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therapeutic vaccine decreases fibrosis - early trials

What follows is an extract from a press relese by Innogenetics
The full release can be found at

http://www.innogenetics.be/site/newspressrecent.asp?id=126

Seems like some good news to me - but don't get too excited as these things don't always work out


Innogenetics today announced the 3-year histology data of its ongoing phase 2a study in hepatitis C (HCV) patients, which started in early 2001. After 4 courses of HCV E1-based therapeutic vaccine injections given over a 3-year period in 23 patients, liver fibrosis on average showed significant improvement compared to baseline.


The key finding that has now emerged is a regression (improvement) of liver fibrosis averaging minus 0.43 points (95% confidence interval [-0.82, -0.05]) on the Ishak fibrosis scale. This result constitutes a significant decrease (p = 0.044) from baseline. No less than 87% (20/23) of the patients either improved (10/23) or remained stable (10/23) in their Ishak liver fibrosis score. This group of patients (mean age at entry 53 years, HCV genotype 1, with active liver disease) were, for the most part, non-responders to previous interferon-based therapy. Such patients would be expected to show a marked progression in liver fibrosis of about + 0.60 to about + 0.99 points on average...
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Avatar universal
I have followed the vaccine injections, but have not heard much about it lately. This is good news. I hope the vaccine works out and is avalible soon.
I would like to be in the clinical trials and recieving the vaccine injections.

<b>mikeymike2 thanks for the heads up.</B>


                        TonyZ
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Avatar universal
that's great news! i wish it was available for those of us who need to stop progression now. it sounds like this first of trials will be completed in 2005. i wonder what they must do after that to get it on the market? anyone know?
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Sorry to bust in on this thread but I wanted to tell everyone that I just got my 6 month all clear!!!!!!!!!  For those who don't know me, I WAS genotype 1B, had it for over 30 years, VL around 1,000,000, mild damage, and asymptomatic.  I did 48 weeks of PegIntron and Riba, along with Neupogen and Procrit from week 9 to the end.  I've been feeling great for the past couple of months and now even greater!!!!!
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Congratulations sweetie !  What a great feeling that must be !
Someday I hope to be able to say the same. I wish you all the best, and please continue to post. I'm always interested in what you have to say. Stay well :)
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Wonderful news, Galen!  Best wishes for continued good health and much happiness!

Susan
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That is wonderful and I am so happy for you!  Just to hear the sweet words of svr at 6 months must make you feel great!  That is so encouraging also for all of us 1's on clearing this mean old virus right out!!
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Thank you for sharing your wonderful news.  I am genotype 1b.
You have demonstrated that there is hope.  Continued recovery is my wish for you.  God bless.... Edgar
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This is wonderful news!  I am so happy for you.  You deserve the great news and renewed health!  caruu
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Galen: YYYEEEAAAAHHH!!!!


Mickey, Thank you, that kind of info gives us old cirrhosis sufferers hope also !!!!!!  


                   JONI
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Avatar universal
DING-**** THE DRAGONS DEAD!!! 95% OR BETTER NOW BABY!!! THATS THE KINDA NEWS WE LIKE TO HEAR!! ANOTHER ONE BITES THE DUST!!!
I am Sooooo happy for you. You studied, and learned, and fought your way through.....to THIS end. Ain't it GREAT??? What a ride eh? You're gonna make it now sweetie.
Keep in touch and holler at me at the 1 year mark. Then tell me when our dinner date is.......bring your sisters.
hahahahahaha
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Avatar universal
galen: great news - congratulations on becoming an official SVR! I wish you all the best and many thanks for everything you've contributed to this forum.

mickeymike: thanks for the interesting link. Looks like taking the drug amounts to taking injections of E1, one of the virus' two envelope proteins. I wonder what's known about sides at this stage? Taking something that  boosts specific immunity to HCV would seem to have lighter overall impact on the body than  general-purpose immune stimulators like ifn/riba.
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Wonderful news, real happy for you.  I'm a 1b guy with 5 shots left and I hope to be following in your footsteps!
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Oh, Galen, that's just the best news!  I'm so happy for you. It's good to hear you're feeling great, too!
ambush :)
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Avatar universal
Galan....this is great news!  Feel like a new women, hum.  I'm sure you've gone back to work....business must be booming since you have more energy now, and are able to get out there and advertise a little more, hum.

But tell me this Indiana and Galan......is alcohol out of the question forever for you guys?

