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  • Publication number WO2014052931 A1
    Publication type Application
    Application number PCT/US2013/062479
    Publication date Apr 3, 2014
    Filing date Sep 27, 2013
    Priority date Sep 29, 2012
    Also published as US20140094504
    Inventors Cristiana Guiducci, Karen L. Fearon, Franck Barrat
    Applicant Dynavax Technologies Corporation

    Provided herein are human Toll-like receptor (TLR)-inhibitors and methods for use in individuals having an autoimmune disease or an inflammatory disorder. The TLR inhibitors of the present disclosure are polynucleotides comprising an inhibitory motif for one or more of TLR7, TLR8 and TLR9.

    Sentiment: Strong Buy

  • Reply to

    DVAX = $7.00 AT LEAST.

    by strawhatjoe Jul 19, 2014 2:26 PM

    You underestimate. With the rampant sex that's going on everywhere (for example our town has declared Aug 1 as "free sex day"), there will be a resulting tremendous increase in population. Therefore there will be even bigger epidemic than you predict. This will only get MUCH worse! Based on this analysis, DVAX = $70.00 AT LEAST.

  • Reply to

    DVAX = $7.00 AT LEAST.

    by strawhatjoe Jul 19, 2014 2:26 PM

    That's great news black bird.
    Dynavax's HEPLISAV Demonstrates Superior Seroprotection in Diabetics with diabetes mellitus compared to Engerix-B given as three doses over 24 weeks.
    Engerix-B(R) is a registered trademark of GlaxoSmithKline.

    Sentiment: Strong Buy

  • Reply to

    DVAX = $7.00 AT LEAST.

    by strawhatjoe Jul 19, 2014 2:26 PM

    You showed him raven. Way to flex them muscles. If only he had your knowledge, judgment, and expertise. Wait a minute, if he did, he'd be probably broke right now. A big mouth like you doesn't translate into the qualities I just listed. I can tell you know junk when you see it. Good eye raven LOL.

  • APRU is ready to explode. With such a low PPS it could double or trople your money almost instantly.

  • Reply to

    DVAX = $7.00 AT LEAST.

    by strawhatjoe Jul 19, 2014 2:26 PM

    No, mister.
    What he's trying to tell you (that you don't want to listen to) is that HEPLISAV IS NOT PART OF THAT PARTNERSHIP AGREEMENT.

    There never has been any sort of agreement with GSK regarding Heplisav.
    Are you investing here because you believe that there IS some sort of partnership agreement with GSK on Heplisav????
    OOOPS! You missed that one; didn't you?

    Dynavax IS partnered to GSK but on Lupus and a bunch of other junk that they are not now, and may never be working on.

    Do you know who Heplisav's chief competitor would be on the market???
    Oh, that's not awkward at all; now is it?

    Apparently, Beowulf knew something you didn't.........

  • Reply to

    DVAX = $7.00 AT LEAST.

    by strawhatjoe Jul 19, 2014 2:26 PM

    Look on DVAX website. DVAX is partnered with GSK.

  • Can new COO ignite a turnaround at DPSM?

  • Reply to

    FDA next follow up

    by missalli789 Jul 18, 2014 10:00 AM

    DSMB reviews are not done for business purposes.....rather for trial integrity and subject safety purposes.

  • Reply to

    DVAX = $7.00 AT LEAST.

    by strawhatjoe Jul 19, 2014 2:26 PM

    Heplisav is NOT partnered with GSK

  • Reply to

    FDA next follow up

    by missalli789 Jul 18, 2014 10:00 AM

    Dynavax has good information on their website that's not available in the media. I recommend going to the Investors tab and clicking News & Events.

    Sentiment: Hold

  • Reply to

    DVAX = $7.00 AT LEAST.

    by strawhatjoe Jul 19, 2014 2:26 PM

    Dynavax is already partnered with GlaxoSmithKline. Is that not big enough?

  • Reply to

    FDA next follow up

    by missalli789 Jul 18, 2014 10:00 AM

    The full safety dataset will be reviewed periodically by an independent Data and Safety Monitoring Board to ensure the safety of subjects and scientific integrity of the study. The DSMB will perform at least three prespecified reviews.

