VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid

[Upbeat]

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.

[Upbeat]

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.

                                                     Ron

[NYgirl]

Let's all pray that this one finally pans out.  So many disappointments that eventually they HAVE to come up with something better than the current tx and it has to follow all the way through!

As a non-naive person it would not benefit me at this time but for those it would....GO BABY GO!  

GO GO GO!

[cuteus]

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

[andyarundel]

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.

http://tinyurl.com/ak9qz
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).

[cougareyes]

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

[cuteus]

thanks for balancing the act,Andy, there are least two people here on that drug, one of them non responder and is now clear and doing very well. all I want to see is some balance. maybe is just me.

[Upbeat]

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

                                                        Ron

[GoofyDad]

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."

No kidding? Please post references.

[cuteus]

sounds right to me. your memory is holding. I just like to see true balance.  
So the IFN helped a little? looks like combo therapy without the "benefit" of riba. Still, too soon to tell.

I'll try not to pull my hair again next time a vx thread is started, which should be in about 48 hrs. ;-}
TY

[andyarundel]

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.

Your comment

[cuteus]

"I do predict that this stock will go either up, down or remain the same"
lol, I can predict that too!
the rest, I can't touch it! It is still floating over my head...

[GoofyDad]

cuteus: So the IFN helped a little?

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.  

[couldn't think of a nickname]

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.
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=7077370&tid=vrtx&sid=7077370&mid=11107
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.

I am out, be careful believing what is posted.

[jmjm530]

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.

-- Jim

[cuteus]

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.
be well

[jmjm530]

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.

-- Jim

[FlGuy]

Took your advice and started the daily ACV. They sure make a good fruit taste bad.  Oh well, need the extra water anyway. BTW, the label doesn't say,  but if unpasteurized does it require refrigeration?

[jmjm530]

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.

-- Jim

[couldn't think of a nickname]

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.

[andyarundel]

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.

[andyarundel]

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.

[GoofyDad]

Hey glad you dropped in. Nice to see you. Check out the VX thread from fri or sat, for a few more real chuckles. It's not to be missed.

Don't be a stranger.

[couldn't think of a nickname]

Thanks, but I do want to maintain my silence, and I didn't even really lurk here until today. Reader beware.

[jmjm530]

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.

-- Jim