VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid
I know some people don't like the vx-950 posts. This is really to good not to post.
New data announced today by Vertex Pharmaceuticals Incorporated VRTX show that VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor, dosed in combination with pegylated interferon alfa-2a (Pegasys(R); peg-IFN), achieved a rapid and dramatic reduction in plasma viral RNA levels in patients with chronic genotype 1 HCV infection. In this Phase Ib study, the combination of VX-950 and peg-IFN produced an initial median reduction in plasma HCV RNA of more than 3 log10 in the first two days, followed by continued decline to a median 5.5 log10 reduction in HCV RNA at day 14, which equates to a 300,000- fold reduction in viral levels. The majority of patients (6 of 8) receiving the combination achieved HCV RNA levels below the limit of quantitation (30 IU/mL, as measured by the Roche TaqMan(R) assay) at 14 days, with 4 of 8 patients achieving HCV RNA levels below the limit of detection (10 IU/mL, Roche TaqMan(R)). The antiviral activity of the combination through 14 days was significantly greater than the activity of VX-950 administered as a single agent, and much greater than peg-IFN alone. In addition, VX-950 appeared to be well-tolerated when dosed alone and in combination with peg-IFN in the study. The full data set will be presented at a medical conference later this year.
There is more to this story. Only allowed 1600 Characters. They do go on to say they are looking at only 3 Months for treatment. That has got to be good news.
After watching the stock price rise last week I knew someone had the Europe trial info. Truly amazing News. No I do not own the stock or any stock for that matter. I figured somthing was up with the activity.
maybe I am missing something, but is this not basically the same data that was floating around before? extremely rapid viral load drop? I don't think anything really new has come out yet. It seems to still be Phase 1.
at least the stock talk is left out, ;-]
It does sound extremely hopeful, but until SVR data comes in, none of the new meds have a place in standard tx protocol.I am waiting for Phase III results, in ALL meds on trials, before getting excited.
one person's opinion
The 2-week period was completed quite some time ago. How come no info since them? Rebound? Rapid resistance?
Also on the horizon with much better data from a ongoing phase IIb trial without the thrombocytopenia and neutropenia safety issues VX950 has shown.
Idenix Pharmaceuticals Reports Positive 4-Week Data From A Phase IIb Clinical Trial Evaluating Valopicitabine (NM283) Combined with Pegylated Interferon in Treatment-Naive Hepatitis C Patients
SAN FRANCISCO, Jan 09, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) announced partial 4-week data today from an ongoing phase IIb clinical trial demonstrating that treatment with valopicitabine combined with pegylated interferon resulted in rapid and marked reduction in virus levels in treatment-naïve genotype 1 hepatitis C patients. The mean reduction in virus levels was greater than or equal to 4 log10, or 99.99 percent, after 4 weeks of treatment among patients in the two dose groups that began on Day 1 with 800 mg doses of valopicitabine. This trial is almost fully enrolled, with a target enrollment of 175 patients at more than 20 medical centers in the U.S. These partial data will be presented at the 24th Annual JP Morgan Healthcare Conference on Wednesday, January 11 at 2:00 p.m. (PST).
Just to give everyone a perspective to this news, the L.A. Times reported in October of last year that there were currently over 24 new HCV treatments in developement.
As another added note any new drugs were 3 to 5 years from being FDA approved. Peace
This is new news today. The old news was just with vx-950. This is with peg and vx-950. The Europe trials. If you want to read the whole thing go to http://news.moneycentral.msn.com/ticker/article.asp?Feed=PR&Date=20060109&ID=5400140&Symbol=US:VRTX
I'll pop on my sopbox for just a sec here, then hop off. Thanks for indulging me.
Cuteus: I'm basing my comments from memory. This is combo therapy this time. I belive VX-950 mono-therapy gave about a mean 4.5 L drop in 2 weeks. Combo with INF raised that to 5.5 L, a full log above VX-950 mono - in two weeks. Compare that to SOC where our target is overall 2 log total in 12 weeks.
