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Avatar universal

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
37 Responses
Avatar universal
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
Avatar universal
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.
Avatar universal
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!
Avatar universal
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.
Avatar universal
So you are going to join the trial?
Avatar universal
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.
Avatar universal
"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.
Avatar universal
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.
Avatar universal
You may be right.  These could be pilot studies before they plunge into real phase 2.
Avatar universal

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?
Avatar universal
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.
Avatar universal
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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