I'm doing okay, don't have any aches or pains; I just feel a little stiffness in my liver area.  Doc wants me to take an xray which isn't scheduled until 4/19.  3 Months post I was still clear, but time will only tell.   Hi, MAJ Neni.   Val.
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:)  I'm so pleased to hear your results.  I  have appreciated all your support that you have given me since i first posted here last summer. As you might recall, I am also a 1 b
..........Deb
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Great news and good luck with the rest of your "LONG LIFE"- you deserve it- you helped out alot of people tremendously on this forum when they were in real need of advice and a good friend.Can you really believe it's over- wasn't that a hell of a journey. Well at least we can say one thing for sure- we are certainly "Experts" on HCV now. See Ya Around -- Harley Dude
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That's awesome news! I am so glad you posted. I was wondering how you were doing. I can't seem to get my strength back. I slept for three days already this week and seem to need between 10 and 15 hours of sleep a day. My doctor said I should be over all tx symptoms by now (4 months post tx) so I am looking for a new doctor.
Congratulations!
Barb
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Congratulations girl.  You have done it.  That ole virus never had a chance.  I am happy for you sooooo much, and you give us all hope.

By the way, I also have some news.  As you remember, I am a 1a with an initial very high viral load.  I started my Pegasys combo treatment on 1/16/04.  Last week, I went in to my doctor for 8 week tests on 3/15/04.

After 8 weeks of the drugs, I too am undetectable.  I still have 38 shots left, but this should be a breeze now.

Recent studies I have read suggest that if a geno 1 treats for 32 to 36 weeks post clearance, their SVR percentage shoudl be 80 - 90%.  So, my chances are much improved now!
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Mikey: Thanks for the encouraging information.  It's great to see the research moving forward on this terrible virus.

Galen:  I'm very happy for you.  Since I'm also a 1b, the success of your tx is a big encouragement.  I know you lost your special kitty recently.  That is a sadness I also share since we lost our cat, Keetz.  She was our first family cat and we'll miss her.  Pets have a special way of helping us when things get tough, don't they.  My little eskie dog was there with me when I was in severe pain for months.  I keep telling her she's a blessing from God and I mean it.

Wasn't going to log on tonight, but I'm glad I did.  God Bless, Dave
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Minttwist.....it seems that every time we try to talk about alcohol and hcv, Whatever the reason, it ends up in a fight. So if you really want my thoughts on this, send me an e-mail at ***@****   I will respond. I really don't want to ruin this splendid thread.

Itr.....There is a lot of current data that says that you now have an "excellent" chance of killing The Dragon. You and I have looked at this for you for a LONG time. I am Sooooo happy that this is working so well for you now. It won't be easy.....but it WILL be worth it. I will be here ...and there... for you. You CAN do this!
Best of luck as you go through the gauntlet. We are always here for you........

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Avatar universal
You go, Galen.  Terrific news.  We really ought to get a bigger party going for some of us dragonslayers this year.  Any badgers in FL?

Val, nice to catch your note.  I hope you feel better soon, and that life throws fewer spit-balls at you.

I'm feeling pretty good now, 2 months after tx.  My skin has recovered (exc. for seasonal trouble; Elidel rules); my hair is still thin, and it seems to be a dust-magnet.  Blood counts are improving slower than we thought, so I'm using up my leftover Neupogen with the Friday Night brigade.  I'm also having some joint-stuff; want to follow up on my low + RA factor.
There's an RA study going on here, I'll see if I qualify.  My brain is working, except for the memory; and I have good energy until I suddenly hit empty.  My appetite is sooooo good.  
I finished Undetectable on Jan.23, after my 48 weeks. (1b/stage 1/grade 2, high VL to start.)  I'm still negotiating for the 3-month PCR...
This whole tx business is so mental, and waiting - at every stage - is... well... you know.

I've been having computer problems, but I usually still read a couple of times a week.  Greetings, folks.  I hope we keep it nice here.
Majneni
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Avatar universal
Congrats! You have helped me and so many others here and as a 1b hope to follow in your footsteps.

dh bill
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Galen-
<B>WHOOOOPPPPIEEEE!!</B>  
That's the best news I've heard all week!  Another 1-B bites the dust!

Is-this-real,
Really happy to hear that you've cleared at 8 weeks. Keep up the good work!

Best to all you hep warriors out there.

newb
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That's really excellent news, looks like you kicked that ol' dragon's butt for good, really gives the rest of us 1b-ers hope!!!!!!
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