Andy: "The 2-week period was completed quite some time ago. How come no info since them? Rebound? Rapid resistance?"
<b>NOBODY</b> discloses the data that VRTX does. VRTX was under no obligation to disclose the rebounds they encountered in sub-otimal dosing before - yet they did. In fact, they published patient level detail for every arm of the study. Yet you imply they hide something. Of course, you offer no evidence that they have hidden anything. Just whispers from your secret sources in the pharm industry - well I'll admit, your anti-VRTX bias sure does reek of ties to secret sources in the pharm industry.
"Also on the horizon with much better data from a ongoing phase IIb trial without the thrombocytopenia and neutropenia safety issues VX950 has shown."
Fallacy of the Assumed but Hidden Truth: To assume that a conspiracy is in place to guard a hidden truth which would devastate the conspirators if it got out? This is fallacious as it is not substantiated.
Well, if you call 1 log in 2 weeks 'a little', then yeah, I suppose so. Hey maybe it's the VX-950 threads that are causing my hair to thin?
Andy: Sorry - couldn't make it through your post. FYI, my interest here is watching for a cure for HCV, I don't care about VRTX share price anymore than I do whether gas goes up or down a nickle a gallon. If another PI shows more promise, I'll be more happy.
LMAO! you cut and pasted that from an old VRTX thread! LOL
I remeber the post, and it was from a VRTX long, and is dated, but was quite correct. It was a bottom, and the stock is at a new 52 week high. That isn't an issue.
Don't plagiarize what isn't yours.
I found the post.
Also, the neutropenia and thrombocytopenia you blamed on 950, the release clearly states was in the IFN arm only.
I haven't been in here since I announced my leave, but checked in today because I had a feeling there would be distortions.
Thanks, I think of my friends from here every day, even though I do not wish to be an active discussion participant. I decided against removing my name, and decided to exercise self-restraint from posting on controversial subjects. In the end, none of it matters, only time will tell for sure, and there is no way to change that.
I know you and others have made this point before, but the fact remains that not everyone has the capacity to brush off hurtful words, especially those on treatment often dealing with some very difficult psychological sides. "Sticks and stones can break my bones but names can never hurt me" has been disproven by psychologist after psychologist. Words can hurt and worse they set up a negative environment which yes, can affect one's health.
Regarding your own little "situation", although you're one of those able to "handle" these things, it's a shame that such a thoughtful poster like yourself should be subjected to the harrassment you've been lately. I assume you've notified MH and hopefully action will be taken. All the best.
I was wondering what your post was all about...lOl, talk about coincidences. If everybody leaves or does not stand for an opinion on how to be civilized, then nothing changes. I have taken grief myself from friends here from trying to keep things from escalating into insults and personal attacks. The funny thing is, many feel personally attacked when their opinion is challenged and I don't see how that can be help.
If your mind is still somewhat lucid after 40 something wks, share in, balance comes from many sides. Some might think insults balance the kissy kissy stuff, but hopefully not too many think that.
PS some of it can be morbidly entertaining to some warped minds(sometimes I fall in that category, but aren't we all a tad mischevious sometimes?)
remember that cognitive stuff we discussed a while back? I just typed "kind" for can, in can be. When will it end? I still notice it in many others here, is not your basic; their for there stuff, either.
I look at it much simpler. Insults, personal attacks and derogatory remarks have no place in an internet discussion group, especially one supposedly serving the needs of some very sick people on some very strong drugs.
There is something very wrong going on here and as I've said before, it's an issue for management for deal with. Without proper oversight/moderation, this sort of thing will happen in any internet discussion group where people hide behind their anonymity typing whatever they want into a keyboard.
The fact that you (myself as well) choose to stay in this environment, does not mean that's a good choice for others.
Cuteus"PS some of it can be morbidly entertaining to some warped minds(sometimes I fall in that category, but aren't we all a tad mischevious sometimes?)"
