest/recluse stage a few days! See you soon!
Willy..........Mama Hated Deisels so Bad.....EASL, deisels, you sure your not on tx??
Glad your son came out well, fixed, okay.
Going shoping for some more DVD's :}
LL
Hmmm. So from some here they may accept relapsers, like me, but it sounds like the short version of the vertex may not be as promising as expected. I would think relapsers would be going longer term as they have less of a chance of SVR. I have forgotten, it's late, albuferen is Alina? All the time here, I know I would love to find a Dr. to give me alina along with SOC and the protease inhibitors. What a combo! Hey, I will be a lab rat. As a slow responder and relapser what choices do I have? In my mind it is double dosing at first with interferon, more Riba than weight based and some Alina if I can get my hands on some along with a protease inhibitor. I don't want to do this again. my Dr. says interferon could be dangerous, so of course I want a short course.....this means PI, but for relapsers, does this mean that short term that native subjects got. Of course no one knows. I know I don't want to kill myself taking interferon, but will chance it with a lot of monitoring. Relapsers have a much less chance of clearing the virus and as Flguy did, I would follow his lead in doing so. Luckily I am a stage 1 (I think!) and have some time to reflect and wait for tx's. Women progress slower then men, I am told, and if I have had this disease for 30 years I am more likely to die of smoking than Hep C. So now I have to stop smoking.....Thanks for letting me rant. Still, I do want to rid myself of this bug.
I'll keep that in mind because if I don't get anything encouraging on my visit to Jacks. in April, I might be needing the number to your Dr. again, so that I can get my reg. gastro to refer me there in Gaines.
Take care, sleepy head!
Susan
Take care, sleepy head!
Susan
My last post was a little loopy. I was up late at the ER with a son who needed a appendectomy. When I posted at about 1:30 AM I was mildly delirious. I woke up and thought.....uh oh..... did I really post that silliness last night? (yup!)
By the way, the son had a successful opertion. I'm running on 4 hours of sleep but that's nothing compared to what many of you run on.
The Commander Cody song was "Mama Hated Deisels so Bad" (I think...that it had something....to do with Dad.....) : ) Not their best song by any stretch but Deisel does rhyme with EASL, at least it does at 1:30 AM.
When it comes to throwing cinema or music at the help Lauri........ I greatly prefer the VCR tapes (Beta is BEST!!) ........or for the traditionalists...... the classic 8 track tape. (what else can you do with them?) IF you must throw albums (frisbee style) be sure to properly jacket them first.
I'd discourage the practice however; it's hard on the help and hard on the furniture. : P
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By the way...... they printed a CORRECTION for the Yahoo article I led this thread off with.....and so I would be remiss in not including it;
http://biz.yahoo.com/ap/080124/vertex_pharmaceuticals_mover_corrective.html?.v=1
Correction: Vertex Jan. 23 Story
Thursday January 24, 1:30 pm ET
"NEW YORK (AP) -- In a Jan. 23 story about Vertex Pharmaceuticals Inc., The Associated Press quoted an analyst who erroneously said the Food and Drug Administration required the company to run an additional study on its drug telaprevir. Such a study was not required.
The story also erroneously reported that Wall Street analysts believe the drug may not prove superior to current treatments. The drug has already been proven to be more effective than current treatments, Vertex said.
In addition, the story erroneously reported that November results of a telaprevir study were mixed. The results were positive, not mixed, Vertex said."
---------------------------------------------------------------
We'll see how it plays out. I'll be watching for the list of centers that are participating in the Phase 3 trials.
I also would note......that one other pretty big aside from what I read or heard about the trials....... ( or THINK I read or heard it)
1) There seems as if there is going to be an embargo on information on the phase 3 trial results. That's one reason that some money people are pulling out.
2) The new trials may have the contruction in which ALL participants are "counted" whether they finish TX or not. The past results of Prove 1 and 2 (and possibly 3) ended up discounting people who didn't finish treatment. For instance even if a person treated and cleared and SVR'ed they might have been counted as a "failure" since they didn't finish the triple therapy. The results from the upcoming trials could be significantly better that the early ones.
