Aa
New to group
Hello,I have hep c 1a and live in Texas. I have a chance to join a study of a new drug called GI 5005 by Globalimmune inc. It would be standard treatment plus this drug. Is there anyone out there who has any info on this drug? The good news is that it would be free. Thanks ,I have enjoyed reading these post,I am sure you all will be a great support group.
Hi, I am in Texas,not sure which one yet but I'll let you know when I find out. Wish we had your healthcare here!
hardrock: What state are you in?
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Well, Canada isn't the 53rd (54th?) State just YET....lol :) How many States do you have now anyway? I forget.
So you have a shot at a protease inhibitor trial? Does it happen to be the VX-950, the telaprevir? The Phase III for naive Genotype 1? If yes, that would be superb.
I'm tolerating the sx well so far....maybe it'll last...maybe it won't ... but I'm not waiting for the hammer to fall, just living. It'll fall when and if it falls.
Thanks for your thoughts.. I wish you lots of good luck too! :)
Trish
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Well, Canada isn't the 53rd (54th?) State just YET....lol :) How many States do you have now anyway? I forget.
So you have a shot at a protease inhibitor trial? Does it happen to be the VX-950, the telaprevir? The Phase III for naive Genotype 1? If yes, that would be superb.
I'm tolerating the sx well so far....maybe it'll last...maybe it won't ... but I'm not waiting for the hammer to fall, just living. It'll fall when and if it falls.
Thanks for your thoughts.. I wish you lots of good luck too! :)
Trish
I am glad to hear you are tollerating the tx so well.Thanks for the advice,I am going to wait for a different study after talking to the Dr. today.The Gi5005 is a study of a vacine and the next one will be a protease inhibutor.What state are you in?Wish you lots of good luck!
I am one week into tx. Honestly...I have no side effects whatsoever so far, other than a half day of fatigue day after my first day. It wore off by dinner hour and if I wasn't taking a mittfull of pills each day, I wouldn't know I was on tx. I'll enjoy that while it lasts. Tomorrow is my second injection.
It's a good study I'm in. It gets pretty good reviews on this forum. The drug has been fast tracked by the FDA so that means it shows good promise as well. So...we shall see. Doesn't mean I will get the drug during this trial ... but means I at least have a shot at getting it. I'll find out at the end.
Which reminds me ... since there are only two arms in your trial, ask if it's blinded or double-blinded. I can't remember from reading your info. Blinded means you won't know which arm you are in. Double-blinded means neither you nor the research team will know. That wouldn't stop me from going in a trial, it's just good information to have.
It's a good study I'm in. It gets pretty good reviews on this forum. The drug has been fast tracked by the FDA so that means it shows good promise as well. So...we shall see. Doesn't mean I will get the drug during this trial ... but means I at least have a shot at getting it. I'll find out at the end.
Which reminds me ... since there are only two arms in your trial, ask if it's blinded or double-blinded. I can't remember from reading your info. Blinded means you won't know which arm you are in. Double-blinded means neither you nor the research team will know. That wouldn't stop me from going in a trial, it's just good information to have.
If you are going in today, ask about the other two trials and if they tell you they are not an option for you, then you know. If they say yes, then you can consider your overall choices. It's also possible that another location in your area is trialling the other two drugs but not your own doctor's location. Up to you how much you want to pursue all this stuff, I'm throwing that out there for you to consider and then you can decide what is good for you.
I'm in the R1626 Phase II trial.
Good luck to you, hardrock.
Trish
I'm in the R1626 Phase II trial.
Good luck to you, hardrock.
Trish
I have had a biopsy and it was at stage 2 and the viral load was at 1.3 mil. I will ask if the ribo is weight based,going in today. What type of trial are you in? Thanks for caring.
The documents for your trial don't say what the dosages for SOC are. I would ask what the ribavirin dosage is and ask if it's weight-based. I am in a trial myself right now but if the ribavirin dosage wasn't weight-based, I wouldn't have gone in it.
I'm wondering if you've had a biopsy and what the results were? I'm also wondering what your viral load is...do you know this?