Watching a train wreck can be fun unless you're in that wreck. Right now I'm feeling pretty OK upstairs but it wasn't that long ago that the meds stressed me to the point where toxic conversation was making me sick.
It amazes me that people here -- especially those that have been through treatment -- don't go especially out of their way to tone down discussion in light of who this forum is for.
you think that tastes nasty, I think the stuff from the supermarket is actually stronger. I have been taking it since Oct. (as has my wife) and we never refrigerated it. We are on our second or third bottle too. We were using it in salad, but now use balsamic. I think it doesn't need refrigeration since it is anti-viral and anti-bacterial anyway. I was concerned with issues like that before I started taking it, but could find none in the research I did on the internet and books.
A suggestion for you, based on how my wife takes it, would be to add more water. I drink mine in a 10-12 ounce glass, she takes the some amount in at least twice as much water. Since I am not a big fan of water, it actually tastes good to me.
I think it is helping me, hope you find it the same.
I only caught part of it, I am sure it will be archived. Actually, considering it was short, I think I missed a majority of it. Usually those are archived within several hours or the next day.
hope you are feeling/doing well.
Wow You people really amaze me. Why can't you take the news for what it is. We can all read whatever we want into it. I for one like the fact that there has been good results so far. Maybe it won't pan out. However so far so good, and getting better!
VX-950 + PegIFN Achieves 5.5 Log Drop in HCV RNA After 14 Days
Press release from Vertex
VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid and Dramatic Reduction in Viral Levels in Combination with Pegylated Interferon
-Median 5.5 log10 reduction in HCV RNA achieved in patients receiving VX-950 and peg-IFN in 14-day clinical study-
Cambridge, MA, January 9, 2006- New data announced today by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) show that VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor, dosed in combination with pegylated interferon alfa-2a (Pegasys‚; peg-IFN), achieved a rapid and dramatic reduction in plasma viral RNA levels in patients with chronic genotype 1 HCV infection. In this Phase Ib study, the combination of VX-950 and peg-IFN produced an initial median reduction in plasma HCV RNA of more than 3 log10 in the first two days, followed by continued decline to a median 5.5 log10 reduction in HCV RNA at day 14, which equates to a 300,000-fold reduction in viral levels. The majority of patients (6 of 8) receiving the combination achieved HCV RNA levels below the limit of quantitation (30 IU/mL, as measured by the Roche TaqMan assay) at 14 days, with 4 of 8 patients achieving HCV RNA levels below the limit of detection (10 IU/mL, Roche TaqMan). The antiviral activity of the combination through 14 days was significantly greater than the activity of VX-950 administered as a single agent, and much greater than peg-IFN alone. In addition, VX-950 appeared to be well-tolerated when dosed alone and in combination with peg-IFN in the study. The full data set will be presented at a medical conference later this year.
“These data show that VX-950, in combination with pegylated interferon, produced a very rapid viral response in each of these genotype 1 patients, who are historically the most difficult to treat effectively,” said Henk W. Reesink, MD, Associate Professor of Medicine at Academic Medical Center in Amsterdam, and a lead investigator for the study. “The profound decreases in viral load strongly support the evaluation of VX-950 in combination with pegylated interferon as part of a three-month treatment paradigm to achieve sustained viral responses (SVR) in HCV patients.”
Study Design and Results
The 14-day, randomized, blinded, placebo-controlled Phase Ib study enrolled 20 treatment-naïve patients with genotype 1 HCV, the most prevalent and difficult to treat form of HCV infection. Patients were randomized to receive a new tablet formulation of VX-950 at a dose of 750 mg every eight hours (q8h) in combination with a standard dose of peg-IFN (n=8), the same dose of VX-950 administered alone (n=8), or a standard dose of peg-IFN alone (n=4). The median viral load for all patients at study entry was 6.65 log10 IU/mL HCV RNA (approximately 4.4 million IU/mL). Available interim results indicate:
* A median 5.5 log10 reduction in HCV RNA in patients receiving VX-950 and peg-IFN for 14 days; 6 of 8 patients had viral levels below the limit of quantitation (30 IU/mL) at 14 days, and 4 of 8 also achieved viral levels below the limit of detection (10 IU/mL).
