Aa
Telaprevir Launch Could Be Delayed to 2012
This sucks!
http://money.cnn.com/news/newsfeeds/articles/apwire/da3e9a9e4c40232cc4c40734b0762a6c.htm
http://money.cnn.com/news/newsfeeds/articles/apwire/da3e9a9e4c40232cc4c40734b0762a6c.htm
I have been undetectable since week 2. I was randomized into the 48 week arm and I am now in week 40!! My experience wit Telaprevir has been nothing short of incredible after so many times treating with the current SOC flavor since 1989.
So -- lab-rat -- go for the rollover!! And, good luck to you.
merryBe: I just had the best investing week of my entire life!! I shorted the financial and real estated indexes on a 2 to 1 ratio on the day of the last FED meeting.
Eric
So -- lab-rat -- go for the rollover!! And, good luck to you.
merryBe: I just had the best investing week of my entire life!! I shorted the financial and real estated indexes on a 2 to 1 ratio on the day of the last FED meeting.
Eric
bad news in medical stocks is very good news to a select few.....
a common term, bottom feeding, is where my profits were often in excess of 100% in a matter of days. The trick was knowing how seriously the street would take the news, who concocted it, and what the real base line financials and research stats were. Then you estimate where the big financials and the lemmings (individual investors) will jump with that.
It's rather like trading IPO's except you can get in when the banks do, and without buying a thousand blocks at a time. Just don't put too many eggs in either of those baskets unless you know the risks,
congrats on your improvements by the way, you may the case well, as to relaspse retreatment.
Even if you VL went up a tad after being UND....do you get to continue to treat to "get all the abberant evil few" (to paraphrase HR) or do you have to stop the trial at 24 wks regardless?
a common term, bottom feeding, is where my profits were often in excess of 100% in a matter of days. The trick was knowing how seriously the street would take the news, who concocted it, and what the real base line financials and research stats were. Then you estimate where the big financials and the lemmings (individual investors) will jump with that.
It's rather like trading IPO's except you can get in when the banks do, and without buying a thousand blocks at a time. Just don't put too many eggs in either of those baskets unless you know the risks,
congrats on your improvements by the way, you may the case well, as to relaspse retreatment.
Even if you VL went up a tad after being UND....do you get to continue to treat to "get all the abberant evil few" (to paraphrase HR) or do you have to stop the trial at 24 wks regardless?
Thanks for clearing up my confusion.
dointime - you're correct I'm a relapser and I did respond to interferon. I was getting confused between the difference in odds of non-responders v. relapsers treating with PI's. I tend to skim over a lot of the information (which can do more harm than good).
Andiamo1 - I can't believe you've treated 7 times! I'm so glad to hear that this seems to be doing the trick for you - you're giving me hope. Thanks and good luck!
dointime - you're correct I'm a relapser and I did respond to interferon. I was getting confused between the difference in odds of non-responders v. relapsers treating with PI's. I tend to skim over a lot of the information (which can do more harm than good).
Andiamo1 - I can't believe you've treated 7 times! I'm so glad to hear that this seems to be doing the trick for you - you're giving me hope. Thanks and good luck!
Much as I hate stock analysts and think they are sleaze, I am aware that they are judged and financially rewarded based on the accuracy of their forecasts. The success of a drug or the company itself is irrelevant to them; only the direction of the stock price means anything. If an analyst downgrades a stock and the price subsequently drops, that is all that matters.
So I guess I mostly agree with you both with some differences based on my personal experience of going through an IPO of a telecom company during the go go days.
So I guess I mostly agree with you both with some differences based on my personal experience of going through an IPO of a telecom company during the go go days.
I think mr meets point was, most analyists don't CARE if they know what they are talking about.
they aren't being paid to care, only to make speculations and prognostications to drive market shares.
Drug approvals are highy speculative, meanwhile there's book to be made on the timelines.
If you understand traders, they trade on, and manufacture for trading purposes, both good and bad news....good or bad matters not...only something to trade TO trade on.
the market goes sideways and they still make billions...the ultimate spin doctors, it's all about the sell...knowing where the lemmings will all run to next....(because you told them which cliff to run off) and then getting there first yourselves.
they aren't being paid to care, only to make speculations and prognostications to drive market shares.
Drug approvals are highy speculative, meanwhile there's book to be made on the timelines.
If you understand traders, they trade on, and manufacture for trading purposes, both good and bad news....good or bad matters not...only something to trade TO trade on.
the market goes sideways and they still make billions...the ultimate spin doctors, it's all about the sell...knowing where the lemmings will all run to next....(because you told them which cliff to run off) and then getting there first yourselves.
I just listened to the webcast; Vertex has hired a senior exec from Novartis to take Telaprevir to market and he gave the presentation. Not much technical meat to it, but he did say that they are in advanced discussions with the FDA for phase 3 approval and that they are even further ahead in Europe. He also mentioned VX500, the follow on drug to Telaprevir, is already in phase 1 trials.
