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Patient Heart Failure leads Bristol-Myers to Suspend Hepatitis C Drug Study

By Calliope, Aug 3, 2012 | Updated: Aug 24, 2012 | | |
  1. Calliope
    See post 6 for story reporting study cancelled

    The drugmaker Bristol-Myers Squibb said it would suspend a midstage study of a potential hepatitis C treatment after at least one patient experienced heart failure.

    The company is examining all patients in the study because it has not determined the cause of the heart failure or whether it was tied to the potential treatment.

    “We are working in close collaboration with clinical trial investigators and health authorities to ensure the appropriate steps are being taken to protect patient safety,” a spokeswoman, Sonia Choi, said Thursday.

    It announced the suspension on Wednesday and on Thursday, stock in Bristol-Myers, which is based in New York, fell $3.05 or 8.6 percent, to $32.55 a share.

    The drug, labeled BMS-986094, is one of two main potential hepatitis C treatments from Bristol-Myers that investors are focused on, a Bernstein analyst, Dr. Tim Anderson, said in a research note.

    Dr. Anderson said it seemed likely that BMS-986094 would also move to late-stage testing next year, but its prospects were now uncertain. The condition of the patient whose heart failed was not disclosed.

    Bristol-Myers acquired BMS-986094 and some other potential treatments as part of a $2.5 billion acquisition of a drug developer, Inhibitex, this year.

    Published: August 2, 2012



  1. catseye
    oh this is not good news :(
    BMS-986094 (was INX 189) is from the new class of Nucleotide polymerase inhibitors, which have been showing quite a bit of promise for HCV treatment.
    Rumours were flying about preclinical toxicity with this particular drug - very worrying.
  2. Calliope
    Press release from Bristol-Myers

    August 01, 2012 08:37 PM Eastern Daylight Time
    Bristol-Myers Squibb Suspends Administration of Study Drug in Clinical Trial of Investigational NS5B Nucleotide for the Treatment of Hepatitis C

    Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Company has suspended study drug administration in an ongoing Phase II study of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor in development for the treatment of hepatitis C. This voluntary action was taken to protect patient safety based on the emergence of a serious safety issue. The cause of the safety issue and any potential relationship to study drug are unknown at this time.

    With patient safety as the priority, the Company is undertaking an immediate assessment of all patients in the study and following an evaluation of the patient data, will take appropriate actions.

  3. TheBigBadWolf
    NO this really ain't good news.

    Even if the death of a proband must not be connected to the test program, It will mean a break in the study and therefore a longer time to wait for those in need of a better treatment than the ones used today.
    Lets hope for a positve outcome,- and that this study wasn't put up in vain.

  4. godztear
    People die from heart failure all the time. There must be something to spook the researchers out of continuing the study.
  5. Calliope
    Bristol-Myers Ends a Hepatitis C Project

    NYTimes Aug. 23, 2012

    Bristol-Myers Squibb said Thursday that it was discontinuing development of a hepatitis C drug that it had acquired in a $2.5 billion deal, after nine patients in a clinical trial had to be hospitalized and one of them died.

    The company suspended testing of the drug on Aug. 1, after one patient in a midstage clinical trial experienced heart failure. At that time, however, there was still some question of whether the drug, known as BMS-986094, had caused the problem.

    But Thursday evening, the company said that initial patient had died and that eight other patients also had to be hospitalized. Two of them remained hospitalized.

    “While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the company has determined that it is in the best interest of patients to halt development of BMS-986094,” the company said in a statement.

    The scrapping of the drug is a big setback for Bristol-Myers in the heated race to develop a combination of pills to treat hepatitis C, a viral infection that can cause liver scarring and liver cancer.
    Current treatment now involves up to a year of weekly injections with alpha interferon, which causes severe side effects. The hope is that combinations of pills that work by different mechanisms could eradicate hepatitis C without the need for interferon. So companies are scrambling to assemble the components of such an all-oral regimen.

    Bristol-Myers paid $2.5 billion in January to acquire Inhibitex, which was developing the drug that became known as BMS-986094. Bristol-Myers hoped to combine that drug with daclatasvir, another hepatitis C drug that it is continuing to test in clinical trials.

    One question is whether the troubles with BMS-986094 will extend to other drugs in its class, known as nucleotide polymerase inhibitors.

    Last week, Idenix Pharmaceuticals said the Food and Drug Administration placed a hold on a trial of its nucleotide polymerase inhibitor, IDX184, because of the heart failure case in the Bristol-Myers trial. Idenix said it had not seen any cardiac toxicity with its drug.

    Gilead Sciences also has a drug in that class that it obtained by acquiring Pharmasset for $11 billion, though that drug, GS-7977, is somewhat different chemically.


  6. TheBigBadWolf

    Another hope less for those who have the virus and can't have it removed and to those who will acquire forms (genotypes) of the virus where interferone is only little helpful.

    Lets hope for newer sustances with other properties,- but for once and all:

    Live safe, don't get the virus!

    And if you got it,- don't spread it, it's so fucking easy,-
    use rubbers and your own works,- and wear gloves when giving first aid!

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