* A median 4.0 log10 reduction in HCV RNA in patients receiving VX-950 alone for 14 days; 1 of 8 patients had viral levels below the limit of detection (10 IU/mL).
* A median 1.0 log10 reduction in HCV RNA in patients receiving peg-IFN alone for 14 days; no patients had viral levels below the limit of quantitation (30 IU/mL) at 14 days.
A preliminary safety review has been conducted that indicates that the treatment was well tolerated. All patients completed dosing and no serious adverse events were reported. All adverse events in the patients receiving VX-950 alone were reported as mild. Typical interferon-related side effects, of mild to moderate severity, were reported in the patients that received peg-IFN along with VX-950 or placebo. Laboratory-related adverse events of neutropenia in one patient and thrombocytopenia in one patient were reported among the patients who received peg-IFN. Neutropenia and thrombocytopenia have previously been reported in patients receiving peg-IFN alone. It is not known if the two patients in whom these events occurred were also receiving VX-950, because the full safety database has not yet been unblinded. A complete safety analysis will be conducted once the study is fully unblinded.
“The data announced today provide further support for VX-950's potential to transform the standard of care in HCV,” said Joshua Boger, Ph.D., Chairman, President and Chief Executive Officer of Vertex. “We look forward to pursuing additional clinical studies in 2006 that will evaluate the ability of VX-950, in combination with pegylated interferon, to achieve sustained viral responses in HCV patients, with a shorter duration of treatment compared to the current standard of care.”
Vertex is conducting a broad Phase II development program designed to establish the safety and antiviral activity of VX-950 in studies of up to three months duration. In the next few months, Vertex expects to initiate a three-month Phase II trial with more than 200 participants that will study VX-950 dosed in combination with peg-IFN, both with and without ribavirin, another standard HCV treatment. This three-month study will include a comparison to the current standard of care in HCV treatment. Additionally, a 12-patient, 28-day Phase II trial of VX-950 plus peg-IFN and ribavirin has now completed enrollment and preliminary data from this study are anticipated in the first quarter. In December 2005, VX-950 received Fast Track designation from the U.S. Food and Drug Administration.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the liver and blood of people with the disease. HCV, a serious public health concern affecting 3.4 million individuals in the United States, is spread primarily through direct contact with the blood of infected people. Though many people with hepatitis C may not experience symptoms nor be aware of their infection, others may have symptoms such as jaundice and fatigue. Hepatitis C significantly increases a person's risk for developing chronic liver disease, cirrhosis, the need for liver transplantation, liver cancer, or death. Current treatments are commonly dosed for six to 12 months and may be associated with significant adverse events.
About VX-950 and Previous Clinical Data
VX-950 is an oral inhibitor of hepatitis C virus protease, an enzyme essential for viral replication. In 2005, Vertex reported results from a 14-day, Phase Ib study of VX-950 dosed as a single agent in genotype 1 HCV patients (mostly treatment-experienced patients). In this prior study, VX-950 displayed potent antiviral activity. After 14 days of dosing, patients in the dose group with the best response (750 mg every 8 hours) achieved a median reduction in HCV RNA of 4.4 log10, a 25,000-fold reduction in viral levels. Adverse events observed in patients receiving VX-950 that were considered possibly related to the drug were mild, and generally similar in frequency to events in patients receiving placebo. The most common adverse events reported in both placebo and VX-950 patients were headache, frequent urination and gastrointestinal symptoms.
Vertex researchers were the first to solve the three-dimensional crystal structure of HCV protease, and have used structural insights to enable the design of small molecule HCV protease inhibitors, including VX-950.
