GI-5005 Trial

[Upbeat]

Anyone doing this trial?   I went to the UMC for my yearly appointment.  I discussed the trial of vx-960 and vx222 that I wasn't able to get into because my platelet count was a little low.  They said they were running the GI-5005 trial. GI-5005 is a  molecular immunogen.  GlobeImmune's Hepatitis C Therapeutic Vaccine, GI-5005, Improves EVR Rates To 94 Percent In Phase 2 Clinical Trial
Heres the strange part.  I may not get into this study because of my good CC genotype from the IL28b test results.
I don't know that for sure but it looks like they had 100% ERVR with the TT gene which is the worse genotype for the interferon based treatment.  Go Figure.  Thats the group the trial is targeting.

[uncledudeness]

I am scheduled to go for the screening this week. it'll prolly be next week tho, the way these snails move at the clinical test kitchen here....my Hepa told  me that to get in, i have to be TT I think. I'll know more when i go for the screening. let's stay in touch, should we both get in the trial we can compare notes.

my platelets are low too, in addition to my high alt/alt values. stage 3/4 here. G 1A

[Cory255]

More informative data on IL28b genetic variations and ancestry.  

http://www.med.upenn.edu/gastro/documents/GeneticVarianceofIL28bandspontaneousclearanceofhepc.pdf

[Cory255]

PHARMACOGENOMIC ANALYSIS REVEALS IMPROVED VIROLOGIC RESPONSE IN ALL IL-28B GENOTYPES IN NAÏVE GENOTYPE 1 CHRONIC HCV PATIENTS TREATED WITH GI-5005 THERAPEUTIC VACCINE PLUS PEG-IFN/RIBAVIRIN

Conclusions: Pharmacogenomic analyses can provide valuable insights into therapeutic trial results. Triple therapy improved ETR regardless of IL-28B genotype; delivering more CC and CT RVRs and more CC and CT slow responders. The effect of GI-5005 on SVR is greatest in patients with the poorest prognosis genotype (TT). IL-28B genotyping suggests that the GI-5005 therapeutic vaccine augments response in those with unfavorable IL-28B types.

http://www.kenes.com/easl2010/Posters/Abstract1068.htm

[Cory255]

Your Welcome.  The GI-5005 is universal.  There is so much research going on w/ the IL28 testing it's not even funny.  This link has at least 10 study write ups.  I did not know there were that many studies being done on the IL28.  

http://www.kenes.com/easl2010/Posters/Session-P03-12.htm

[Upbeat]

Thanks for the link. Very informative.  It appears that GI-5005 works with the CC as well as the TT genotypes,  Really good news for the TT'S.  The IL28B genotyping is all the trial researchers are talking about.  This is such a great breakthrough it really helps the treatment decisions for the TT group as it appears that interferon does not work well at all with this genotype.  

[Cory255]

Here's the study w/ the GI-5005 (very small sample size) that had a 100% SVR in the TT allele group.  The sample size was very small-(5).  I'd imagine they will continue to do more research with this.   It's phase 2 study trial results.  The GI-5005 appears to help people with the TT allele.  

http://www.marketwire.com/press-release/GlobeImmunes-Hepatitis-C-Product-Candidate-Improves-End-Treatment-Response-All-IL-28-1169068.htm

Also take a look at this link, it shows how triple therapy w/ GI-5005 improved svr rates.  

http://www.globeimmune.com/filebase/McHutchison_EASL_2010_-_IL28.pdf