Vertex VX-950 *Could* Bypass Stage Three Trials….
…. which would bring it to market earlier. Great news if it works, lets wait and see the SVR figures before we get too excited though.
Wall Street analysts still have high hopes for VX-950, a developmental-stage treatment for hepatitis C. Sales of VX-950 are expected to peak at $1.4 billion in 2011, according to McDonald.
The analyst said VX-950 has a chance of receiving regulatory approval earlier than expected if results of two upcoming mid-stage trials prove the drug’s efficacy, which would allow the company to circumvent a large-scale Phase III trial.
“This would give VX-950 a one-year advantage over the competition and the ability to reach a forecast $1.7 billion of sales by 2011,”
March 17th, 2006 at 9:36 am
I am very interested in the source of this information Can you point me to it?
Thanks
July 13th, 2006 at 7:49 am
I’M VERY INTERESTED IN VERTEX VX-950,, I HAVE HEP C,,, NEED HELP
August 2nd, 2006 at 3:02 am
how and when can i get vertex -950?
August 7th, 2006 at 6:35 am
Take a look here for details on clinical trials http://www.vpharm.com/clinicaltrials.html
September 11th, 2006 at 6:52 am
I have been through the peg intro with ribavaron for 48 weeks. It was not successful even when all signs said it was looking very good. I had some side affects but all in all did ok. Now 2 years later i fear that my time is running out if i dont do something soon. My biop. was between 3 & 4 when i started so time is a big concern. Please tell me when i can expect this vx-950 to be available. thx Dan ps would get into a study also…
September 26th, 2006 at 9:04 am
There are approximately 200 subjects currently participating in the VX950 Phase II trial. All subjects are treatment naive, with Stage 3 liver damage, and no other significant medical conditions. I’m one of them.
I started treatment as soon as drugs were available, and this is week 10 for me. Given that the treatment arms in the trial range from 12 weeks to 48 weeks, and follow up extends out to 102 weeks at the longest, it will be some time before final results are published.
All of us lab rats in the trial are seeing good labs, but VL results are blinded until week 10 for the 12 week treatment group and week 20 for the other three groups. I understand that there is a conference sometime in October where Vertex may present some initial results.
Its too early to tell with any certainty how effective this drug will be in clearing VL and achieving SVR. Us lab rats are hopeful, of course.
September 28th, 2006 at 7:09 am
APKhaos -
My husband is about to start a clinical study on VX 950. He is going to be a healthy lab rat!!!! Can you give me some info on your experience? SIde effects etc… (that is if you didn’t receive the placebo. ) I’ve done some research and it looks good. I don’t see adverse reactions or discontinued treatments - that’s a huge plus! I appreciate anything you can offer!
September 28th, 2006 at 8:15 am
Hey Staci!
I started with a totally clean set of labs for all factors except the HCV-related numbers. Good general health, fitness, good weight, and no significant medical history.
My sides have been typical of what other report - borderline anaemia, devlish riba itch, irritability, sleep problems, GI problems. These are all generally moderate at worst. The first 48 hours after the weekly peg shot can be rough. All of this appears to be realted to the peg and ribavirin, with no obvious sides from the VX-950 itself.
Fairly confident I’m getting VX drug based on comparing notes with other trial subjects on the taste and texture of the tablets. There are around 12 subjects at my clinic in a major teaching hospital’s liver center. Had one discontinue tx due to severe psych issues, but everyone else is rolling along.
My labs so far have been encouraging. AST and ALT dropped from 5X normal to low normal in four weeks, and have stayed there since. I wont know for 10 more weeks which arm of the trial I’m in, so stay tuned. Next Monday I’ll get the labs from the end of week 8, and draw blood for the end of week 10 labs.
My wife & family have had to put up with a bunch, and have certainly helped keep me moderately sane so far. This is my first experience of being less than robust, so its been a little hard to take in patches. Be prepared to give your husband a lot of support, and force feed him his body weight in ounces of water daily.
October 6th, 2006 at 1:02 pm
I can’t wait for VX 950 to become available.I live in fear of getting sicker or getting cancer.Iam not a candidate for Interferon therapy and VX 950 IS MY ONLY OPTION. I wish Icould participate in clinical trials.