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Safe Harbor Statement
This press release may contain forward-looking statements, including statements that (i) VX-950 has the potential to transform the standard of care in HCV infection; (ii) Vertex will pursue additional clinical studies in 2006, including a three-month Phase II trial with more than 200 patients planned for commencement in the next few months, that will evaluate the ability of VX-950 to achieve sustained viral responses (SVR) in HCV patients; and (iii) Vertex will receive preliminary data from its ongoing 28-day Phase II clinical trial in the first quarter of 2006. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex's actual results to vary materially. These risks and uncertainties include, among other things, the risks that (i) full analysis of the data, or further testing, will not reflect the interim results reported in this press release, or support any or all of the conclusions provided in this press release; and (ii) clinical trials for VX-950 may not proceed as planned due to technical, scientific, or patient enrollment issues, clinical trial results may not be available when expected, or expected regulatory filings may not occur or may be delayed due to adverse clinical or non-clinical trial developments or unanticipated FDA action; and other risks listed under Risk Factors in Vertex's Form 10-K filed with the Securities and Exchange Commission on March 16, 2005.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies, and Pegasys is a registered trademark of Hoffman-La Roche Inc.
To some who claimed they would, take their toys and go home, it was obvious to this writer that when this apparent authority insinuated to be expert in a field, when actually not, as when an authority is invoked, are challenged suddenly morph into some form of a victim. Seems there are very strange rules to this game. Some make statements that are fallacious as they are either a non-sequitur or do not allow for substantiation. This is to claim that one individual is somehow inherently more correct than their opponent. This is loosely related to Origin. This gives an unknown as fact. To refer to a system or abstract as if it were a concrete thing. This can be anthropomorphizing (a type of fiction) when this is not justified.
The Ad Hominem argument from Gooofydad involved an attack on my character as one who made a given argument, or their argument assumes their motivation for a given position. It is also fallacious, because it argues that I am somehow defective and so my comments are defective as well, it also fails to address the points made by the initial person and seeks to deflect attention away from the argument at hand. One can call someone names in many different forums. One can also use all the wishful thinking one wants, but assuming that if certain conditions are met a given outcome will follow, when this has not been substantiated, makes ones argument very weak indeed and in reality is just another form of name calling. Toss in a huge pinch of error of fact, when in fact statements were presented as valid, when logic/science dictates that it is not.
Anyway I am off to feed the Corgis and check on Phillip and Charles. Have a wonderful day here at home and throughout the Commonwealth. May the force be with you.
You see, to me, that makes no sense at all. Firstly, far as I could tell, the "potential" of VX950 is based on the same amount of data as BILN had (with about the same level of effectiveness) before - well, you know what happened. Secondly, why wouldn't VRTX set the study up to maximize their chance of success? i.e., plan for the full 48 weeks and - if the 3-month data are compelling - GREAT - off to the races! But that isn't what they're doing is it? No, no, no...for some hitherto unkown reason, VRTX does not want to go past 3 months. "WHY," I must ask myself - why, why why? Can't make enough pills? Inadequate exposure safety margin? Can't afford the pegIFN? Why, why, why?
Major correction will start right after lunch EST...
Smart money will start selling at 34 1/4
As none of this has anything whatsoever to do with anything really, personally new investigational meds that are in phase one or two trials may be exciting to some, but I highly doubt those who injected some form of interferon or are contemplating some method of accessing interferon and somehow managing to actually get through a round of treatment find this a touch lame. I know I do.
Cuteus: "all I want to see is some balance."
Speaking of balance, too bad CTON was run outa here recently. I know some of you inferred he was thin-skinned, but the fact that some members seem to enjoy agressive debate -- including personal slights, insults and references to people's character and education -- doesn't mean that those that won't go along should victimize themselves by being human pinatas. Yes, it would be nice to see some more balance here -- and at least for now, we've lost one very excellent source in this discussion and that is CTON.