It certainly looks like most analysts don't know what they are talking about.
It certainly looks like most analysts don't know what they are talking about.
I just hope all those "naked shorters" realize one day they'll stand naked before..... Him....with no shorts, or jockeys either, to protect them.... : ))))))))))))))))))))))))))))))))))))))
The stats I was referring to were for my SOC treatment prior to the Prove 3 trial. On SOC, I continued undetectable until EOT and then relapsed after one week off treatment.
On prove 3 my viral load dropped from 8.2 million to <30 in one week and undetectable in two weeks.
Eric
On prove 3 my viral load dropped from 8.2 million to <30 in one week and undetectable in two weeks.
Eric
http://biz.yahoo.com/bw/080107/20080107005882.html?.v=1
Vertex Pharmaceuticals Reports Progress in Development of Investigational HCV Drug Telaprevir and Provides Business Update
Monday January 7, 8:01 am ET
- Formal European scientific advice obtained for telaprevir development program -
- Meeting scheduled with FDA for January 2008 on Phase 3 trial design and recent data -
- Next-generation HCV protease inhibitor and two investigational compounds for cystic fibrosis in clinical development -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced its key business objectives for 2008 and provided an overview of recent developments, including highlights from research and development programs, in conjunction with the 26th Annual JPMorgan Healthcare Conference in San Francisco. At the conference, Joshua Boger, Ph.D., President and Chief Executive Officer, and Kurt Graves, Executive Vice President, Chief Commercial Officer and Head, Strategic Development, will today review Vertex’s HCV product development and commercialization strategy. A live webcast of this presentation will be available on Vertex’s website, www.vrtx.com, today at 2:00 p.m. PST (5:00 p.m. EST).
--------------------------------------------------------------------------------------------------------------
The article is too long to post but it is juicy and worth a look, Boger does the presentation today and they also mention that they started dosing with VX-500. Looks like it will be a good presentation.
Willy
Vertex Pharmaceuticals Reports Progress in Development of Investigational HCV Drug Telaprevir and Provides Business Update
Monday January 7, 8:01 am ET
- Formal European scientific advice obtained for telaprevir development program -
- Meeting scheduled with FDA for January 2008 on Phase 3 trial design and recent data -
- Next-generation HCV protease inhibitor and two investigational compounds for cystic fibrosis in clinical development -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced its key business objectives for 2008 and provided an overview of recent developments, including highlights from research and development programs, in conjunction with the 26th Annual JPMorgan Healthcare Conference in San Francisco. At the conference, Joshua Boger, Ph.D., President and Chief Executive Officer, and Kurt Graves, Executive Vice President, Chief Commercial Officer and Head, Strategic Development, will today review Vertex’s HCV product development and commercialization strategy. A live webcast of this presentation will be available on Vertex’s website, www.vrtx.com, today at 2:00 p.m. PST (5:00 p.m. EST).
--------------------------------------------------------------------------------------------------------------
The article is too long to post but it is juicy and worth a look, Boger does the presentation today and they also mention that they started dosing with VX-500. Looks like it will be a good presentation.
Willy
Agreed with Mike. You qualify for an EVR by either account. Frankly, wouldn't you be an RVR as opposed to an EVR? After all, you cleared and stayed clear by week 2. (the qualifier for RVR is @ 4 weeks)
By the way....there is a Vertex teleconference today at 4 pacific time. I hope they give us a little insight into what's going on.
Best,
willy
By the way....there is a Vertex teleconference today at 4 pacific time. I hope they give us a little insight into what's going on.
Best,
willy
A 2 log drop or undetectable by week 12 is classified as EVR. The newer thinking based on studies is that complete EVR (undetectable by week 12) or cEVR is more predictive of achieving SVR than EVR so, perhaps we should alter our thinking and our decision making with that distinction in mind. Good luck to you, Mike
I had a two log drop by week 12 and undetectable by week 24 on SOC. Is that considered EVR?
I mixed my own conclusions with the Doc's. Sorry about that. His conclusion is that SOC fails due to our bodies inability to either deliver the drugs or our cells to process them properly, not due to interferon resistant virons. He also believes that relapsers stand a better chance with PIs than non - responders.
My observations of people in the prove trials seem to bear that out. I am not aware of anybody on triple therapy that was a previous relapser that did not have RVR. It there are any here, I hope they respond and give us more data. If there are any non - responders that experienced RVR on triple therapy I hope they comment here as well.
Jim: your effort to relate previous SOC treatment to probability of success with PIs through test results is admirable. I don't have the information to back that up or negate it. I think that will be an outcome of the Prove trials.