October 16th, 2006 at 12:59 pm
Hey
my aunt just went thru the interferon treatment, and it was extremely tortuous for her and the side-effects were seriously debilitating. However, we still don’t know how effective it was.
Exactly what will VX-950 be able to offer if the interferon didn’t work and what has been learnt of VX-950 specific side-effects? I’d be grateful for any information
Thanks
November 19th, 2006 at 9:41 am
I am a non-responder to Peg/Interferon & Ribavirin due to low haemoglobin.
What do you think the chances are for me to be re-treated with VX-950?, I am feeling pretty desparate now.
November 29th, 2006 at 2:36 pm
I wish the FDA woould get the hell out of the way so this drug could be utilized by those who want to try it now. How many will die needlessly in the meantime or have thier health further compromised while we wait ? The choice should now be betweeen the patient and the doctor not the FDA.
Bill
December 4th, 2006 at 12:31 pm
I would be interested in getting into the testing program. Does anyone know of one?
December 26th, 2006 at 10:50 am
I am currrently in a clinical trial of VX-950. I am done with the 12-week regimen of the VX-950/placebo, but am still taking the convential therapy for an additional 12-36 weeks depending on which group I am classed in. Although my “viral load” numbers aren’t available to me until the trial ends, I do know that my ALT/AST levels started at 162/108 and as of my last available results (11-17-06) I am currently at 22/24—GREAT! I have to admit that when I recently visited my Gastroenteroligist to get my booster Hep A & B shots, I asked him to have me tested for my viral load. As of 12-21-06, I know my viral status is currently “undectable”. I had a very good Christmas with that news. I will continue in the study and hopefully I will be HCV free for life–no one can say for sure though.
I am very happy with the results and fully endorse this treatment. I truly hope this drug can get to market ASAP to help everyone out there with this virus. As for clinical trials, ask your doctor. Or do research like I did to find out about new drugs and studies. I know in the study I am in, we ended up with fewer people than expected—why was that? They cannot find you–you have to find them. These companies check with doctors to ask about qualified candidates–so see yours and ask about it each time you visit. In the meantime, do the conventional therapy–I know the ribaviran and interferon sucks, but a few months of crappy living is better than no living at all in the future. I am a 54-yr-old man. I want to see my grandkids grow. That is why I do it.
December 26th, 2006 at 6:48 pm
I was told last Friday that I have Hep C, and I am 59 years old. My count is 423,000 parts per ml.
As of 12/26/06 my VA Doctor said “your liver markers are ‘normal … AST = 44, ALT = 94, INR = 1.04, Albumin = 4.8. I would appreciate any comments anyone has about these numbers.
The Doctor told me that it is possible that a needle-pierce-prostate-biopsy, at the va, may have infected me with Hep C in the fall of 2005.
Also, is it possible that I may have contracted Hep C when I was an iv drug user in the 1970s, even though I have been straight and clean since 1977?
Also, I have had about 10 different female sex partners in the last 10 years, thank you very much.
December 28th, 2006 at 4:37 am
Hi Don, Find out your Genotype. Which type of Hep C do you have ? Type 2 is treatable , type 1 is tough. This vx950 study is all about treating type 1
January 14th, 2007 at 5:05 pm
Hi,
I had a liver transplant 2 years ago and I have been through the interferon-ribavirin treatment for 48 weeks.It was not succesful,had some side effects but in all was ok.Now two years later,hep.c is back ,I am om interferon to keep the virus low ,I fear that my time is running out if I do not do something soon.Please ,tell me if you know of any person with liver transplant on this Vx-950 study,I wish I could participate in clinical trials.Does anyone know of one?
Many thanks
Lod
January 17th, 2007 at 2:03 pm
I’ve been through 2 rounds of Interferon/Ribavarin treatments and, although the treatments have significantly slowed the rate of liver damage, I am considered a non-responder because the viral load bounced back after treatment. Does anyone know of a VX-950 trial for subjects who are not treatment-naive?
February 11th, 2007 at 9:45 am
Hello;
I am a artist. At 55 years old I am getting desparate. Major fatigue,Legs ache.Head ache, Cant seem to think properly anymore. Iam not ready to go yet. Too many things I want to do. Starting treetment shortly. I have been blood letting to relieve all the above symptoms for over year 1/2. This used to buy me 30 60 90 days. Now Iron levels are up in 9 days or les. How do you get on the VX950. I cant stall this off any longer. I will not make it. If I dont make it could some one out their down load my lifes work from myt web site and help keep it going. Keep the faith try to stay happy, Laughter helps. I see life differently now.
