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GS9620
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GS9620

I just had an appointment with Dr. Gish - he said there is yet to be unreleased data from clinical trials showing GS 9620 has been effective, and non-toxic in escalating doses. He said things look very promising.  He also said clinical trials are still ongoing and they've relaxed the inclusion criteria, so others may be able to join (veteranB).

He also mentioned that ARC-520 will be doing first trials in Asia, then phase II trials in the USA.  He mentioned that ARC-520 may come to market sooner than Rep9AC', which he feels is still a long way away from coming to market.
19 Comments Post a Comment
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Avatar_m_tn
Very encouraging news, thanks.
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Avatar_m_tn
Praise to Allah ..
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Avatar_m_tn
Thanks DJ. I will email him.
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Avatar_f_tn
Am i missing something here?
Do we have any data on the clinical performances of these two compds even speculative in terms of success?
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Avatar_m_tn
They are still enrolling people in this trial, need to be HBV DNA Und to qualify.  They are looking to clear the surface antigen with GS9620
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Avatar_f_tn
@djxpress thanks for your response.
I guess to be undetected one has to be on Nuc's or had done intf in the past??
Am i correct?
The compds are designed for people that i currently on Nuc's treatment?
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Avatar_m_tn
this trial is taking nuc naive patients and those on treatment.  Need to be und for 3 months on nucs to be in the treatment arm.
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Avatar_m_tn
what could be expected year for these option to hit market?
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Avatar_m_tn
still in clinical trials - probably released 2017/2018 when Gilead loses Viread patent protection.
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Avatar_m_tn
Have you tried it though?  :)
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Avatar_m_tn
Regarding 2017-2018 statements when these drugs are expected to roll out. Do these companies have an idea for us as to what we should do now? How to live?.

These drugs work now based on what is shown. At least what Replicor has reported. Why not take that data and do clinical testing on this? Testing it on more people that is.

Their treatment approach is right.

So sure it is exciting to hear about 2018. But many of us have forgotten what a normal life feels like. I understand about patents and everything. But there must be a human factor present over profits. And we are not asking to get anything free. But asking for a chance.

That is why I really like to see somebody here from these drug companies that makes decisions to  answer all these questions. as to do they feel right taking that long bringing these drugs to market when there are 300 million sick people?

For me that is a big question. Where humanity in all this is? There has to be a better way then the rules of FDA. And if these rules are amoral and corrupt then why follow them.  300 million sick people are hostages of some strange rules and regulations.

And that is what these large companies are missing. That if they turn their face to us people they can actually make more profits and cut their overhead costs by using these same forums. Getting public funds for treatment trials.

In today's advances in   Medicine clinical trials or product testing can be done at home with monitoring of a  physician. Providing it is not something extreme that even animal studies have failed.

I mean they give interferon treatment at home and chemotherapy with minimal monitoring - and yet they worry about with something as imiquimod.

This imiquimod GS9620 main ingredient i am being told knocks out HPV virus. Very effective against Hep C too. That is what people that worked as biologists that studied viruses report. Information is out there.

And these companies with their financial backing must have a great idea on what it really takes.

And yet we see a slow process   Of these medications reaching the market.

On the safety subject. Is it really safe to take approved NUCs for a long time?

Why people develop.high blood pressure on them? Thyroid and kidney issues. Toxicity that leads to cancers. Why we need to take this? A class of drugs that was developed to slow down the spread if cancer cells. That is why they chose it for HIV to slow it down because it damages every human cell it can enter.

Hbv is much simpler then this with the key being raving up the immune system. And it was known for years.

So only in recent years with public awareness about antivirals (if they even can be called that ) we see a push towards compounds or medical treatments that can help the body clear hbv at greater rate then 2% per year.

So heaving said all this. Please those that watch these forums on behalf of big pharma and doctors that make decisions please take notice. And try to change the way things are done regarding making all this happen  in a better timeframe. 2017-18 is just too long for us.
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Avatar_m_tn
I visit many hepb forums world wide. Some have to read via google translate. And what people write is tremendous frustrations with our situation and the slow drug development process. Some if the reported stories are heart breaking.