Willy
'
By the way, the son had a successful opertion. I'm running on 4 hours of sleep but that's nothing compared to what many of you run on.
The Commander Cody song was "Mama Hated Deisels so Bad" (I think...that it had something....to do with Dad.....) : ) Not their best song by any stretch but Deisel does rhyme with EASL, at least it does at 1:30 AM.
When it comes to throwing cinema or music at the help Lauri........ I greatly prefer the VCR tapes (Beta is BEST!!) ........or for the traditionalists...... the classic 8 track tape. (what else can you do with them?) IF you must throw albums (frisbee style) be sure to properly jacket them first.
I'd discourage the practice however; it's hard on the help and hard on the furniture. : P
------------------------------------------------------------------
By the way...... they printed a CORRECTION for the Yahoo article I led this thread off with.....and so I would be remiss in not including it;
http://biz.yahoo.com/ap/080124/vertex_pharmaceuticals_mover_corrective.html?.v=1
Correction: Vertex Jan. 23 Story
Thursday January 24, 1:30 pm ET
"NEW YORK (AP) -- In a Jan. 23 story about Vertex Pharmaceuticals Inc., The Associated Press quoted an analyst who erroneously said the Food and Drug Administration required the company to run an additional study on its drug telaprevir. Such a study was not required.
The story also erroneously reported that Wall Street analysts believe the drug may not prove superior to current treatments. The drug has already been proven to be more effective than current treatments, Vertex said.
In addition, the story erroneously reported that November results of a telaprevir study were mixed. The results were positive, not mixed, Vertex said."
---------------------------------------------------------------
We'll see how it plays out. I'll be watching for the list of centers that are participating in the Phase 3 trials.
I also would note......that one other pretty big aside from what I read or heard about the trials....... ( or THINK I read or heard it)
1) There seems as if there is going to be an embargo on information on the phase 3 trial results. That's one reason that some money people are pulling out.
2) The new trials may have the contruction in which ALL participants are "counted" whether they finish TX or not. The past results of Prove 1 and 2 (and possibly 3) ended up discounting people who didn't finish treatment. For instance even if a person treated and cleared and SVR'ed they might have been counted as a "failure" since they didn't finish the triple therapy. The results from the upcoming trials could be significantly better that the early ones.
Willy
'
........As long as there is food, cable and a cabana boy to switch DVD's for you I see nothing wrong with that idea. : ) ..................................
Crackers, gingerale, apricot nector and chicken soup! And the cabana boy quit about 7th week of tx! He got tired of being hit with DVD's :}
..........Heyyyyyyyy....they called me about the albuferon trial about a year ago. Good point; .....
With the already drug 'phobia' I had, my fear was doing a 'trial' drug, so was actually glad to draw the tried and truer one! Geno 1, I'd be far more open to trials tho. Shands told me , thus far, the sides/QoL, etc. is looking about the same on albuferon, in their office anyway.
......I'll haver to put an ad in the paper; "wanted: friend to let me crash at their house, turn their heat up 7 degrees, keep VERY odd hours, refuse to share the remote, be subject to spontaneous but lovable "riba" moments and......quirky digestive issues. I'll bet there would be plenty of takers. How could they turn that down? ..................
As I have told Missy, Susan and others....anyone needs to go to Shands.....and needs help, I'm there :}
THO......with that add above, I may put Ambien in the herbal tea,lol!
And do you shampoo rugs at 4:00 am ?? :}
Do you remember that Commander Cody song;
"Mama Hated EASL's, So Bad?" ..............................
Uhhhhh, I can't remember my cabana boys name right now! Sing a verse :}
Hey! Did we know that Oct. 1, 2007 was world wide hepatitis awarness day? I don't remember that nor any post on it.
Instead of xoxo.......I'll sign with....
bxbxbxbxbxbxbx :}
LL
Crackers, gingerale, apricot nector and chicken soup! And the cabana boy quit about 7th week of tx! He got tired of being hit with DVD's :}
..........Heyyyyyyyy....they called me about the albuferon trial about a year ago. Good point; .....
