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Good news for all - plans for 7977
There is great news for here everybody. By everybody, I mean all genotypes regardless of degree of liver damage or prior null response to interferon.
http://www.gilead.com/swf/fireside_chat.mp3
For those that don’t want to listen to the whole audio presentation, I have listed up the points that caught my attention most of all. There is much more information in the presentation.
-- Gilead expects filing for FDA approval of GS 7977 in late 2013 with approval to quickly follow in early 2014.
-- FDA has made regulatory pathways much easier to negotiate. The combination of dosing periods lasting only 12 weeks and FDA standards for SVR reduced to 12 weeks post treatment is ensuring quicker approval times. A 2013 release date for GS 7977 is a reasonable estimate of time rather than a "best" case scenario.
-- GS 7977 has displayed no significant side effects or adverse drug interactions to date. It is very safe.
-- Gilead is preparing to run 7977 trials for harder to treat Hepatitis C conditions without waiting for data from the other trials. These will include all the varieties of pre transplant conditions in Phase III. The goal is to release GS 7977 to be used for treating all genotypes at all stages of HCV disease progression from the start.
-- Gilead has a drug GS5885 which is effective for genotypes 1 and 4 which is a candidate for testing with GS 7977.
-- Trials involving GS 7977 will no longer necessarily involve an interferon arm but rather a placebo arm which turns around to a treatment arm after a period of time.
-- GS will try to pair some of the other GS drugs with GS 7977 or ribavirin with it.
-- Combining GS 7977 with BMS was not ruled out and studies continue.
-- Treatments involving Interferon will become unnecessary. In the near future Hep C will be treated with a two-drug combo lasting 12 weeks. Initially this may include Ribavirin but that will be replaced quickly by a number of less toxic alternatives. The treatment will be safe and simple so that many more people can be treated by a wider range of medical professionals.
Enjoy the new future. It is much much brighter!
http://www.gilead.com/swf/fireside_chat.mp3
For those that don’t want to listen to the whole audio presentation, I have listed up the points that caught my attention most of all. There is much more information in the presentation.
-- Gilead expects filing for FDA approval of GS 7977 in late 2013 with approval to quickly follow in early 2014.
-- FDA has made regulatory pathways much easier to negotiate. The combination of dosing periods lasting only 12 weeks and FDA standards for SVR reduced to 12 weeks post treatment is ensuring quicker approval times. A 2013 release date for GS 7977 is a reasonable estimate of time rather than a "best" case scenario.
-- GS 7977 has displayed no significant side effects or adverse drug interactions to date. It is very safe.
-- Gilead is preparing to run 7977 trials for harder to treat Hepatitis C conditions without waiting for data from the other trials. These will include all the varieties of pre transplant conditions in Phase III. The goal is to release GS 7977 to be used for treating all genotypes at all stages of HCV disease progression from the start.
-- Gilead has a drug GS5885 which is effective for genotypes 1 and 4 which is a candidate for testing with GS 7977.
-- Trials involving GS 7977 will no longer necessarily involve an interferon arm but rather a placebo arm which turns around to a treatment arm after a period of time.
-- GS will try to pair some of the other GS drugs with GS 7977 or ribavirin with it.
-- Combining GS 7977 with BMS was not ruled out and studies continue.
-- Treatments involving Interferon will become unnecessary. In the near future Hep C will be treated with a two-drug combo lasting 12 weeks. Initially this may include Ribavirin but that will be replaced quickly by a number of less toxic alternatives. The treatment will be safe and simple so that many more people can be treated by a wider range of medical professionals.
Enjoy the new future. It is much much brighter!
Not so fast willy...
Because hepatitis C has few treatment options, analysts have estimated the worldwide market for drugs such as VX-950 could be as high as $8 billion. If the clinical trials go smoothly, Vertex has said it could be ready to file for FDA approval in 2008.
http://www.natap.org/2006/HCV/020806_06.htm
Because hepatitis C has few treatment options, analysts have estimated the worldwide market for drugs such as VX-950 could be as high as $8 billion. If the clinical trials go smoothly, Vertex has said it could be ready to file for FDA approval in 2008.