I'm wondering if you've had a biopsy and what the results were? I'm also wondering what your viral load is...do you know this?
GlobeImmune Announces Presentation of Results from a Randomized Phase 1b Study of the GI-5005 Tarmogen in Patients with Chronic Hepatitis C Infection
LOUISVILLE, CO - November 6, 2007 - GlobeImmune, Inc. today announced results from the additional higher dose cohorts from the Company's randomized, placebo-controlled Phase 1b clinical trial evaluating the safety, immunogenicity, and initial efficacy of GI-5005 in patients with chronic hepatitis C infection. The data were presented today at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). In the Phase 1b study thus far, GI-5005 has demonstrated:
1. A favorable safety profile with the dose escalation to the highest planned dose without dose limiting toxicity. Safety findings were generally limited to transient local injection site reactions and transient mild constitutional complaints.
2. Strong trends for a dose dependent response in the percent of patients that normalize their ALT (a marker of liver damage) compared with placebo, ranging from no normalizations in the placebo group up to 50% of the patients in the highest dose group (40YU).
3. Viral load reductions (nadir) in six treated patients ranging from -0.75 log10 to -1.4 log10. Viral load reductions were achieved with only 12 weeks of GI-5005 monotherapy with no concurrent anti-viral therapy.
4. Biologic / immune activity by converting patients from an immune response profile associated with chronic infection to one similar to patients who clear the virus naturally during the acute phase as measured by ELISpot assay.
5. No placebo patients had near log10 reductions of viral load or demonstrated an immune response by ELISpot assay.
"These results indicate that a short course of GI-5005 alone is capable of generating an HCV specific immune response that is associated with improved liver inflammation and clearance of infected hepatic cells. We find this particularly encouraging since these patients were not treated with concurrent anti- viral therapy; we expect that an immune-based therapy, such as GI-5005, would complement current standard of care or future anti-virals," said David Apelian, M.D., Ph.D., Chief Medical Officer of GlobeImmune. "A Phase 2 trial comparing GI-5005 plus pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin alone is now being initiated at 50 centers in the United States, EU, and India. Long-term GI-5005 salvage therapy will also be examined in this trial in patients who fail to achieve an early virologic response (EVR) or do not tolerate treatment in the pegylated interferon/ribavirin arm."
About GI-5005
GI-5005 is GlobeImmune's lead infectious disease product from its proprietary Tarmogen active immunotherapy platform for the treatment of chronic hepatitis C infection. GI-5005 is whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets. The mechanism of action for GI-5005 (i.e. immune elimination of infected hepatic cells) may work synergistically in combination with the current or emerging standard of care, which directly inhibits viral replication, to more effectively eradicate hepatitis C virus from the liver. Additionally, this mechanism of action may offer an option for interferon-intolerant or interferon-contraindicated patients as a long-term monotherapy. A randomized Phase 2 study evaluating GI-5005 plus standard of care (pegylated interferon plus ribavirin) versus standard of care alone is planned to begin in the fourth quarter of 2007.
LOUISVILLE, CO - November 6, 2007 - GlobeImmune, Inc. today announced results from the additional higher dose cohorts from the Company's randomized, placebo-controlled Phase 1b clinical trial evaluating the safety, immunogenicity, and initial efficacy of GI-5005 in patients with chronic hepatitis C infection. The data were presented today at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). In the Phase 1b study thus far, GI-5005 has demonstrated:
1. A favorable safety profile with the dose escalation to the highest planned dose without dose limiting toxicity. Safety findings were generally limited to transient local injection site reactions and transient mild constitutional complaints.
2. Strong trends for a dose dependent response in the percent of patients that normalize their ALT (a marker of liver damage) compared with placebo, ranging from no normalizations in the placebo group up to 50% of the patients in the highest dose group (40YU).
3. Viral load reductions (nadir) in six treated patients ranging from -0.75 log10 to -1.4 log10. Viral load reductions were achieved with only 12 weeks of GI-5005 monotherapy with no concurrent anti-viral therapy.