Love
Joseph
February 14th, 2007 at 7:54 am
Hello,
I have been treated two times so far, both clinical trails… I am so far a nonresponder. Sort of. The last treatment significantly lowered the viral load, but not low enough. My wonderful doctor has given me hope that vx-950 is the ticket. I sleep unreasonable hours, it is embarassing actually. I cannot commit to a conventional job because of my bodies ups and downs.
My hope is to get on this new miracle drug and dump this awful virus. Does anyone know if it is available beyond the US so we can all skip the beuracracy and get well? Like India or Europe, or better yet - Canada?
I will be looking… and share what I find. Good luck to all, and God bless you and your families.
February 14th, 2007 at 10:14 am
2 years post trans plant with for those of you that keep saying 48 weeks of treatment thats not true its 48 wks after you become undectable i
just finished 72 weeks of peg and ribi my liver tissue was sent to
california institute of genetics it came back neg the test is called super
quant just because your blood is clear doesnt mean its gone from your
liver thats where the virus lives to make sure you are completely clear this test has to be done, i had my transplant at that the universty of cinn
these people do not play any games you need a liver they will get you
asap i hope ive shed some light on the hep c confusion my email
adress is kinged@ameritech.net if anybody wants the real scoop
liver transplant clinic phone# is 513 584 9999 8 am unti 4 pm
god bless all of you
ed king
February 16th, 2007 at 2:28 pm
VX-950 should be in clinical trial in LA, Ca. this spring.
Hope sooner but cannot get firm start date.
I have been on Int / Reb before but virus came back.
Tried another clinical trial in OC but that didn’t work for clearance.
We should all keep trying to be rid of the virus, no matter how long,
how crumy or moody it makes one feel. It will shorten our life and I want
to be rid of it. Been having effects from it for over 28 years.
I like your site and will come back. Thanks for keeping it up.
Best to all fellow heppers,
TBB
March 15th, 2007 at 8:03 pm
I am 50 and 7 years ago diagnosed with C , under went renal splenal shunt, DSS due to internal bleeding. Feel good most times. Have recently considered interferon treament but thinking about holding out for vx950 to avoid side effects that may ccause work related issues. I understand that some say vx950 is primarily targeted to cure geno type 1. I have geno type 3. What is your suggestion in regards to treatment types.
March 16th, 2007 at 8:33 am
Tough questions Stan.
I think you are going up the wrong path side effect wise, remember vx 950 will be in addition to the current drugs not instead of. The treatment *may* be shorter but maybe not.
Your right about the targeting at geno 1’s, as I understand it that is all it will work with. It works by blocking an area on the virus, like how a jigsaw puzzle fits togther, I assume the puzzle is different for geno 3’s. I don’t see anything short term for genos other than 1, frankly the market isn’t that big from a return on investment perspective.
My advice would be to look again at current treatment options and also make sure you are aware of the current state of your liver, preferably via a biopsy.
March 16th, 2007 at 7:56 pm
I have been told by my physician that geno type 3 has a higher cure rate vs. 2 or 1 and I find on-line articles that convey the same message. Do you know if this is the case? Also, my doctor says that we could achieve results in as little as 4mo.s or could take 6. Which of course we will then have to wait to see if results are sustained. I have now requested a biopsy before considering starting treatment. Do you know if another treatment is currently available other than inter-feron/riboviran and is there any new treatments other than vx950 being researched and/or tested now or in the near future?
March 16th, 2007 at 8:18 pm
Just one more question if you please. Vertex states that vx950 can be used alone. Now, I have read that it is used in conjunction with interferon treatment for a better response and cure rate, but what cases are treated with vx950 alone?
March 18th, 2007 at 3:47 pm
Usual disclaimer applies.
>geno type 3 has a higher cure rate vs. 2 or 1
I think its broadly similar to geno 2 at about 80%, geno 1 is just about 50%.
>Also, my doctor says that we could achieve results in as little as 4mo.s or could take 6
Yes if you respond rapidly, normally undetectable at week 4 of treatment, and your starting viral load was low then 16 weeks is an option.