Eric
My observations of people in the prove trials seem to bear that out. I am not aware of anybody on triple therapy that was a previous relapser that did not have RVR. It there are any here, I hope they respond and give us more data. If there are any non - responders that experienced RVR on triple therapy I hope they comment here as well.
Jim: your effort to relate previous SOC treatment to probability of success with PIs through test results is admirable. I don't have the information to back that up or negate it. I think that will be an outcome of the Prove trials.
Eric
I don't claim to understand to understand it completely. I think that they are still trying to get a handle on quantifying exactly what it does mean. I agree Eric, it seems as if many people are simply equating the principle to mean that if you've treated with IFN in the past that you are "resistant" and that is just not so.
I think that it is also true (so this is me expressing an opinion or what I think I understand) is that even if one were to be a null responder that if one were to treat with a more potent form of treatment (for example with triple therapy TVR or Boceprevir) that one might still overcome the IFN resistant virii. If one had a group of 100 "null responders" the results might have a spread of results some failing completely, some failing but barely, some succeeding but barely and some succeeding perhaps even with RVR's.
It's all conjecture at this point I think but it will be less in conjecture once we get the results of the Prove 3's. The results have yet to be posted by Vertex but those that we've seen here on the membership suggest that past treatment failures respond to triple therapy and do so in a manner never seen before (and perhaps not seen in the Boceprevir trials as well).
Getting back to the main topic of the thread I believe that if the Prove 3 results are strong it should have a tendancy to keep the trials moving forward. A speedy trial and an effective treatment for prior failures should also equate to a raise in stock value. (obviously the opposite will also impact on stock price)
Willy
I think that it is also true (so this is me expressing an opinion or what I think I understand) is that even if one were to be a null responder that if one were to treat with a more potent form of treatment (for example with triple therapy TVR or Boceprevir) that one might still overcome the IFN resistant virii. If one had a group of 100 "null responders" the results might have a spread of results some failing completely, some failing but barely, some succeeding but barely and some succeeding perhaps even with RVR's.
It's all conjecture at this point I think but it will be less in conjecture once we get the results of the Prove 3's. The results have yet to be posted by Vertex but those that we've seen here on the membership suggest that past treatment failures respond to triple therapy and do so in a manner never seen before (and perhaps not seen in the Boceprevir trials as well).
Getting back to the main topic of the thread I believe that if the Prove 3 results are strong it should have a tendancy to keep the trials moving forward. A speedy trial and an effective treatment for prior failures should also equate to a raise in stock value. (obviously the opposite will also impact on stock price)
Willy
First sentence should read in part:
"... but that previous null-responders (those without a two-drop at week 12) will not respond when re-treated with triple therapy?
"... but that previous null-responders (those without a two-drop at week 12) will not respond when re-treated with triple therapy?
Is your doc then saying that EVRs on SOC (two log drop by week 12 but still detectible) who relapse will potentially do well on Telaprevir triple therapy
-- but that previous null-responders (<2 log drop at week 12) will not respond when re-treated with triple therapy?
---------------------------
If the latter, I wonder whether they will use the <2 log at week 12, as the cut off for null-response, or how they will fix that point?
Also, I've seen the term "interferon resistant" at times used somewhat synonmously here with "null response" -- but in fact there may be other reasons for null response, for example under-dosing with ribavirin.
If ribavirin underdosing is the reason for null response, then I assume that even this particular subset of null-responders could benefit from triple therapy -- Assuming, of course, that they can be identified, as opposed to those who are truly interferon resistant.
-- Jim
-- but that previous null-responders (<2 log drop at week 12) will not respond when re-treated with triple therapy?
---------------------------
If the latter, I wonder whether they will use the <2 log at week 12, as the cut off for null-response, or how they will fix that point?
Also, I've seen the term "interferon resistant" at times used somewhat synonmously here with "null response" -- but in fact there may be other reasons for null response, for example under-dosing with ribavirin.
If ribavirin underdosing is the reason for null response, then I assume that even this particular subset of null-responders could benefit from triple therapy -- Assuming, of course, that they can be identified, as opposed to those who are truly interferon resistant.
-- Jim
My Doc thinks that the issues with relapsers regarding SOC are not related to the virus becoming interferon resistant. He says that interferon does not attack the virus directly, but rather indirectly through our bodies own immune system and cell defense. The effectiveness of interferon is dependent on our bodies ability to deliver the interferon to the effected cells and the ability of our cells to use it.
PIs directly attack the virus and eliminate all but resistant virons quickly. This does cause resistance and interferon and ribaviron are required to eliminate the resistant virons. People with marginal ability to react to interferon do better with a PI in the mix. People who were null responders to interferon simply can't eliminate the mutant virons.
This seems like a reasonable explanation to me as to why relapsers on triple therapy all seem to respond very well to Telepravir.