    DVAX should expect a review sometime around October of 2014.

    Sentiment: Strong Buy

  • Reply to

    FDA next follow up

    by missalli789 Jul 18, 2014 10:00 AM

    If Dynavax had anyone with any business experience in the entire company, there would be an update at least each quarter. Of course they don't so we have to figure it out ourselves.

    Sentiment: Hold

  • Reply to

    New study just came out.

    by strawhatjoe Jul 19, 2014 2:36 PM

    8:26 am ET
    Jul 17, 2014 HEPATITIS C
    Will Gilead’s Hepatitis C Drug Bust State Budgets?
    ARTICLE
    COMMENTS (15)
    ABBVIE
    EXPRESS SCRIPTS
    GILEAD SCIENCES
    HEPATITIS C
    RIBAVRIN
    SOVALDI
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    By ED SILVERMAN



    Will the cost of new hepatitis C treatments bust state budgets?

    A new analysis suggests many states may, in fact, be overwhelmed as they attempt to pay for the Solvaldi medication sold by Gilead Sciences GILD +4.84%, which costs $84,000 for each patient, and several forthcoming treatments that may be priced at a similar level.

    More than 750,000 Americans with chronic hepatitis C receive health care coverage through Medicaid or the prison system. And in its analysis, Express Scripts ESRX +0.61%, the nation’s largest pharmacy benefits manager, consequently projects that states will collectively spend more than $55.2 billion to provide Sovaldi to all comers.

    The largest per capita expense will be paid by Louisiana, where an estimated 18,000 state-funded chronic hepatitis C patients live and the state tab is projected to reach $1.4 billion, or $294 per resident. The other top five states in terms of highest per capita spending will be Delaware at $265; Mississippi at $259; Oklahoma at $223, and Texas at $200, according to the pharmacy benefits manager.

    “Since health care for so many hepatitis C patients is funded by state programs, each citizen will be shouldering the unprecedented cost burden,” says Steve Miller, chief medical officer at Express Scripts, says in a statement. “The unsustainable pricing of this medication has, essentially, become a tax on all Americans.”

    Looked at another way, the report says 13 states, led by Georgia and Louisiana, may spend more on hepatitis C medications than they spent last year on transportation. In other words, states will have to make trade-offs as they attempt to offer treatment to citizens, according to Jeff Myers, who heads Medicaid Health Plans of America, the tr

  • Reply to

    New study just came out.

    by strawhatjoe Jul 19, 2014 2:36 PM

    Great copy and paste job !

  • Home
    Diseases, Conditions, Syndromes
    July 19, 2014



    Hepatitis C cured in co-infected HIV patients






    A multicenter team of researchers report that in a phase III clinical trial, a combination drug therapy cures chronic hepatitis C in the majority of patients co-infected with both HIV and hepatitis C.




    "In many settings, hepatitis C is now a leading cause of death among HIV co-infected patients," says Mark Sulkowski, M.D., medical director of the Johns Hopkins Infectious Disease Center for Viral Hepatitis and professor of medicine at the Johns Hopkins University School of Medicine. Approximately one-third of HIV patients in the United States have hepatitis C, with an estimated 7 million co-infected patients worldwide.

    Because of poor tolerability to the previous standard of treatments for hepatitis C, including injections of interferon-alpha and medications that can have interactions with anti-retroviral medications used to treat HIV, this population of co-infection patients has been considered difficult to treat. Data from this phase III clinical trial were incorporated into the FDA's approval of the new drug, sofosbuvir, last December, so treatment with this all-oral regimen—sofosbuvir and ribavirin—is considered on-label.

    The trial, paid for by the developers of sofosbuvir, Gilead Sciences, is published in the July 23 issue of The Journal of the American Medical Association.

    Researchers and doctors enrolled study participants from the United States and Puerto Rico through 34 academic, private practice and community health centers. In total, doctors administered sofosbuvir and ribavirin to a total of 223 HIV-1 patients chronically co-infected with hepatitis C (genotypes 1, 2 or 3) either for 12 weeks (for treatment-naive patients with genotype 2 or 3) or for 24 weeks (for treatment-naive patents with genotype 1 or treatment-experienced patents with genotype 2 or 3). Twelve weeks after treatment ended, researchers tested patients again for hepatitis C infection to determine if treatment was effective.