>requested a biopsy
I think thats a good move. There is a slight risk with a biopsy but very small more than balanced out by knowing what you liver damage is. Sometimes that can make these very difficult decisions easy, I have Cirrhosis so not treating wasn’t really an option, you could have almost no damage and may be able to afford to sit it out.
>Do you know if another treatment is currently available other than inter-feron/riboviran and is there any new treatments other than vx950 being researched and/or tested now
Nothing other than interferon - ribavirin works at the moment. There are quite a few other drugs in trials but realistically years away [as is vx 950 to be honest]. The main problem I see with you and future drugs is your geno 3, it is a fairly small proportion of the population and I think research and new drugs may well lag behind.
>but what cases are treated with vx950 alone
None. It just won’t work on its own. I don’t think we will see a treatment without interferon for many many years. They are running some european trials without the ribavirin, that will be interesting and a big leap forward as that ribavirin ain’t th most pleasant stuff.
I hope I’m not sounding too downbeat, things for you could be a lot worse. I would honestly suggest you wait for the biopsy results and see what they say. If you have to treat you have to and its not as bad for the vast majority as you may have read. About 20% have no sides at all, 20% really struggle and the rest get by. You have an 80% chance of getting a relatively easy ride with an 80% chance of a cure, if that was a poker game I’d be putting a good bet on your hand.
March 21st, 2007 at 7:14 pm
Good luck to all of you on treatment, best wishes to all of you who have beat it, and prayers to all who are still struggleing.
I’m in my late 40’s; I found out I had HCV 10-12 yrs ago…don’t know where it came from (???).
I’ve read all your entries but haven’t heard one person mention geno type 4 — this is what I have.
I have no symptoms and although I keep my eyes open for any new onfo., I have not looked into treatment yet.
I stumbled across vx 950 a couple of yrs ago, just as I stumbled onto this interesting site tonight…
My question: What does geno type 4 mean compared to geno type 1, 2 and 3 and if these meds are for 1, 2 and 3 where does this leave me?
No doubt, I’ll have to bite the bullet eventually and seek treatment.
At this point I’m beginning to think the sooner the better for fear of starting in with symptoms…but where’s info /studies on geno type 4?
From my heart, I wish the best for all of you.
March 31st, 2007 at 8:51 am
I read your response to “tough questions Stan” on March 16, you state:
“Your right about the targeting at geno 1’s, as I understand it that is all it will work with. It works by blocking an area on the virus, like how a jigsaw puzzle fits togther, I assume the puzzle is different for geno 3’s. I don’t see anything short term for genos other than 1, frankly the market isn’t that big from a return on investment perspective”.
My question is: “Have you heard this from Vertex”? I agree that the vast majority of Heppers are genotype 1, and thus that is why the current studies only include genotype 1’s. Obviously, that’s where the money is to be made.
However, that’s not to say that Vx-950 won’t work for genotypes 2 and 3.
I’m a genotype 2b. I was treated with the Pegylated Inerferon / Ribavirin combo, undetectable at 12 weeks, but relapsed after completion of 24 weeks of treatment. Yes, relapse is not supposed to occur in genotypes 2 and 3 who have reached undetectable status by 12 weeks, but it happened to me. I know of another hepper (also genotype 2b) who participated in a study, and thus had a PCR taken at week 4 of treatment, at which time she was undetectable. Because it was a study, she did a 48-week treatment. Shortly after completion of treatment she also relapsed.
I seriously wonder about the numbers related to genotypes 2 and 3, and SVR. I have come across quite of few heppers via liver support groups, forums, and chat groups who have relapsed.
Getting back to the subject of Vx-950, have you specifically heard from Vertex that Vx-950 will not be effective in the case of genotypes 2 and 3?
I was hoping it would be my silver bullet.
Thanks,
TP
April 17th, 2007 at 1:44 pm
There are “studies” starting. Try to get enrolled.
Vertex will cover cost so if you can get VX-950, free.
One only need to stay the course…..
Good luck to all fellow hepers. Fight the dragon!
April 21st, 2007 at 4:02 pm
here is a website that may answer some of your questions about vx950….
http://www.natap.org/2007/EASL/EASL_17.htm
Just last week I went to Shands in Gainesville, FL. I was interviewed for the next trials for this new drug. There are two trials coming soon, late summer. One will be a double blind study the other will treat everyone the same. The doctor that I saw had attended the conference in Barcelona and said that he was very encouraged with everything he had learned. He said that in just a few years the drug will be available here and it is already being used in europe. I was told that I met the criteria to enter the trials and that I would be contacted for admission in a few months….I will keep you posted….bless you all and good luck…..
