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gs9620 human studies in san diego
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gs9620 human studies in san diego

they are moving unusually fast, better for us!
afraid of myrcludex or rep9ac?

http://health.ucsd.edu/specialties/gastro/areas-expertise/liver-center/research-clinical-trials/Pages/hepatitis.aspx

GS-US-283-0102: A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynmamics, and Antiviral Activity of GS-9620 in Virologically Suppressed Subjects with Chronic Heptitis B Virus Infection.
Sponsor:  Gilead
Indication: Hepatitis B
Criteria: Requires overnight stays at the CTRI
Phase: 1
Drug: GS-9620 oral small-molecule TLR7-agonist
GS-US-283-0106: A Double-Blind, Randomized, Placebo-Contolled, Single and Multiple-Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmocokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naïve Subjects with Chronic Heptitis B Virus Infection.
Sponsor:  Gilead
Indication: Hepatitis B
Criteria: No previous treatment/requires overnight stays at the CTRI
Phase: 1
Drug: GS-9620 oral

GS-US-283-0110: A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Loss of S Antigen (HBsAg) and Sustained HBV Viral Load Reduction Below the Limit of Quantitation (BLQ) in Gilead-Sponsored Trials of GS-9620 in Subjects with Chronic Hepatits B Infection
Sponsor:  Gilead
Indication: Hepatitis B
Criteria: Failed GS-6920 treatment
Registry study: No drug involved/Data collection only
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http://www.baybio.org/events/details/pharmaceuticals-of-the-future-problems-and-solutions/

May 19, 2012 - Category: Community Events

We have assembled leading scientists from San Francisco Bay Area biotechnology companies who will share their experiences and challenges in transforming an idea for a novel therapeutic into a pharmaceutical that is either market ready or close to ready. You will hear speakers from Amgen, Genentech, Bayer HealthCare, Nektar, Gilead, and Rinat (Pfizer).      


9:00- Welcome

9:15
Alexander Kamb, Ph.D. Senior Vice President of Research,Amgen
“A Stronger Spine: Lessons from an Innovative Bone Drug“

9:45
Stephen K. Doberstein, Ph.D. Senior Vice President, Nektar Therapeutics
“Smart Pharmacology: Putting Active Drugs in the Right Place at the Right Time”

10:20
David Cox M.D., Ph.D. Senior Vice President, Rinat/Pfizer
“Human Genetics, Precision Medicine and Improved Health Outcomes”

10:55- coffee break

11:15
John Murphy, Ph.D. Director, Molecular Biology and Protein Expression, Bayer HealthCare
“Engineering post-translational modifications to improve efficacy of recombinant Factor VIIa”

11:50
Randall Halcomb, Ph.D. Director of Medicinal Chemistry, Gilead Sciences
“Discovery of GS-9620, an oral agonist of Toll-like
receptor 7 for the treatment of chronic hepatitis B and C infection

12:25
Fred deSauvage, Ph.D. Vice-president of Research-Molecular Biology, Genentech
“Development of a Hedgehog Pathway Inhibitor for the treatment of Basal Cell Carcinoma”
Start Date: May 19, 2012. 09:00 AM
End Date: May 19, 2012. 01:00 PM
Location: Genentech Hall, Byers Auditorium
Address: 600 16th St., San Francisco, CA, , United States
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Interesting, thanks. I thought they have already completed Phase I trial for GS-9620, and we are now awaiting news for a Phase 2 trial.
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I think this is the trial Gish was telling me about at my last appointment.  They have a trial for people who are currently taking another Nuc which is good.  Hope I don't get the placebo!
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I don't think the "phase: 1" in the description is the same as in "phase 1 clinical trial" because these trials are on "Subjects with Chronic Heptitis B Virus Infection", not healthy individuals.
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So you are going to join the trial?
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I'm going to see if I can.  But with school, I don't know how well spending the nights at the facility will work out.
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"afraid of myrcludex or rep9ac?"

I don't think Gilead really worries about myrcludex or rep9ac.  I think they develop GS-9620 for hep C market. (They are doing GS-9620 trial on hep C at the same time.)  It just happens to show anti-hep B activity, so hep B is getting a free ride.  Hep C market is where the big money is, because hep C is largely a disease of industrialized countries where Gilead can charge a lot of money for the drug.  Hep B population is mostly in not-so-wealthy asian countries, where the company can't make a big profit.  It's very sad, but that's how big pharmas operate (at least here in US).