    For treatment-naive patients, 76 percent with genotype 1, 88 percent with genotype 2 and 67 percent with genotype 3 were cured. "We've always termed this to be 'sustained virologic response,'" says Sulkowski, "but we now know that means hepatitis C has been cured." Treatment-experienced patients had even better cure rates: 92 percent for patients with genotype 2 and 94 percent for patients with genotype 3. Seven patients discontinued treatment because of adverse events, but there were no observed adverse effects on HIV or its treatment.

    "The likelihood that a patient with chronic, long-standing hepatitis C infection would have spontaneous cure is near zero," says Sulkowski, "so if these patients had not been treated, none would have been cured." Because of this, typically the control group of patients in a clinical trial undergoes the standard-of-care treatment, which for hepatitis C is weekly Interferon injections and twice-daily ribavirin orally. However, neither the investigators nor the potential clinical trial participants were willing to accept a therapy that for HIV co-infected patients had both low efficacy and poor tolerability.

    In addition, says Sulkowski, "Doctors and patients alike recognize the idea that it would be difficult, if not impossible, to randomize clinical trial participants to an injectable treatment (interferon) that's linked to many side effects versus an oral treatment (sofosbuvir plus ribavirin)." For these reasons, the clinical trial, named PHOTON-1, was open-label, nonrandomized and uncontrolled. "The PHOTON-1 study represents the first clinical trial to demonstrate that we can cure hepatitis C in patients with HIV co-infection without the use of interferon," says Sulkowski. "As such, it represents a transformative step in our approach to this therapeutic area."

    Explore further: New drug combo cures toughest cases of hepatitis C, hints to future injection-free therapies

    More information: Paper: DOI: 10.1001/jama.2014.7734
    Editorial: DOI: 10.1001/jama.2014.7734



    Journal reference: Journal of the American Medical Association search and more info website

    Provided by Johns Hopkins University School of Medicine search and more info website


    view popular
    5 /5 (2 votes)











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    Home
    Diseases, Conditions, Syndromes
    July 19, 2014



    Hepatitis C cured in co-infected HIV patients






    A multicenter team of researchers report that in a phase III clinical trial, a combination drug therapy cures chronic hepatitis C in the majority of patients co-infected with both HIV and hepatitis C.




    "In many settings, hepatitis C is now a leading cause of death among HIV co-infected patients," says Mark Sulkowski, M.D., medical director of the Johns Hopkins Infectious Disease Center for Viral Hepatitis and professor of medicine at the Johns Hopkins University School of Medicine. Approximately one-third of HIV patients in the United States have hepatitis C, with an estimated 7 million co-infected patients worldwide.

    Because of poor tolerability to the previous standard of treatments for hepatitis C, including injections of interferon-alpha and medications that can have interactions with anti-retroviral medications used to treat HIV, this population of co-infection patients has been considered difficult to treat. Data from this phase III clinical trial were incorporated into the FDA's approval of the new drug, sofosbuvir, last December, so treatment with this all-oral regimen—sofosbuvir and ribavirin—is considered on-label.

    The trial, paid for by the developers of sofosbuvir, Gilead Sciences, is published in the July 23 issue of The Journal of the American Medical Association.

    Researchers and doctors enrolled study participants from the United States and Puerto Rico through 34 academic, private practice and community health centers. In total, doctors administered sofosbuvir and ribavirin to a total of 223 HIV-1 patients chronically co-infected with hepatitis C (genotypes 1, 2 or 3) either for 12 weeks (for treatment-naive patients with genotype 2 or 3) or for 24 weeks (for treatment-naive patents with genotype 1 or treatment-experienced patents with genotype 2 or 3). Twelve weeks after treatment ended, researchers tested patients again for hepatitis C infection to determine if treatment was effective.