April 28th, 2007 at 10:08 am
Hi Hep C Boy. I was searching for information on VX-950 and the data presented at Barcelona and saw your blog listed. First I want to say thank you for maintaining a site for information on Hep C. I don’t know if you have published more information on VX-950 since the EASL in Barcelona last month (I just linked to this page straight from a search engine) but from what I have been gathering these past few weeks (since that conference) is that there will be no “bypassing” (or “circumventing” as market analysts have forecasted and as many had hoped for) of a Phase III (not that that would slow things up as far as marketing, but my worry is - that it could.)
Do you have any information on this (Phase III) and if so - could you please post it? Also, do you think it’s reasonable to think that if Vertex files for an NDA in 2009 as they’ve stated they hope to, that VX-950 will be on the market by 2010? I have heard 2010 / 2011, possibly later. Thanks for anything you can add.
May 2nd, 2007 at 9:19 am
I have read that VX-950 has fast track from FDA and will be on the
market, 2008. At least that is the plan from Vertex. I will be starting
soon, on a four arm study. Should know more soon, like which
arm of study I will be in. Double blind, using VX-950, with the
current treatments. The fight with the dragon will begin, again.
This could be a much longer treatment course and battle.
6 — 100 weeks is what I signed, on 4-10-2007.
Fight on, fellow hepers. Do not give up!
May 4th, 2007 at 8:15 am
Hi. Just one question, please. Started Phase 2 Study
of Telaprevir yesterday. Yes, it is with Peg & Ribavirin.
Can anyone tell differance between VX-950 & the
Placebo? Just wondering which I am taking.
Thanks, TBB
May 4th, 2007 at 9:07 am
Myself and my daughter both found out we had HCV about 5 years ago. Since that time we have both done Pegintron and riba. We both were undetectable at 48 wks. but relapsed. My daught who is 19 now but the time was 12 was also put on Infergen but it did not work at all. We are now waiting for the trial for VX950 to start…..we were told we will start treatment in about 2 weeks. We are going to Cedars Sinai in Los Angeles. We are both geno type 1a. Who commented about the trial being skipped over because the first 2 went so well. I would like more info on that……makes me wonder if we really be starting our meds in 2 weeks. Will keep you updated. Keep on fighting all!
May 23rd, 2007 at 12:43 pm
Just talked to the nurse for the phase 2 study. the study was full as of last week. I hope to get into phase 3 study in ~6 mos. i’ve done 3 battles with interferon and 2 included riba. I was a non-responder. I’m hoping for a cure like all of you. If time is on or side, hopefully there will be an end to this.
June 13th, 2007 at 9:19 am
Can anyone tell me where or when the So Cal study will be . Phone # address ??
June 18th, 2007 at 12:12 pm
My wife has Genotype 3A. It’s wrong to assume telaprevir(Vertex 950) will only be effective for genotype 1. Vertex had a press conference in April announcing that in vitro tests showed the drug was as effective for genotypes 2, 3 and 4 as it is for genotype 1. That’s why they are beginning clinical trials for genotypes 2,3 and 4 this year.
June 22nd, 2007 at 8:46 pm
did combo 1998 3 shots weekly relapsed did com 72 weeks negative for 46 weeks relapsed sept 05 wife died while on treatment reduced fibrosis stage 1 97 to no fibrosis may 07 now on vx950 trial as of may 15 07 not sure what arm yet as you see even if treatment fails can still do your liver alot of good and buy time last biopsy was done in order to qualify for trial
July 4th, 2007 at 2:25 pm
Thank you to Hep C Boy for all the info shared. It is helpful to learn as much as possible in this battle against HCV. So many of us are hit hard with the news from our doctor that we are infected with Hepatitis C. Worse is not knowing how or when it happened…
Hope is on the horizon with Telepravir (VX-950) and soon may not be soon enough! With so many of you I am praying that Vertex, as well as all the other reseach labs out there, will succeed in finding a cure for Hep C - It is a silent epidemic that has spread too far.