4. Biologic / immune activity by converting patients from an immune response profile associated with chronic infection to one similar to patients who clear the virus naturally during the acute phase as measured by ELISpot assay.
5. No placebo patients had near log10 reductions of viral load or demonstrated an immune response by ELISpot assay.
"These results indicate that a short course of GI-5005 alone is capable of generating an HCV specific immune response that is associated with improved liver inflammation and clearance of infected hepatic cells. We find this particularly encouraging since these patients were not treated with concurrent anti- viral therapy; we expect that an immune-based therapy, such as GI-5005, would complement current standard of care or future anti-virals," said David Apelian, M.D., Ph.D., Chief Medical Officer of GlobeImmune. "A Phase 2 trial comparing GI-5005 plus pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin alone is now being initiated at 50 centers in the United States, EU, and India. Long-term GI-5005 salvage therapy will also be examined in this trial in patients who fail to achieve an early virologic response (EVR) or do not tolerate treatment in the pegylated interferon/ribavirin arm."
About GI-5005
GI-5005 is GlobeImmune's lead infectious disease product from its proprietary Tarmogen active immunotherapy platform for the treatment of chronic hepatitis C infection. GI-5005 is whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets. The mechanism of action for GI-5005 (i.e. immune elimination of infected hepatic cells) may work synergistically in combination with the current or emerging standard of care, which directly inhibits viral replication, to more effectively eradicate hepatitis C virus from the liver. Additionally, this mechanism of action may offer an option for interferon-intolerant or interferon-contraindicated patients as a long-term monotherapy. A randomized Phase 2 study evaluating GI-5005 plus standard of care (pegylated interferon plus ribavirin) versus standard of care alone is planned to begin in the fourth quarter of 2007.
I have no idea how much investigation you've done into trials in general. If you don't mind the reading, here is a link that explains about trial phases and trials in general and lists ALL the drugs currently in trial for HCV. Too much information, but you can wade through what matters to you. Or skip it if none of this is relevant. :)
http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html
Your trial in particular :
http://clinicaltrials.gov/ct2/show/NCT00606086?term=GI+5005&rank=1
Comments: A form of therapeutic vaccine that is believed to stimulate the immune system to help fight HCV.
AASLD 2007: A Phase 1b double-blinded, placebo controlled, dose-escalating, multi-center trial evaluating the safety, immunogenicity, and efficacy of GI-5005 found that 11% of patients receiving GI-5005 had viral load reductions from -0.75 to 1.4 log 10 and dose response for ALT normalization reaching 50% in the group receiving the highest dose (40 YU). GI-5005 was well tolerated with no dose limiting toxicities. A Phase 2b trial is being initiated comparing the triple therapy of GI5005, pegylated interferon, and ribavirin to the dual therapy of pegylated interferon and ribavirin.
On December 19th, GlobeImmune announced the initiation of a phase II study expected to enrol 120 patients who will receive Tarmogen in combination with pegylated interferon plus ribavirin and compare the triple to regular standard of care (peg with ribavirin). (December 28, 2007)
As for choosing a drug trial, there are two other trials either recruiting now or will be soon that you should also look into. Both of these show great promise.
Currently recruiting Phase II R1626:
http://clinicaltrials.gov/ct2/show/NCT00517439?term=NCT00517439&rank=1
R1626 is recruiting in three locations in Texas - if you click on the Locations in the above link, you can see if any of them are close to you. While it says recruiting, the recruitment phase for this trial is closed and trial has begun in some locations so you'd have to check fast.
Upcoming Phase III VX-950 for treatment naive Genotype 1 (March 2008?):
http://clinicaltrials.gov/ct2/show/NCT00627926?term=vx-950&rank=11
I would at least consider these in your decision making.
If you decide against these two trials or they are not open to you, your trial looks like a good bet.
http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html
Your trial in particular :
http://clinicaltrials.gov/ct2/show/NCT00606086?term=GI+5005&rank=1
Comments: A form of therapeutic vaccine that is believed to stimulate the immune system to help fight HCV.
