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Vertex v Schering - The Race Is On!
http://www.fool.com
By Brian Orelli
The marathon race to bring the next hepatitis C drug to the market is coming to a close. In the last couple of weeks, both Schering-Plough (NYSE: SGP) and Vertex Pharmaceuticals (Nasdaq: VRTX) have announced that their phase 3 trials have finished enrolling patients. That means investors can pretty much guess when data from the trials should be available.
Almost there
Schering's Sprint-2 trial testing boceprevir and Vertex's Illuminate trial testing telaprevir have a maximum of 48 weeks of treatment and a 24-week follow up to see if the virus has been eradicated, so the subjects that just started treatment now should be done in about 17 months. Add a month or two to process the data, and investors should get results before the end of the summer next year.
Both companies are also testing the drug in patients who have failed the current treatments: Roche's Pegasys and Schering's Pegintron. Vertex is expecting final data from a phase 2 trial, confusingly called Prove 3, in the first half of this year. It's still a possibility that the company could file a marketing application with just that data given the unmet need, but the company needs to see the data and discuss it with the Food and Drug Administration first. If it can get approved with the phase 2 data, great -- Vertex would likely be first to market. But if that doesn't work out, it has a backup plan with a phase 3 trial that is expected to be fully enrolled this quarter. Schering's phase 3 trial for treatment-failure patients concluded enrollment last November.
By Brian Orelli
The marathon race to bring the next hepatitis C drug to the market is coming to a close. In the last couple of weeks, both Schering-Plough (NYSE: SGP) and Vertex Pharmaceuticals (Nasdaq: VRTX) have announced that their phase 3 trials have finished enrolling patients. That means investors can pretty much guess when data from the trials should be available.
Almost there
Schering's Sprint-2 trial testing boceprevir and Vertex's Illuminate trial testing telaprevir have a maximum of 48 weeks of treatment and a 24-week follow up to see if the virus has been eradicated, so the subjects that just started treatment now should be done in about 17 months. Add a month or two to process the data, and investors should get results before the end of the summer next year.
Both companies are also testing the drug in patients who have failed the current treatments: Roche's Pegasys and Schering's Pegintron. Vertex is expecting final data from a phase 2 trial, confusingly called Prove 3, in the first half of this year. It's still a possibility that the company could file a marketing application with just that data given the unmet need, but the company needs to see the data and discuss it with the Food and Drug Administration first. If it can get approved with the phase 2 data, great -- Vertex would likely be first to market. But if that doesn't work out, it has a backup plan with a phase 3 trial that is expected to be fully enrolled this quarter. Schering's phase 3 trial for treatment-failure patients concluded enrollment last November.
At some point it may not be an "either/or" proposition; one may be able to treat with a PI and add or predose with Alinia.
I don't know if you have seen the Vertex results with past TX failures? The results look pretty "sexy" to me
I post a study (thank you, zazza) on the 107 Vertex trial which were the results for treatment failures in the Vertex Prove 1 and Prove 2 SOC "control arms". They were then given the chance to treat with triple therapy. The results were very good.... I think pretty promising even for past "null responders".
Please take a look at this study; it's a thing of beauty.
http://www.natap.org/2008/AASLD/AASLD_39.htm
It shows that there is indeed hope for past TX failures. If one more form of TX (such as a short course of an existing Polymerase inhibitor) could be added to this TX we could see an amazing cure rate.
The 107 study only goes to 24 weeks; no SVR rates.
The Prove 3 results may be revealed at the Spring EASL.
We may see final SVR rates for both studies soon.
We are still awaiting the results of the genotype 2 trials.
Vertex is also doing a trial in with 8 week triple dosing in naives.
I think they are trying out a SOC lead in as well.
hope springs eternal....
Willy
I don't know if you have seen the Vertex results with past TX failures? The results look pretty "sexy" to me
I post a study (thank you, zazza) on the 107 Vertex trial which were the results for treatment failures in the Vertex Prove 1 and Prove 2 SOC "control arms". They were then given the chance to treat with triple therapy. The results were very good.... I think pretty promising even for past "null responders".
Please take a look at this study; it's a thing of beauty.
http://www.natap.org/2008/AASLD/AASLD_39.htm
It shows that there is indeed hope for past TX failures. If one more form of TX (such as a short course of an existing Polymerase inhibitor) could be added to this TX we could see an amazing cure rate.
The 107 study only goes to 24 weeks; no SVR rates.
The Prove 3 results may be revealed at the Spring EASL.
We may see final SVR rates for both studies soon.
We are still awaiting the results of the genotype 2 trials.