In my reading, what surprised me most was that no one mentioned anything about alternative treatments such as herbal / ayurvedic / homeopathic … options. I’ve read about the benefits of Milk Thistle to help repair Liver cells, but are there any natural options that can cure Hepartitis C?
I find it hard to believe that the only option lies in waiting for the scientists to create a cure and the FDA to approve it (They do not always approve the safest medicines….(e.g. Vioxx)
July 18th, 2007 at 3:43 pm
Has Johnson & Johnson/Vertex publicly speculated on FDA approval time window? How do we (HCV carriers) calculate on waiting for vx 950 versus embarking on the 50-50 chance (geno 1) & nasty side effects of the currently available treatments? Thanks for sharing…
July 23rd, 2007 at 9:15 am
Talk to your doctor. Wait for VX-950, if you can. It will better your
odds for SVR. Also, it will be in cobo with Inf / Rib so do wait,
if your doctor thinks you can, which will be your best bet.
August 12th, 2007 at 8:11 pm
I,m a 41 yrs. young at heart and and just had a baby 6mnths ago. I have geno 2.The baby showed no sighns of yellow jondis that I,ve heard if a woman pregnant could pass it on I think its about 10% chance .I pray this is true because she,s a miracle for what I,d went through having a stroke and finding out I was HEP C positive but, enough about that because GOD has been GREAT to me and my family. I start next week on my treatments 6mths of Interfaron &ribiviron .Can someone explain to me thats taken the treatments and what to expect to feel like when I first start ,you know like nausia ,or any other discomforts. and thanks to any input and GOD BLESS EACH AND EVERYONE OF US!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
August 18th, 2007 at 12:08 am
Hi I’ve had hep c for 20 years now and it got worse about 10 years ago whan I found out about it. I have been managing it with Qi Gong and Chinese herbs - and feel so much better compare to when symptoms kicked in. I am from London and everybody there is waiting for Vertex as well . Darlene, would love to hear about your trial and what side effects you had. Good luck!
October 19th, 2007 at 9:54 am
I never got word of the vx 950 study @ U of FL…I must have been passed over. I have options for other clinical studies using Polymerase inhibitor drug. I have been looking online for study results from these drugs. Does anyone have any info about them….any personal experience with these new drugs? Please post asap….wondering if they will do more harm than good?
January 16th, 2008 at 1:57 pm
Vertex shares rise after upgrade
January 16, 2008 12:07 PM ET
advertisement
Article tools
* E-mail this article
* Print-friendly version
* Discuss this article
Stocks mentioned in this article
InterMune Inc (ITMN) Stock Quote, Chart, News, Add to Watchlist
Schering-Plough Ord Shs (SGP) Stock Quote, Chart, News, Add to Watchlist
Vertex Pharmaceuticals Inc (VRTX) Stock Quote, Chart, News, Add to Watchlist
Related topics
Associated PressAll Associated Press news
NEW YORK (AP) - Shares of biotechnology company Vertex Pharmaceuticals Inc. rose Wednesday after Banc of America Securities upgraded the stock, citing a positive forecast for the hepatitis C drug candidate telaprevir.
Shares rose 99 cents, or 4.4 percent, to $23.72 in midday trading. The stock has traded between $20.71 and $41.42 over the last 52 weeks.
Banc of America analyst William Q. Sargent upgraded the stock to “Buy” from “Neutral” and raised the price target to $34 from $29, citing increased confidence that upcoming study results will drive shares higher.
The company’s key drug candidate is telaprevir. Positive results from a midstage study could be released in the second quarter, according to the analyst. Sargent also expects the Food and Drug Administration to approve late-stage studies for the drug candidate.
“Telaprevir’s market leadership may be under-appreciated,” he said, in a note to investors, adding that recent discounts to Vertex shares have created a buying opportunity for investors.
Cambridge, Mass.-based Vertex faces competition from Schering-Plough Corp., which is conducting midstage studies on its hepatitis C drug candidate boceprivir. Results are expected later this year. InterMune Inc., meanwhile, is still in the early stages of development for its experimental drug ITMN-191.
Based on data already available for telaprevir, Sargent said, the drug should be able to clear hepatitis virus more effectively than current treatments, and may even receive a quicker review process by the Food and Drug Administration. Despite that possibility, he shifted expectations for approval to early 2011 from late 2010.