Wow, such great work...What we have here is a poor variant of the strawman argument that is partly proactive. It involves the anticipation of counter arguments and the arguer offers preemptive rejoinders. This has some legitimacy as is, but it becomes fallacious when misused. If the user of this technique states that that he has already disproved a given argument because he disproved a similar argument in their preemptive rejoinder; that argument is a strawman, or in this case, some simple advice...Next time you go fishing, make sure you have the right bait, and some knowledge as to the species of the fish you "think" you may have caught would also be somewhat advisable. Then again, to argue that one's expertise or experience allows one to accurately intuit the correct answer to a question or determine the best course of action. This not disprovable and therefore can not be assessed by science. This is related to magical and wishful thinking.
You're not the first person who has come to that conclusion. I post a lot less myself on controversial issues as well. Others like Rifleman have simply left the discussion group in disgust. In the end, we all suffer because less participation means less information. This is the real problem this discussion group has -- it's not the Calio2's or the Spacecoast's -- it's the disprectful and intimidating manner that many call "debate". BTW did you hear the Vertex webcast this morning? I didn't see it available yet on their website.
You have a point. But I am not sure I like the idea of a moderator in the forum. That can be a little disruptive as well. MH tried to change things last yr by asking if folks would be willing to pay a small membership fee, perhaps to help with the upkeep of the site or maybe to open a monitor position, I don't know. In the end, we got the ads on the right side of the thread.
If it is not a paid position it might become what delphi now is, a system of banning anyone the person does not agree with or personally like. I definetely do not want to be scanned by someone and deemed to be too curt and thus offensive. And it could become that. If it can be done without it becoming axing due to personal likes, I am all for it.
MH has rules posted, if they can be enforced to the T, without subjective involvement, it might work. I just don't know how it can be done.
When someone posts their email address, that post disappears. When someone posts a copywritten article in entirety, that post disappears. Yet, abusive and insulting remarks seem to be tolerated. So, yes, this forum is being monitored but I just don't get the priorities.
If you're going to provide a forum for sick people on strong meds you owe those participating more than Terms of Service, you owe them the enforcement of those terms.
Don't know how many discussion groups you have been a part of besides this one, but an unmoderated discussion group is not the norm. Yes, a forum can be overly and unfairly moderated, but the alternative is what you see here. In the end, most people will end up playing by the rules if the rules are truly enforced. And if that means some of us have to curb our sharp-edge, it's a small sacrifice to make for the better good of the whole.
"don't go especially out of their way to tone down discussion in light of who this forum is for."
that is essentially one of the problems, inferring from personal wants and needs what this forum is supposed to be and who it is supposed to be for.
Many feel that the forum is for people with HCV and nothing more, that it is for patients only, for people treating, for those looking for information, or comfort, empathy, encouragement, for those looking to help others somehow with their experience, and on and on.
WHO is the forum for? For all of the above, and more. To state that this forum should only be for folks in tx, is re writing its misssion:
"Med Help International Public Areas are for the exchange of information and support ONLY."
and we had a long thread not too long ago on what support was to those commenting.
Who said this forum is ONLY for people on treatment?
Having said that, right above where I'm posting it says "This form is for patient-to-patient Comments only and is generally not monitored by the forum staff).
So, if this place isn't ONLY for people treating, thinking about treating, or have previously treated -- at the very least people under treatment are a very important part of what this forum is all about and I would think that anyone with any sensitivity would acknowledge that in the manner how they post.
agreed. We all have been bothered by the manner we were addressed at some point, sometimes with reason.
Ultimately, it is up to us how to react to it. In my case, my reaction was related to the tone of the post. It included anything from apathy to angry words, but TG, I did not call anyone an ignoramus or things like that. I guess even on Riba, I knew there was a limit.
Sometimes it is up to us to curb an extreme reaction and sometimes the offender needs to be dealt with. I don't get the priorities sometimes either.
I hope a solution is on sight, besides leaving things up to the HOnors system.
thanks for clarifying your position.
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