Vertex is also doing a trial in with 8 week triple dosing in naives.
I think they are trying out a SOC lead in as well.
hope springs eternal....
Willy
I am more interested in Schering's Boceprevir at this point. Already tried Vertex's produce and got the rash and since I didn't have the Riba with it, didn't clear either. I'd rather take my chances with Boceprevir when it becomes available because it's not supposed to have so many rash issues with it.
Susan400
Susan400
Agree with Orleans on this. Romark should be making heaps out of Alinia
It Kills just about everything. H. Pylori, Giardia etc. And its safe.
Plus it doesnt generate Resistant mutations.
But I bet they are not.
CS
It Kills just about everything. H. Pylori, Giardia etc. And its safe.
Plus it doesnt generate Resistant mutations.
But I bet they are not.
CS
Selling lots? To who (or is it whom). Very few here are on it and I do not know a single 1st time TXer (other than myself) using it I am flabergasted at this as it is the only addition to SOC, readily available with at least SOME data supporting it. Oh there is a few one time, older things like the German thing with PPC. Stuff like that. SOCs low sucess rate was just too much for me to swallow and I was thankful to have an option. I turned down a spot in the Vertex trials and went for Alinia as the better choice. jerry
There are only three GT1's in the Alinia study and while they all cleared, that is not a number for me to get real excited about.
______________
And having we had the least a couple of geno ones who failed treatment here who took Alinia? I agree, hard to draw conclusions based on three people.
______________
And having we had the least a couple of geno ones who failed treatment here who took Alinia? I agree, hard to draw conclusions based on three people.
Romark may not have a need to drive up their stock price but I am sure that they are selling lots and lots of Alinia for HepC right now.
There are only three GT1's in the Alinia study and while they all cleared, that is not a number for me to get real excited about.
I wont be excited about Alinia until they show HCV clearance by a larger number of Geno 1's.
There are only three GT1's in the Alinia study and while they all cleared, that is not a number for me to get real excited about.
I wont be excited about Alinia until they show HCV clearance by a larger number of Geno 1's.
Oh, it was a lead in with just Alinia. Didn't get that.
You dont need the 12 week lead in no.
But we already knew that.
CS
But we already knew that.
CS
Looks like you are better off with less Alinia then?
Well Spotted.
Doesnt make sense though. the 12 week lead in arm had 61%
the 4 week lead in had 80%. Me thinks Romark have got it mixed up.
CS
Doesnt make sense though. the 12 week lead in arm had 61%
the 4 week lead in had 80%. Me thinks Romark have got it mixed up.
CS
Look closely at the 44 patient 4 week lead-in arm. Alinia + Peg, not SOC. The 24wk SVR data is in now. 80% svr, including all 3 G1s. jerry
Not sure you are right about the no Riba arm.
The 80% SVR rate was wth Riba
The no Riba had an svr rate of 61%.
Romark Announces Presentation of New Data For Nitazoxanide in Chronic Hepatitis C at EASL 2008
http://www.romark.com/news/04232008.aspx
Thirty-five of 44 patients (80%) treated with a 4-week lead-in phase of nitazoxanide followed by the addition of peginterferon for 36 weeks experienced a SVR 12 weeks after the end of treatment (SVR12)
compared to 50% in the SOC historical control group (P = 0.004),
61% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon,
and 79% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus SOC.
CS
The 80% SVR rate was wth Riba
The no Riba had an svr rate of 61%.
Romark Announces Presentation of New Data For Nitazoxanide in Chronic Hepatitis C at EASL 2008
http://www.romark.com/news/04232008.aspx
Thirty-five of 44 patients (80%) treated with a 4-week lead-in phase of nitazoxanide followed by the addition of peginterferon for 36 weeks experienced a SVR 12 weeks after the end of treatment (SVR12)
compared to 50% in the SOC historical control group (P = 0.004),
61% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon,
and 79% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus SOC.
CS
For some reason the PIs are "sexy". Not so with Alinia. I believe it is BECAUSE Romark is a private co. and has no need of stock moving hype. Granted the Romark trials have been small (they just don't have the mega $) but the results have been nothing less than stellar. 80% SVR in RibaLESS arm. Mostly G4s but all 3 of the G1s in that arm SVRed. NO RIBA! There early results in this country with G1s are due soon. jerry
I am with Orleans.
The rest of you can keep the damn PIs
CS
The rest of you can keep the damn PIs
CS
ill take 1000 shrae sof Schring please.
A lot of cold hard cash is gonna be made...and i mean alot....billions.
I'ld buy stock in Romark if it was a public co. jerry
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