So I hope the medical industry as it is called now is aware of this. There has to be a better way to roll out these medications and combo treatments then the standard that is in place today. Especially for grave diseases such as ours. That affects young people.

Most of us dont even live. It does not feel like life. And yet there is a fear of death. And anger that there are better treatments available for which there is no access. There is such a thing as regulation. Trying out Zadaxin that boosts the immune system infection fighting cells is impossible. when the key is the immune system - a.smart and healthy immune system that clears cancers and viruses.

There just needs to be a better way to get this before the patents expire.
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Avatar_m_tn
i think they are planning trials of gs9620 with antiviral experience people. is it not possible they don't have to wait to expire their patent date as they may come with a option of cure with viread+gs9620 combo? like combos in hep c two way profit for gilead. do u know anybody going for these trials?
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Avatar_m_tn
I wanted to get in, University of San Diego is within one hour driving distance. I am still waiting to be called I guess.

p.s. Djexpress here has all the info he is a regular patient/medical student there.

Maybe he can comment on the whole situation :)
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Avatar_m_tn
What would really  be the right thing to do is use Replicor plus GS9620 to clear HBV. Rep9 takes out surface antigen, GS9620 raves up the immune system better then interferon and more tolerable. Because it is our body own interferon, which we will never develop antibodies to like what happens with the use of synthetic peg and alike.

That is why I say guys we need to do something, instead of talking about TDF, ETV, combo etc. We need to push these companies to really release these meds.

If we refuse to take all these drugs that do us no good, we win because their profits blow up. Patient education, awareness about the truth what is going on and why produces results.

We need these medication now.. there is enough money going around to save life of every chronically ill hbv patient..
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Avatar_m_tn
there is another way and that is generic. in india bristol (etv) and roche(peg) has lost patents and generics are available in cheap cost. motivate pple to use generics ,they are equally effective and cheap and enough capable to make these greedy big pharma to loose profts if they are not really innovative.next is tenofovir patent.
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Avatar_m_tn
no doubt on gilead intellectual capabilities,they have given such a potent medicine like tenovir. they have a sound technical understanding of disease. but one thing a want to convey why they want to und hbsag for now because that may be a big challenge and time consuming and due to this medicine will be available  on 2017/18. for the time they can come with gs9620 compund as hbsag reducing ,viral reducing  and immune stimulator agent . get  the approval in less time from fda and then, they can continue addon academic trials to clear hbsag or leave the things to doctrs to experiiment with it whether with nucs ,interferon or any other future agent.
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Avatar_m_tn
http://www.businesswire.com/news/home/20130428005003/en/Transgene-Presents-Promising-Pre-Clinical-Data-TG1050-Treat

April 29, 2013 01:45 AM Eastern Daylight Time
Transgene Presents Promising Pre-Clinical Data on TG1050 to Treat Chronic HBV at EASL 2013

    Initiation of a Phase I study in 2014
    New first in class immunotherapeutic to treat CHB

EASL 2013

STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:

    “This type of approach provides new hope towards the development of a treatment with limited duration either alone or in combination with nucleoside analogues.”

Transgene SA (Paris:TNG) (Euronext Paris: FR0005175080), a biopharmaceutical company that develops targeted immunotherapy products to treat major unmet medical needs in cancer and chronic infectious diseases, announced pre-clinical data obtained with its novel immunotherapeutic, TG1050, to treat chronic hepatitis B infection (CHB). These results were presented in an oral session (Hepatitis B and D Experimental) at this year’s European Association for the Study of the Liver Conference (Amsterdam, Netherlands, April 24-28, 2013).

Philippe Archinard, Chairman and Chief Executive Officer of Transgene, stated: “We are excited that TG1050 was selected for an oral presentation at EASL. We hope that this presentation will trigger interest in the scientific community as well as discussions with potential partners. We expect to start a first-in-human/phase 1 clinical trial in 2014 and we believe that TG1050 is currently the most promising direct active immunotherapeutic in development for the treatment of CHB, an area of unmet medical need and high worldwide prevalence.”