http://www.natap.org/2006/HCV/020806_06.htm
Can do,
I have listened to many of the Vertex presentations; I never heard them mention a date. Rather, they would go out of their way to avoid mentioning dates or time tables. They were very conservative. No forecasts, they left info blinded more than other companies. People should have little to chastise them about. They were really very accurate. The ONLY time I heard one was about early 2008...... by Josh Boger, at the time the CEO of Vertex who thought that interferon might not be required by 2015. He was talking also about the VX-222 collaboration w/ telaprevir. You'll note thatthose 2 compounds are in Phase 2 trials, now with riba and there will be a presentation at EASL in April about the results. My guess is that VX-222 w/ Telaprevir and Riba may provide a measure of interferon free success in treating G-1 patients. I don't know if or when it could be approved, but if that trial is in phase 2 trials, phase 3 completion may be in the cards as well. I am not seeing that he was dramatically off base. (although time will tell)
I think that is in the area of correct.
One can read all sorts of nonsense on boards, but it is always from members. The stuff one hears in company presentations has been pretty accurate, from my experience.
Deb;
http://www.gilead.com/pr_1632335
"Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company's lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog,
has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients.
Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014."
(I could not BOLD FACE this and so I provided spacing for emphasis-willy)
willy
I have listened to many of the Vertex presentations; I never heard them mention a date. Rather, they would go out of their way to avoid mentioning dates or time tables. They were very conservative. No forecasts, they left info blinded more than other companies. People should have little to chastise them about. They were really very accurate. The ONLY time I heard one was about early 2008...... by Josh Boger, at the time the CEO of Vertex who thought that interferon might not be required by 2015. He was talking also about the VX-222 collaboration w/ telaprevir. You'll note thatthose 2 compounds are in Phase 2 trials, now with riba and there will be a presentation at EASL in April about the results. My guess is that VX-222 w/ Telaprevir and Riba may provide a measure of interferon free success in treating G-1 patients. I don't know if or when it could be approved, but if that trial is in phase 2 trials, phase 3 completion may be in the cards as well. I am not seeing that he was dramatically off base. (although time will tell)
I think that is in the area of correct.
One can read all sorts of nonsense on boards, but it is always from members. The stuff one hears in company presentations has been pretty accurate, from my experience.
Deb;
http://www.gilead.com/pr_1632335
"Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company's lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog,
has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients.
Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014."
(I could not BOLD FACE this and so I provided spacing for emphasis-willy)
willy
Yea Zacks is an Investment and Research Co so it totally makes sense that the Pharma companies wine and dine them and throw them their pitch. But Zacks is not the one to say...ok we approve this drug(s). It's the FDA and they are not concerned with the pharma's stock price.
Hopefully in the near future they will be able to approve less toxic drugs but in the meantime if you are tx I sure as hell wouldn't stop.
Hopefully in the near future they will be able to approve less toxic drugs but in the meantime if you are tx I sure as hell wouldn't stop.
I don't think anyone should stop treatment but if your liver can wait a few years, you might choose to delay it.
For those with little or no damage, this is great news.
For those with little or no damage, this is great news.
Folks before you stop treatment a few things you should know, as was noted Incivek (then vx-950) was fast tracked in 2005.
FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950
http://investors.vrtx.com/releasedetail.cfm?releaseid=190509
And then we had VERTEX claiming this.... From our insider " couldn't think of a nickname"
"To set the record straight, VRTX has said they anticipate filing for approval in 2008 (mid at the earliest I think), and it would be subject to expedited review, which is 6 months, instead of the normal year that is taken. That would take place after phase 3 is completed."
http://www.medhelp.org/posts/Hepatitis-C/Vertex-VX950-good-news/show/94488#post_728202
As you can see, fast tracked in 2005, vertex claiming filing for approval in 2008, so you can see why some hear don't get to excited when investors and even the drug company themselfs speak.... What was expected was 2008, what happened was mid 2011.
FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950
http://investors.vrtx.com/releasedetail.cfm?releaseid=190509
And then we had VERTEX claiming this.... From our insider " couldn't think of a nickname"
"To set the record straight, VRTX has said they anticipate filing for approval in 2008 (mid at the earliest I think), and it would be subject to expedited review, which is 6 months, instead of the normal year that is taken. That would take place after phase 3 is completed."
http://www.medhelp.org/posts/Hepatitis-C/Vertex-VX950-good-news/show/94488#post_728202
As you can see, fast tracked in 2005, vertex claiming filing for approval in 2008, so you can see why some hear don't get to excited when investors and even the drug company themselfs speak.... What was expected was 2008, what happened was mid 2011.
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