With the already drug 'phobia' I had, my fear was doing a 'trial' drug, so was actually glad to draw the tried and truer one! Geno 1, I'd be far more open to trials tho. Shands told me , thus far, the sides/QoL, etc. is looking about the same on albuferon, in their office anyway.
......I'll haver to put an ad in the paper; "wanted: friend to let me crash at their house, turn their heat up 7 degrees, keep VERY odd hours, refuse to share the remote, be subject to spontaneous but lovable "riba" moments and......quirky digestive issues. I'll bet there would be plenty of takers. How could they turn that down? ..................
As I have told Missy, Susan and others....anyone needs to go to Shands.....and needs help, I'm there :}
THO......with that add above, I may put Ambien in the herbal tea,lol!
And do you shampoo rugs at 4:00 am ?? :}
Do you remember that Commander Cody song;
"Mama Hated EASL's, So Bad?" ..............................
Uhhhhh, I can't remember my cabana boys name right now! Sing a verse :}
Hey! Did we know that Oct. 1, 2007 was world wide hepatitis awarness day? I don't remember that nor any post on it.
Instead of xoxo.......I'll sign with....
bxbxbxbxbxbxbx :}
LL
"Something I want to read (and did, will again in am tho!) and have to crawl into bed with the remote and heating pad and hide! "
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As long as there is food, cable and a cabana boy to switch DVD's for you I see nothing wrong with that idea. : )
I'll haver to put an ad in the paper; "wanted: friend to let me crash at their house, turn their heat up 7 degrees, keep VERY odd hours, refuse to share the remote, be subject to spontaneous but lovable "riba" moments and......quirky digestive issues. I'll bet there would be plenty of takers. How could they turn that down?
(and they say that fish and visitors stink after 3 days.....)
I actually called my local teaching hospital..... and they are not in the game; No Vertex. That means I'm either going to have to wait, commute, or move.
Heyyyyyyyy....they called me about the albuferon trial about a year ago. Good point; sometimes it may pay to be in the control arm. I'll have to admit that I haven't been following that trial.
Must be about time to start longing for EASL again.....
Do you remember that Commander Cody song;
"Mama Hated EASL's, So Bad?"
Willy
-----------------------------------------------------------------------------
As long as there is food, cable and a cabana boy to switch DVD's for you I see nothing wrong with that idea. : )
I'll haver to put an ad in the paper; "wanted: friend to let me crash at their house, turn their heat up 7 degrees, keep VERY odd hours, refuse to share the remote, be subject to spontaneous but lovable "riba" moments and......quirky digestive issues. I'll bet there would be plenty of takers. How could they turn that down?
(and they say that fish and visitors stink after 3 days.....)
I actually called my local teaching hospital..... and they are not in the game; No Vertex. That means I'm either going to have to wait, commute, or move.
Heyyyyyyyy....they called me about the albuferon trial about a year ago. Good point; sometimes it may pay to be in the control arm. I'll have to admit that I haven't been following that trial.
Must be about time to start longing for EASL again.....
Do you remember that Commander Cody song;
"Mama Hated EASL's, So Bad?"
Willy
Something I want to read (and did, will again in am tho!) and have to crawl into bed with the remote and heating pad and hide!
Willy, you have any friends in the area's where their going to do these studies??? :}
24 weeks for Geno 1 would be huge, fantastic, along with SVR. (very foggy, have to re-read!)
Human Genome, hey that's my guys! Right now... I am glad I 'drew' the peg, not the Albuferon.
LL
Willy, you have any friends in the area's where their going to do these studies??? :}
24 weeks for Geno 1 would be huge, fantastic, along with SVR. (very foggy, have to re-read!)
Human Genome, hey that's my guys! Right now... I am glad I 'drew' the peg, not the Albuferon.
LL
Vertex is planning Phase 3 trials for non-responders later this year, according to the news articles. I'm sure it's dependent on data from PROVE3 but from all accounts on here, telaprevir shows a lot of promise even for those who have failed previous treatments. We just have to wait a little bit longer. Don't despair.
What is a non-responder to do?
Nothing here until mid-2010 or later being stated.
I really hate I went into both early treatments in '97 and again in '03. Now being proactive back then keeps me locked out of the Phase 3.