The selection process from 32 promising product candidates of TG1050 was endorsed and approved by different panels of key opinion leaders in the viral hepatitis field. TG1050 is based on a non-replicative Adenovirus 5 vector that encodes three HBV (Hepatitis B Virus) antigens or related domains. The clinical candidate has demonstrated potent immunogenicity in pre-clinical mouse models as well as genetic stability. Immunogenic properties include induction of potent, multi-specific, functional and cross-reactive T cell responses, including both cytokines production (IFNγ/TNFα) and in vivo cytolysis; all important characteristics that have been associated with viral clearance during natural infection.

Today’s presentation provided updated and more recent data that demonstrated the capacity of TG1050 to induce long-lasting HBV-specific memory T cells. Experiments in two murine models based on hepatic expression of the full length HBV genome, a HBV transgenic mouse model (University of Ulm) and a model using a recombinant adenovirus associated virus encoding HBV (AAV-HBV, Institute Pasteur) showed that a single injection of TG1050 had the capacity to educate HBV-specific functional T cells within a tolerant environment without inducing liver inflammation, whilst displaying antiviral activities, which were particularly shown in the AAV model.

“TG1050 is to my knowledge the most comprehensive HBV immunotherapeutic currently under development that will be delivered by a single vector. Viral vectors and adenovirus-based vectors in particular, remain today the most efficient delivery platform when it comes to inducing strong cellular immune responses which play a central role in the control of HBV infection. A strong inverse correlation exists between HBV specific functional T-cells and control/eradication of viremia; immunotherapeutic for the treatment of CHB may provide a significant increased cure rate to the existing antiviral drugs” stated Dr Fabien Zoulim, Medical Director of the Liver Department at the Hospices Civils de Lyon and Scientific Director of the Hepatitis Research Laboratory at INSERM Unit 1052. He added further: “This type of approach provides new hope towards the development of a treatment with limited duration either alone or in combination with nucleoside analogues.”

About TG1050

The novel immunotherapeutic product TG1050 developed by Transgene to treat chronic infection by hepatitis B is based on a recombinant non-replicative human adenovirus serotype 5, expressing multiple specific HBV antigens (Core, Polymerase and Envelope) from genotype D. The product has been designed to prime de novo and/or stimulate functional T cells expected to control the HBV replication and to elicit viral clearance.

According to the World Health Organization’s (“WHO”) estimates, 350 million people are chronic carriers (WHO, 2009) of HBV. Hepatitis B is more common in some parts of the world than others. In China and other parts of Asia, up to 10% of the population is believed to be chronically infected. In addition to the significant burden of disease, CHB is responsible for 1 million deaths each year due to related complications such as liver failure, cirrhosis or hepatocellular carcinoma (liver cancer).

About Transgene

Transgene (NYSE-Euronext: TNG), a member of the Institut Mérieux Group, is a biopharmaceutical company. We create, develop and manufacture targeted immunotherapeutics for the treatment of cancers and infectious diseases. Our products are major technological breakthroughs that use well tolerated viruses to indirectly or directly kill infected or cancerous cells. Our four most advanced products have generated proof of concept data in randomized clinical studies: in lung cancer (TG4010), liver cancer (Pexa-Vec), hepatitis C (TG4040) and HPV-related cervical lesions (TG4001). We have concluded strategic agreements for the development of three of these products: an option agreement with Novartis for the development of TG4010, an in-licensing agreement with US-based Jennerex, Inc. to develop and market Pexa-Vec and a strategic collaboration with EORTC to develop TG4001 in cancer of the oropharynx. We also have a non-exclusive agreement with Sanofi/Genzyme for the future commercial production of our products. Most of our 280 employees are based in Strasbourg, France, and we have operations in Lyon, China and the USA. Additional information about Transgene is available at www.transgene.fr.
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Avatar_m_tn
Oh boy when will this all be available.
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