I was only trying to counter the arguments that taking SOC once will make it impossible to treat with a PI. This is simply not correct.
PIs directly attack the virus and eliminate all but resistant virons quickly. This does cause resistance and interferon and ribaviron are required to eliminate the resistant virons. People with marginal ability to react to interferon do better with a PI in the mix. People who were null responders to interferon simply can't eliminate the mutant virons.
This seems like a reasonable explanation to me as to why relapsers on triple therapy all seem to respond very well to Telepravir.
I was only trying to counter the arguments that taking SOC once will make it impossible to treat with a PI. This is simply not correct.
I keep telling people about you, also the fact that you are 65ish and presumably have diminished immune response and yet you cleared handily and have so far stayed clear. Indeed....that has been the pattern for about all of you RVR (triple therapy) responders in the Prove 3 trial.
Strictly speaking your results speak to the issue of interferon resistance, not resistant virii to the PI's. The issue is that according to the studies....or what I have gleaned from peoples descriptions of them that there are "null" responders. These are people with very poor response rates with interferon. Technically, if you responded in the past you could still have failed TX but not fallen into that category.
One thing I see on this board is people perhaps misinterpreting the studies. I mean, I think the issues may exist but not in all people who have failed TX. It may also exist soon after treatment but it may become less of an issue over time. Just as bugs didn't immediately become immune or resistant to DDT overnight the virii may not forever and irrevocably become resistant to IFN. This does not mean however mean that the principle involved is invalid.
I think when telaprevir is added to the mix it will tend to trump any IFN resistant virii. The issue however may remain for people who have to quit triple therapy treatment prematurely and who do not succeed may have to find stronger treatments to overcome resistant strains of HCV. I think many of the principles involved with resistant bacteria and antibiotics will be seen in TX and HCV.
Best wishes by the way on your remaining TX and ultimate success.
Willy
Strictly speaking your results speak to the issue of interferon resistance, not resistant virii to the PI's. The issue is that according to the studies....or what I have gleaned from peoples descriptions of them that there are "null" responders. These are people with very poor response rates with interferon. Technically, if you responded in the past you could still have failed TX but not fallen into that category.
One thing I see on this board is people perhaps misinterpreting the studies. I mean, I think the issues may exist but not in all people who have failed TX. It may also exist soon after treatment but it may become less of an issue over time. Just as bugs didn't immediately become immune or resistant to DDT overnight the virii may not forever and irrevocably become resistant to IFN. This does not mean however mean that the principle involved is invalid.
I think when telaprevir is added to the mix it will tend to trump any IFN resistant virii. The issue however may remain for people who have to quit triple therapy treatment prematurely and who do not succeed may have to find stronger treatments to overcome resistant strains of HCV. I think many of the principles involved with resistant bacteria and antibiotics will be seen in TX and HCV.
Best wishes by the way on your remaining TX and ultimate success.
Willy
Seems like there's a lot of confusion about this. Lab-rat is a RESPONDER. Lab-rat did 48 weeks SOC and relapsed post tx. Lab-rat please correct me if I am wrong.
So interferon resistance is not the issue. Telaprevir resistance is the issue.
Well, that's how I read it.
dointime.
So interferon resistance is not the issue. Telaprevir resistance is the issue.
Well, that's how I read it.
dointime.
For the umpteenth time!!! I have treated 7 times with SOC prior to entering Prove 3. I was undetectable at week 2!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Does that sound like I am resistant??????????????????????????????????????????????????
I would like to know the answer to that also. According to some, even treating nonresponders with higher doses of interferon or ribavirin will not work.
I am very interested in the results of the telaprevir trials with nonresponders. I guess we will have to see 3 or 6 month post treatment results.
I am very interested in the results of the telaprevir trials with nonresponders. I guess we will have to see 3 or 6 month post treatment results.
"He explained if I treat now I would be interferon resistant and could not use the new drugs coming up inthe next few years"
I believe this is what the doctor meant. If you treat now and you do not respond, treating later with telaprevir or other PI's plus interferon, will not work for you. If you wait and use the telaprevir with your first try on interferon (treatment naive patients), the PI's may be enough to allow you to SVR. If a non-responder has complied perfectly, not had any dose reductions, and never had a 2 log drop, he is resistant to interferon and adding a PI will not work. Why it would work with a PI the first time is unclear to me. Perhaps HR would be able to explain.
I believe this is what the doctor meant. If you treat now and you do not respond, treating later with telaprevir or other PI's plus interferon, will not work for you. If you wait and use the telaprevir with your first try on interferon (treatment naive patients), the PI's may be enough to allow you to SVR. If a non-responder has complied perfectly, not had any dose reductions, and never had a 2 log drop, he is resistant to interferon and adding a PI will not work. Why it would work with a PI the first time is unclear to me. Perhaps HR would be able to explain.
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