Just my cynical opinion.
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I see your point. I have a feeling these are private studies and not open clinical trials, as I have been looking around the website.
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You may be right.  These could be pilot studies before they plunge into real phase 2.
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StephenCastlecrag

we need details about the doses they are going to use as soon as they come available so if imiquimod has any similarity or effect we know how to use it

is the san diego meeting private?
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I don't know.  I will find out more details when Dr. Gish's research lead contacts me to discuss the details.  I will post the information here when I find out.
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It seems Dr Gish is in charge of the trials. They are not running yet, so no details are posed on the website. They are open to the public.

Do keep us posted.
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I just got an email from Dr. Gish.  The intake for these trails will begin at the end of May.
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do you know if int'l trials are planned in 2012 or just this small one in san diego for now?

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i am up to something. i hope this time it works. running against time. should have been a virologist instead. didn't they know you could have everything yet chose this path. why? for what?

come out bellerophon.  
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do you know how is plan to be this trial ?
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The coordinator for this trial has emailed me.  She has added me to their list for intake and will be in contact with me shortly.  I will update when I find out more information.
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Do we know can others that are already on antivirals like Tenofovir can switch to gs9620 or combo with it?

Then the base question is, should someone switch or combo? Or is it too early to tell...?
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no switch, why to switch?

gs9620 is an immune modifier not an antiviral

in these trials they just want to see response at various doses and see if gs9620 can have a better response on antivirals
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What is the latest happy news of GS9620 trial?
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Here is the latest email from the study coordinator:
Thank you for your message. There are still some outstanding administrative and regulatory approvals we are still waiting for to start the study. Then the sponsor of the study, Gilead Sciences, Inc. sends a member of their external monitoring group for what’s called a “Site Initiation Visit” (SIV). At the SIV, the external monitor reviews our facility, speaks with our study staff, reviews information with our pharmacy, and study staff, etc. All these outstanding items could take approximately a month or more to iron out. I am sorry I cannot offer a more definitive timeline, but that is my best estimate.
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Hi,

I have check the latest update for the drug watch at HBV foundation web site which was in 18/6/2012, and I notice that the medicene (GS9620) Not mentioned in the list..!!!

can you explain me the reasons..

Thanks a lot...
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Hi,

I have check the latest update for the drug watch at HBV foundation web site which was in 18/6/2012, and I notice that the medicene (GS9620) Not mentioned in the list..!!!

can you explain me the reasons..

Thanks a lot
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You can be proactive as ask HBF, not stef2011 as he is not responsible for what the foundation decides to include on the list!  I went ahead and emailed HBF and asked them to include GS9620 and a more promising drug in preclinicals called ARC-520 from Arrowhead Research.
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Hi,

Could you please till us  the latest happy news of GS9620 trial?

Thanks a lot..
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Trials are underway in San Diego right now.
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How come they did not notify me! I spoke with dr. Gish he said I am on their list and that they will call me. This is not cool at all!  I have been taking baraclude for six years .  And i really wanted to try this. Damn it,
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sent you a message.  One of the caveats of being in this trial is that you will be ineligible for future trials.  I'd rather save it up for a better trial.
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Thanks   I will email them and discuss everything.
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e-mailed them, and see what the say..

So guys GS9620 is a what? Immune modulator really?
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Well so much for GS9620.. They have turned me down. Even without seeing me :)

Six years fighting Hep B, I have all the records in order. Told them they can do all they want with me. And no go. This *****, really. Only six people they took, and stage two will be in the "distant future"

Stefano, which medication is sold with this compound. Is that Imiqumod or something?
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Yep just checked it is Aldara cream.. Anybody seen these in pill form?
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You should be glad they turned you down.  If you were to participate, you'd be ineligible for any future clinical trials through them. I'd rather be in a Phase II or even better an ARC-520 trial when they start those up.
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DJ, I know it all done with looking out for our best interests.. :)

But, when I spoke with Dr.Gish over the phone I took it I be in this study per our conversation. That is why I did not start Pegasys in spring.

Phase II when this will be? Distant future could mean 2-5 years. Us HepB chronics don't have much time especially when there are substances available today that were better then nucs, and less toxic.. every year we live with this we have a greater chance of developing hcc. Interferon or substance that stimulate it in our body is the best bet so far.

I just wish I was told up front that the study was opened only to treatment naive patients and those that were on Tenofovir. I would not look forward to this study then and just to do pegasys injections and see what it would do for me.

It is just very disappointing being kinda told one thing, make plans for it and  it turned out to be different. :(
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indirect update:

" The Selective TLR-7 Agonist GS-9620 Consistently Induces a Spectrum of In Vitro Immune Responses in Human Peripheral Blood Mononuclear Cells from Male and Female Donors. " - this is the title for a presentation that will came in AASLD in November (no other info available at this moment)
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This is like industry news. We need something more solid then this. All i can say they are moving along way slow of the needed pace.
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hows the result of the trial?? has it improved your immunity?
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