Elsewhere, on Tuesday Robert W. Baird analyst Thomas Russo initiated coverage on Vertex with a “Neutral” rating and $25 price target, saying telaprevir has multi-billion dollar potential and will be adopted quickly if approved.
Analysts expect Vertex to provide an update on its late-stage study design for telaprevir Feb. 11.
Lazard Capital Markets analyst Terence Flynn reaffirmed a “Sell” rating with a $16 price target for Vertex while touting a “Buy” rating and $30 price target for InterMune.
He said telaprevir’s launch will most likely occur after 2010, and initial details show the late-stage study design could be more cumbersome than initially expected. InterMune, meanwhile, will likely successfully develop a twice-daily dosing schedule for ITMN-191, he said. The company has been working on both twice-daily and three-times per day dosing.
Shares of Brisbane, Calif.-based InterMune rose 25 cents to $18.97, while shares of Kenilworth, N.J.-based Schering-Plough rose 10 cents to $23.88.
© 2008 The Associated Press. All rights reserved. This material may not be publ
January 21st, 2008 at 2:15 pm
The Next Hepatitis C Blockbuster?
By Brian Lawler October 31, 2007
16 Recommendations
On Friday, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) convenes, and several drug developers — from Roche to smaller development-stage participants such as Pharmasset (Nasdaq: VRUS) — will present data on their lead compounds for treating hepatitis C.
It’s an exciting time to follow the hepatitis C treatment space, since there have never before been so many new compounds in development for the disease. With so many compounds to sift through, we can look at the leading drug candidates that may play a role in changing how the hepatitis C virus (HCV) will be attacked.
The leaders
Right now, most patients infected with the genotype 1 HCV — the most common subtype of HCV in North America and Europe — are treated with an interferon-based therapy consisting of either Schering-Plough’s (NYSE: SGP) PEGINTRON or Roche’s Pegasys.
Only about half of the genotype 1-infected patients who are treated with these standards of care, in combination with ribavirin, achieve a sustained virologic response, meaning they show no signs of HCV in their blood six months following treatment.
Having no signs of HCV at any time during a course of treatment means a patient has undetectable viral loads. When patients achieve undetectable viral loads, it could indicate the possibility of a sustained virologic response and, perhaps, ultimately being cured of the disease.
The future of HCV treatment will almost assuredly consist of a combination of an interferon and an oral antiviral drug. More than a dozen oral antivirals are in various development stages, ranging from Abbott Labs’ (NYSE: ABT) preclinical-stage protease inhibitor to Vertex Pharmaceuticals’ (Nasdaq: VRTX) phase 2 candidate, telaprevir.
Here are the leaders in efficacy and stage of clinical development in the race to become the first oral antiviral hepatitis C treatment on the market.
Drug
Developer
Select Study Results*
Development Phase
HCV Target
R1626
Roche
81% of patients with undetectable viral loads after 4 weeks at optimal dose, in combination with Pegasys in treatment-naive patients.
Completed phase 2a testing.
Nucleoside polymerase inhibitor
R7128
Pharmasset
Up to a mean 2.7 log reduction in viral loads after 14 days of treatment as monotherapy in treatment-experienced patients.
Phase 1 combination therapy testing.
Nucleoside polymerase inhibitor
Telaprevir
Vertex
79% of patients with undetectable viral loads after 12 weeks at optimal doses, in combination with Pegasys in treatment-naive patients in most recent study.
Multiple ongoing phase 2 studies.
Protease inhibitor
HCV-796
ViroPharma (Nasdaq: VPHM)
73% of patients with undetectable viral loads after 12 weeks in combination with PEGINTRON in treatment-naive patients.
Dosing in phase 2 study halted because of adverse events. Patient follow-up continues.
Non-nucleoside polymerase inhibitor
Boceprevir
Schering-Plough
79% of patients with undetectable viral loads at optimal dose after 12 weeks, in combination with PEGINTRON in treatment-naive patients.
Multiple ongoing phase 2 studies.
Protease inhibitor
*Study results in genotype 1 HCV patients and all combination study results include the use of ribavirin.
All the compounds above that have enough data to date show incredible improvements in undetectable viral loads (if the data holds up over longer testing), versus about half of the patients who achieve a sustained virologic response from PEGINTRON or Pegasys therapy alone.
