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.
Indication: Hepatitis B
Criteria: Requires overnight stays at the CTRI
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.
Indication: Hepatitis B
Criteria: No previous treatment/requires overnight stays at the CTRI
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
Indication: Hepatitis B
Criteria: Failed GS-6920 treatment
Registry study: No drug involved/Data collection only
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).
Alexander Kamb, Ph.D. Senior Vice President of Research,Amgen
“A Stronger Spine: Lessons from an Innovative Bone Drug“
Stephen K. Doberstein, Ph.D. Senior Vice President, Nektar Therapeutics
“Smart Pharmacology: Putting Active Drugs in the Right Place at the Right Time”
David Cox M.D., Ph.D. Senior Vice President, Rinat/Pfizer
“Human Genetics, Precision Medicine and Improved Health Outcomes”
10:55- coffee break
John Murphy, Ph.D. Director, Molecular Biology and Protein Expression, Bayer HealthCare
“Engineering post-translational modifications to improve efficacy of recombinant Factor VIIa”
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
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
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).
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.
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.
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,
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?
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.
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. :(
" 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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