DARN IT!
Nothing here until mid-2010 or later being stated.
I really hate I went into both early treatments in '97 and again in '03. Now being proactive back then keeps me locked out of the Phase 3.
DARN IT!
I'm waiting to see this appear on clinicaltrials.gov so we can get the study locations.
Lots of people down under are hoping we are included.
Lots of people down under are hoping we are included.
One point in the reference to Albuferon. I think that the trial, and the expected go-forward dosing, is expected as biweekly not monthly as the article indicates.
"This pushes the timeline to approvals, and as that happens headline risks from competitors changes the competitive landscape, and others can catch up," added Jaikaria, who has a "hold" rating on Vertex stock.
Still, there has been much anticipation among doctors and patients based on earlier trial results that telaprevir, when added to standard treatments of interferon and ribavirin, will be able to halve the current treatment duration to 24 weeks with significantly higher cure rates.
"People appear to be spooked about the need for this other study and are worried that it might turn out to be a 12-month drug," said Sanford Bernstein analyst Geoffrey Porges, who called such fears unfounded.
Interferon is a notoriously difficult drug for patients to tolerate, so telaprevir's potential to halve treatment duration has been a prime source of excitement over the drug.
Vertex said it will begin enrolling the phase 3 trials in March, beginning with two 24-week studies involving 1,050 patients, which will be the primary focus of the program.
In those trials, patients will receive the Vertex drug in combination with pegylated interferon and ribavirin for 12 weeks followed by 12 weeks on the standard drugs alone.
After discussions with the Food and Drug Administration, Vertex also agreed to conduct a study of about 400 to 500 patients to evaluate a 48-week telaprevir-based regimen.
Shares of Cambridge, Massachusetts-based Vertex were down 11.8 percent to $19.74 in afternoon trading on Nasdaq after falling as low as $19.13 earlier in the day.
Human Genome shares were down $4.50, or 44.9 percent, to $5.52, also on Nasdaq. (Additional reporting by Varsha Tickoo in Bangalore; Editing by Jeffrey Benkoe/Tim Dobby
Still, there has been much anticipation among doctors and patients based on earlier trial results that telaprevir, when added to standard treatments of interferon and ribavirin, will be able to halve the current treatment duration to 24 weeks with significantly higher cure rates.
"People appear to be spooked about the need for this other study and are worried that it might turn out to be a 12-month drug," said Sanford Bernstein analyst Geoffrey Porges, who called such fears unfounded.
Interferon is a notoriously difficult drug for patients to tolerate, so telaprevir's potential to halve treatment duration has been a prime source of excitement over the drug.
Vertex said it will begin enrolling the phase 3 trials in March, beginning with two 24-week studies involving 1,050 patients, which will be the primary focus of the program.
In those trials, patients will receive the Vertex drug in combination with pegylated interferon and ribavirin for 12 weeks followed by 12 weeks on the standard drugs alone.
After discussions with the Food and Drug Administration, Vertex also agreed to conduct a study of about 400 to 500 patients to evaluate a 48-week telaprevir-based regimen.
Shares of Cambridge, Massachusetts-based Vertex were down 11.8 percent to $19.74 in afternoon trading on Nasdaq after falling as low as $19.13 earlier in the day.
Human Genome shares were down $4.50, or 44.9 percent, to $5.52, also on Nasdaq. (Additional reporting by Varsha Tickoo in Bangalore; Editing by Jeffrey Benkoe/Tim Dobby
UPDATE 2-Vertex hepatitis C trial timing disappoints
Wed Jan 23, 2008 2:45pm EST
.By Bill Berkrot
NEW YORK, Jan 23 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O: Quote, Profile, Research) said on Wednesday it will begin pivotal late-stage trials of its closely watched hepatitis C treatment, but data to be used to seek its approval will not be available until mid-2010, sending shares to their lowest level in more than two years.
Investors sent the stock down 14 percent, disappointed with a timeline that would not put the drug, telaprevir, on the market before 2011, and with a requirement by U.S. health regulators for a 48-week study in addition to anticipated 24-week trials.
