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Oxygen Biotherapeutics, AŞ Message Board

  • john_lee_20032003 john_lee_20032003 Dec 20, 2013 6:02 PM Flag

    Does any one know the answer to this? I emailed investor relations but no answer back from them.

    If Abbott Labs did a study of 1,327 patients and showed Levosimendan failed to show any efficacy, why do a Phase 3 enrolling just 760 patients or about half?

    Dear Investor Relations,

    I am a recent investor as of yesterday when after a summary press release the stock ran up to briefly to $5.85 but now closed at 4.74 today when it was just $4.22 the day before. After doing some research to figure out why there is such a large swing in prices (one reason I found is the company has just 10.5 million shares outstanding but over 6 million
    shares traded yesterday and only 1.5 million today), I noticed something very odd:

    The main reason the stock has moved up dramatically from $1.36 on October 1st was because of recent news that Levosimendan will undergo Phase 3 clinical trials with Duke University enrolling 760 patients. But from online research, I see many articles below from 2005 that Abbott Laboratories already did a study of 1,327 patients and it failed to meet endpoints. That is, it did not show any statistically significant survival rates from placebo or competing drug, dobutamine. So, why is this new drug Phase 3 clinical trial any different and what is the benefit if Abbott Labs abandoned the drug in 2007?

    Thank you for your assistance to understand this matter.

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    • wchurch1@sbcglobal.net wchurch1 Dec 20, 2013 6:32 PM Flag

      I’ve already answered this question before and I’m sure you read it but, here it is again. Levosimendan is prescribed for short term use and administered prior to and during open heart surgery. In other words short term usage. This is how it is used in all countries where it is approved. Abbott was experimenting with it for long term usage, long term meaning for a period up to six months after surgery. While Levosiendan does a great job improving heart function a few days or ever a couple of weeks, the body becomes used to it over longer periods of time and it becomes less effective. Abbott Labs was not interested in it for short term usage, only long term. When it didn’t produce the long term results Abbott was looking for Abbott decided to discontinue testing.

      • 4 Replies to wchurch1
      • wchurch1@sbcglobal.net wchurch1 Dec 20, 2013 7:44 PM Flag

        Many believe study you refer to is flawed. That was the reason behind the meta study done at Duke University. By the way a meta study studies the studies. In this case Duke studied the data from all levosimendan studies. The Duke study showed that levosimendan could improve the outcome for heart patients. This is why Duke is willing head up the trials.
        Dobutamine is the drug currently given in the US to people about to undergo heart surgery. Dobutamine however is hard on the body especially the kidneys. Hart patients who receive dobutamine often end up having kidney failure resulting in have to go on dialysis. Obviously this is an unwanted side effect. Levosimendan is far easier on the body and there are no problems with kidney failure. That's it's big advantage.

      • Do you realize the comments by doctors about Levosimendan going back since 2005?
        ______________________________________________________
        The study, SURVIVE, compared Simdax, also known as levosimendan, with an older treatment called dobutamine. The goal of the trial was to show that Simdax reduced mortality by 25% compared with dobutamine, which some doctors believe may actually have a negative effect on how long patients live, at the end of six months.

        Simdax, which is given in the hospital when patients are extremely sick, never reduced mortality by a large enough margin compared with dobutamine to be sure the results weren’t due to chance, but there was a consistent trend toward a benefit. At five days, mortality in the levosimendan group was reduced by 27%. After two weeks, that figure had fallen to 14%; then, at one month, was down to 13%. At six months, when the study ended, mortality in the group was reduced by 6.4%.

        Some doctors feel that dobutamine, the drug to which Simdax was compared, might have ill effects. Earlier this year, New York cardiologist Jonathan Sackner-Bernstein and Keith Aaronson from the University of Michigan stoked controversy when they argued in a pair of scientific papers that Natrecor, a heart failure drug from Johnson & Johnson , might increase death or damage the kidneys.

        There was hope that Simdax would fill the void. But Sackner-Bernstein says that the data seem to support the view that drugs that help acute heart failure symptoms in the short term can do harm in the long term. He says that he believes well-informed patients would prefer doctors look to identify an alternative to Simdax, dobutamine, or Natrecor.

      • So, Levosimendan is not very safe as the doctors found out:

        “Would a short-term improvement in symptoms versus standard therapy be worth an increased risk of dying?” Aaronson asked. “Certainly, I’d want to be sure that my patient was very well informed about the risks and benefits and wanted to accept the tradeoff before I’d prescribe levosimendan.”
        ____
        Acute heart failure results in more than 3 million hospitalizations a year. It has proven very difficult to get new treatments. Some doctors feel that dobutamine, the drug to which Simdax was compared, might have ill effects. Earlier this year, New York cardiologist Jonathan Sackner-Bernstein and Keith Aaronson from the University of Michigan stoked controversy when they argued in a pair of scientific papers that Natrecor, a heart failure drug from Johnson & Johnson , might increase death or damage the kidneys.

        There was hope that Simdax would fill the void. But Sackner-Bernstein says that the data seem to support the view that drugs that help acute heart failure symptoms in the short term can do harm in the long term. He says that he believes well-informed patients would prefer doctors look to identify an alternative to Simdax, dobutamine, or Natrecor.

        Keith Aaronson of the University of Michigan, who co-authored two studies that were critical of Natrecor, from Johnson & Johnson, said that Symdax, or levosimendan, seemed safer than other therapies that are sometimes used to help patients hearts pump better and relieve symptoms, but not as safe as standard therapy.

        “Would a short-term improvement in symptoms versus standard therapy be worth an increased risk of dying?” Aaronson asked. “Certainly, I’d want to be sure that my patient was very well informed about the risks and benefits and wanted to accept the tradeoff before I’d prescribe levosimendan.”

      • SURVIVE is the second disappointment for Simdax in a week–and the third for Abbott. On Monday, the Milton Packer, a cardiologist at the University of Texas, Southwestern, presented data from a 600 patient trial showing that 33% more patients who received Simdax saw their symptoms improve compared to placebo. But 45 patients died in the Simdax group, compared to 35 on placebo. Packer pointed out that if the results are pooled with previous studies, Simdax appears to have no effect on survival.

    • They can't answer you as it opens up a can of worms. It will certainly fail. That is why Abbott Labs let the drug die after 7 years of testing. They cut their losses realizing it is not commercially viable. The only thing you can say it is safe drug, but doesn't do anything. But 4-5 years of more testing gives the executives of the 12 person company fat salaries that no one else would pay them that kind of money.

 
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