    For treatment-naive patients, 76 percent with genotype 1, 88 percent with genotype 2 and 67 percent with genotype 3 were cured. "We've always termed this to be 'sustained virologic response,'" says Sulkowski, "but we now know that means hepatitis C has been cured." Treatment-experienced patients had even better cure rates: 92 percent for patients with genotype 2 and 94 percent for patients with genotype 3. Seven patients discontinued treatment because of adverse events, but there were no observed adverse effects on HIV or its treatment.

    "The likelihood that a patient with chronic, long-standing hepatitis C infection would have spontaneous cure is near zero," says Sulkowski, "so if these patients had not been treated, none would have been cured." Because of this, typically the control group of patients in a clinical trial undergoes the standard-of-care treatment, which for hepatitis C is weekly Interferon injections and twice-daily ribavirin orally. However, neither the investigators nor the potential clinical trial participants were willing to accept a therapy that for HIV co-infected patients had both low efficacy and poor tolerability.

    In addition, says Sulkowski, "Doctors and patients alike recognize the idea that it would be difficult, if not impossible, to randomize clinical trial participants to an injectable treatment (interferon) that's linked to many side effects versus an oral treatment (sofosbuvir plus ribavirin)." For these reasons, the clinical trial, named PHOTON-1, was open-label, nonrandomized and uncontrolled. "The PHOTON-1 study represents the first clinical trial to demonstrate that we can cure hepatitis C in patients with HIV co-infection without the use of interferon," says Sulkowski. "As such, it represents a transformative step in our approach to this therapeutic area."

    Explore further: New drug combo cures toughest cases of hepatitis C, hints to future injection-free therapies

    More information: Paper: DOI: 10.1001/jama.2014.7734
    Editorial: DOI: 10.1001/jama.2014.7734



    Journal reference: Journal of the American Medical Association search and more info website

    Provided by Johns Hopkins University School of Medicine search and more info website


    view popular
    5 /5 (2 votes)











    Share on Tumblr

    add to favorites email to friend print save as pdf






    Featured

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    Most shared




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    New combination drug therapy proves very effective in Hepatitis C treatments Apr 12, 2014

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    Mark Sulkowski, M.D., medical director of the Johns Hopkins Infectious Disease Center for Viral Hepatitis and professor of medicine at the Johns Hopkins University School of Medicine. Approximately one-third of HIV patients in the United States have hepatitis C, with an estimated 7 million co-infected patients worldwide.

    Because of poor tolerability to the previous standard of treatments for hepatitis C, including injections of interferon-alpha and medications that can have interactions with anti-retroviral medications used to treat HIV, this population of co-infection patients has been considered difficult to treat. Data from this phase III clinical trial were incorporated into the FDA's approval of the new drug, sofosbuvir, last December, so treatment with this all-oral regimen—sofosbuvir and ribavirin—is considered on-label.

    The trial, paid for by the developers of sofosbuvir, Gilead Sciences, is published in the July 23 issue of The Journal of the American Medical Association.

    Researchers and doctors enrolled study participants from the United States and Puerto Rico through 34 academic, private practice and community health centers. In total, doctors administered sofosbuvir and ribavirin to a total of 223 HIV-1 patients chronically co-infected with hepatitis C (genotypes 1, 2 or 3) either for 12 weeks (for treatment-naive patients with genotype 2 or 3) or for 24 weeks (for treatment-naive patents with genotype 1 or treatment-experienced patents with genotype 2 or 3). Twelve weeks after treatment ended, researchers tested patients again for hepatitis C infection to determine if treatment was effective.

    For treatment-naive patie

  • Sorry Dude, but you do not substantiate any of your information.

    Sentiment: Strong Buy

  • Hepatitis is becoming more common disease because of the way it's transmitted. People are having sex now more freely because of societal changes and infidelity among married couples which are spreading rapidly all over the world, mainly because of poverty and the failing institution of marriage. As the population balloons all over the world, poverty will become more prevalent, thus infidelity will only increase . Hence, diseases like hepatitis will spread in epidemic proportions. This will only get worse. We are already running out of medicines to treat diseases. It will not be long before a BIG PHARMA SEE THE POTENTIAL HERE!!!!!!!!

DVAX
1.410.00(0.00%)Jul 22 4:00 PMEDT

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