Meanwhile, shares of Human Genome Sciences Inc (HGSI.O: Quote, Profile, Research) plunged 45 percent to a multiyear low on safety concerns involving its experimental hepatitis C treatment Albuferon.
An independent safety monitoring board told the company to modify its late stage trials to eliminate the highest 1,200 microgram dose after finding a higher number of serious adverse lung problems in that patient group.
The trials were continuing with those patients to receive a lower 900 microgram dose, but investors were clearly spooked by the safety signal and analysts said the possibility of once-a-month dosing -- a potential major selling point for Albuferon -- could be in jeopardy.
Vertex (VRTX.O: Quote, Profile, Research) shares have steadily declined since early September as news of potential competition for telaprevir emerged and as the start of the pivotal phase 3 testing program was pushed back later than prior expectations. They are now trading for less than half their value on Sept. 6.
"The bottom line is they had set high expectations for 24-week studies, so the 48-week timeline is obviously a disappointment for some investors," Rodman & Renshaw analyst Navdeep Jaikaria said. Continued...
Wed Jan 23, 2008 2:45pm EST
.By Bill Berkrot
NEW YORK, Jan 23 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O: Quote, Profile, Research) said on Wednesday it will begin pivotal late-stage trials of its closely watched hepatitis C treatment, but data to be used to seek its approval will not be available until mid-2010, sending shares to their lowest level in more than two years.
Investors sent the stock down 14 percent, disappointed with a timeline that would not put the drug, telaprevir, on the market before 2011, and with a requirement by U.S. health regulators for a 48-week study in addition to anticipated 24-week trials.
Meanwhile, shares of Human Genome Sciences Inc (HGSI.O: Quote, Profile, Research) plunged 45 percent to a multiyear low on safety concerns involving its experimental hepatitis C treatment Albuferon.
An independent safety monitoring board told the company to modify its late stage trials to eliminate the highest 1,200 microgram dose after finding a higher number of serious adverse lung problems in that patient group.
The trials were continuing with those patients to receive a lower 900 microgram dose, but investors were clearly spooked by the safety signal and analysts said the possibility of once-a-month dosing -- a potential major selling point for Albuferon -- could be in jeopardy.
Vertex (VRTX.O: Quote, Profile, Research) shares have steadily declined since early September as news of potential competition for telaprevir emerged and as the start of the pivotal phase 3 testing program was pushed back later than prior expectations. They are now trading for less than half their value on Sept. 6.
"The bottom line is they had set high expectations for 24-week studies, so the 48-week timeline is obviously a disappointment for some investors," Rodman & Renshaw analyst Navdeep Jaikaria said. Continued...
Adan Feuerstein thinks posibly mid 2011
http://www.thestreet.com/_yahoo/newsanalysis/thestreet-entrepreneur/10400013.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
The stock tanked today but remember that the whole market was down. At early morning it was down 7.7% and in spite of the bad news....Scherring-Plough who might have slid into 1st place......was down 5.7%.
It's all relative, subjective and very dynamic. As the Feuerstein article suggests; many investors are jumping out of Vertex simply because there will likely be very little data revealed until the endpoint of Phase 3.
best,
Willy
http://www.thestreet.com/_yahoo/newsanalysis/thestreet-entrepreneur/10400013.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
The stock tanked today but remember that the whole market was down. At early morning it was down 7.7% and in spite of the bad news....Scherring-Plough who might have slid into 1st place......was down 5.7%.
It's all relative, subjective and very dynamic. As the Feuerstein article suggests; many investors are jumping out of Vertex simply because there will likely be very little data revealed until the endpoint of Phase 3.
best,
Willy
"Vertex expects to have SVR data from both studies by mid-2010."
So supposing the data is good, best case scenario, what is a realistic date for the drug to get FDA approval and be available for use in the US?
dointime
So supposing the data is good, best case scenario, what is a realistic date for the drug to get FDA approval and be available for use in the US?
dointime
I agree with you on all counts.
I am heavily short the market and have been since last June.
I am heavily short the market and have been since last June.
Wait for the end of the day for the impact on the stock price. This share price often panics at any news. After investors have time to digest the conference call, the share price may well change. But any positive movement for any company is difficult in this overall market.
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