Still, it’s not all gravy for the anti-HCV drugs in the table: Every single compound except the Pharmasset drug (which has not been tested in patients very long) has shown side effects, such as a rash with telaprevir, gastrointestinal problems with boceprevir, neutropenia with R1626, and high liver enzyme levels with HCV-796.
Innovations everywhere
The advent of antiviral compounds isn’t the only innovation under way for treating HCV. There are also drugmakers, including Flamel Technologies and Human Genome Sciences, attempting to develop improved versions of the interferons. Flamel’s drug is in phase 1 testing, and Human Genome Sciences expects phase 3 results from its compound, dubbed albuferon, in 2009.
A more distant future in combating hepatitis C could see the disappearance of the interferons from treatment altogether and the combination use of only antiviral drugs. Roche, Schering-Plough, Abbott, and Gilead Sciences (Nasdaq: GILD) all have the resources to develop antiviral-only combination therapies, similar to what is used to treat HIV. At the AASLD meeting, Schering, Novartis, and Idenix Pharmaceuticals (Nasdaq: IDIX) will present preclinical data on in vitro testing of a polymerase and protease inhibitor in combination treatment without an interferon therapy.
Participants in the upcoming AASLD meeting know that, even though there have been stumbles in 2007 with Idenix’s lead HCV drug valopicitabine, Achillion Pharmaceuticals’ GS 9132, and ViroPharma’s HCV-796, it’s still an unprecedented time in the development of HCV therapies.
April 13th, 2008 at 9:32 am
Phase II Study Shows that Nitazoxanide Significantly Improves Response to Standard of Care in Patients with Chronic Hepatitis C
Data to be Presented at AASLD Meeting
Press Release: November 2, 2007
Romark Laboratories, a privately-owned biotechnology company, today announced results of a randomized phase II clinical trial showing that 79% of interferon-naïve patients with chronic hepatitis C genotype 4 receiving nitazoxanide plus the standard of care had a sustained virologic response (SVR), or undetectable level of virus, 12 weeks following treatment, compared to 43% of patients receiving the standard of care without nitazoxanide. The patients treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care. Interim results from this Phase II clinical trial will be presented on Tuesday November 6 in an oral presentation at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
“Patients treated with nitazoxanide responded earlier and maintained their responses without relapse after receiving only 36 weeks of treatment with peginterferon and ribavirin,” said Dr. Emmet B. Keeffe, Chief of Hepatology at Stanford University School of Medicine. “These data suggest the emergence of a new therapeutic approach for treating hepatitis C. While more study is needed to confirm these results in a broader population of patients, nitazoxanide appears to increase the potency of interferon without increasing toxicity or inducing resistance.”
Study Details
This Phase II randomized, controlled trial was conducted at two centers in Egypt and is part of the company’s STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) clinical development program, which is designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with peginterferon or peginterferon and ribavirin (standard of care) in patients with chronic hepatitis C.
In the trial, 96 treatment-naive patients with chronic hepatitis C genotype 4 were randomized into three groups to receive either 48 weeks of standard of care treatment (n=40), 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon (a dual regimen, n=28), or 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus standard of care treatment (a triple regimen, n=28). An additional 24 interferon-experienced patients were randomized to receive 12 weeks of nitazoxanide followed by either the dual regimen (n=12) or the triple regimen (n=12) for 36 weeks. Patients received 180 microgram injections of pegylated interferon (Pegasys®) once per week; nitazoxanide was administered as one 500 mg tablet twice daily; and ribavirin was administered as 1,000 or 1,200 mg daily according to weight.
Results
At 12 weeks following the end of treatment, naïve patients who received a triple regimen that included standard of care and nitazoxanide showed a significantly higher SVR (HCV RNA
July 13th, 2008 at 8:42 am
hello
dear sir or madam
i m very intersted into knowing more about the product,telaprevir (vx950),if it would cure hepatitis c cirrhosis,if its on the market ,how long do you use it for,and how much does it cost.
thanks a lot
yours sincerly
July 13th, 2008 at 8:42 am
hello
dear sir or madam
i m very intersted into knowing more about the product,telaprevir (vx950),if it would cure hepatitis c cirrhosis,if its on the market ,how long do you use it for,and how much does it cost.
thanks a lot
yours sincerly