AASLD 2007: A Phase 1b double-blinded, placebo controlled, dose-escalating, multi-center trial evaluating the safety, immunogenicity, and efficacy of GI-5005 found that 11% of patients receiving GI-5005 had viral load reductions from -0.75 to 1.4 log 10 and dose response for ALT normalization reaching 50% in the group receiving the highest dose (40 YU). GI-5005 was well tolerated with no dose limiting toxicities. A Phase 2b trial is being initiated comparing the triple therapy of GI5005, pegylated interferon, and ribavirin to the dual therapy of pegylated interferon and ribavirin.
On December 19th, GlobeImmune announced the initiation of a phase II study expected to enrol 120 patients who will receive Tarmogen in combination with pegylated interferon plus ribavirin and compare the triple to regular standard of care (peg with ribavirin). (December 28, 2007)
As for choosing a drug trial, there are two other trials either recruiting now or will be soon that you should also look into. Both of these show great promise.
Currently recruiting Phase II R1626:
http://clinicaltrials.gov/ct2/show/NCT00517439?term=NCT00517439&rank=1
R1626 is recruiting in three locations in Texas - if you click on the Locations in the above link, you can see if any of them are close to you. While it says recruiting, the recruitment phase for this trial is closed and trial has begun in some locations so you'd have to check fast.
Upcoming Phase III VX-950 for treatment naive Genotype 1 (March 2008?):
http://clinicaltrials.gov/ct2/show/NCT00627926?term=vx-950&rank=11
I would at least consider these in your decision making.
If you decide against these two trials or they are not open to you, your trial looks like a good bet.
GlobeImmune is a biopharmaceutical company pioneering the discovery, development and manufacturing of potent, targeted molecular immunotherapies called Tarmogens for the treatment of infectious diseases and cancer.
Tarmogens (Targeted Molecular Immunogens) are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein targets that stimulate the immune system against diseased cells. The whole heat-killed yeast, with the antigen expressed inside, is the product that is administered to the patient. Tarmogens program the cytotoxic T cells (a.k.a. killer T cells) in the patient's immune system to eliminate diseased cells containing the antigen(s). GlobeImmune's patented Tarmogen platform has a number of advantages over current approaches because Tarmogens generate a potent T cell response, are not neutralized by the host immune system upon repeated administration, do not require a custom vaccine approach and are simple to manufacture.
The Company's lead product , GI-5005 a Tarmogen for the treatment of chronic hepatitis C infection has completed a placebo-controlled, dose-escalation Phase 1b clinical trial. A randomized, placebo controlled Phase 2 trial in combination with standard of care will begin in the second half of 2007. GI-4000, a Tarmogen for the treatment of various mutated Ras-mediated cancers, is in a randomized, placebo-controlled, multi-center Phase 2 trial for the treatment of patients with resectable pancreas cancer in combination with adjuvant gemcitabine.
http://www.globeimmune.com/
Tarmogens (Targeted Molecular Immunogens) are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein targets that stimulate the immune system against diseased cells. The whole heat-killed yeast, with the antigen expressed inside, is the product that is administered to the patient. Tarmogens program the cytotoxic T cells (a.k.a. killer T cells) in the patient's immune system to eliminate diseased cells containing the antigen(s). GlobeImmune's patented Tarmogen platform has a number of advantages over current approaches because Tarmogens generate a potent T cell response, are not neutralized by the host immune system upon repeated administration, do not require a custom vaccine approach and are simple to manufacture.
The Company's lead product , GI-5005 a Tarmogen for the treatment of chronic hepatitis C infection has completed a placebo-controlled, dose-escalation Phase 1b clinical trial. A randomized, placebo controlled Phase 2 trial in combination with standard of care will begin in the second half of 2007. GI-4000, a Tarmogen for the treatment of various mutated Ras-mediated cancers, is in a randomized, placebo-controlled, multi-center Phase 2 trial for the treatment of patients with resectable pancreas cancer in combination with adjuvant gemcitabine.
http://www.globeimmune.com/
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