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Thread: Approved?

  1. #21
    Good article, Rainman.

    I have no idea what this line is doing in the article:

    Although the FDA would not comment on Geron's application, President Bush objects to most research with embryonic stem cells, which come from discarded embryos. Moreover, his administration has become intrigued with recent studies showing skin cells can be manipulated to have embryonic-like properties without harming an embryo.


    No one ever became unsuccessful by helping others out

  2. #22
    Senior Member Jeremy's Avatar
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    One big step for Geron
    Therapy that enabled paralyzed rats to walk ready for test on humans, stem-cell firm says.
    By Steve Johnson
    Mercury News
    Article Launched: 02/24/2008 01:39:43 AM PST
    http://www.siliconvalley.com/ci_8351062

    Using human embryonic stem cells, the Menlo Park company has developed a therapy that enables paralyzed rats to walk and that it claims shows no dangerous side effects in experiments with about 2,000 animals.

    Others also are studying such cells for medical uses, including Stanford University scientists, who last week said they had used them to help stroke-disabled lab rats walk better. But none are as close to seeking permission for human tests as Geron, whose treatment is for spinal injuries.

    For its application requesting regulatory approval from the U.S. Food and Drug Administration, the public company has gathered 25,000 pages of data - far more than normal for such requests, Geron Chief Executive Dr. Thomas Okarma said. He told analysts recently that Geron would submit it to the FDA during the first part of this year. But he declined to reveal the actual filing date, he said, "to minimize any kind of pressure on the agency."

    Yet Geron's bid isn't certain.

    Although the FDA would not comment on Geron's application, President Bush objects to most research with embryonic stem cells, which come from discarded embryos. Moreover, his administration has become intrigued with recent studies showing skin cells can be manipulated to have embryonic-like properties without harming an embryo.

    In addition, although Geron says it has found nothing unsafe about its treatment, some scientists fear embryonic stem cells might cause tumors or other health
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    problems.

    Geron isn't alone in its quest.

    Los Angeles-based Advanced Cell Technology also expects to get FDA approval this year to test people with an eye treatment made from human embryonic stem cells.

    Nonetheless, Okarma said he is confident he'll be allowed to do the human study.

    He and other scientists say the skin-cell technique has technical problems. And he claims no other firm can beat him to the punch.

    "They're not even close," he said. "All these companies are Geron wannabes. . . . We are the pioneers of this and we will reap all of the fruits of that pioneering work."

    More than 250,000 people in this country have spinal injuries and about 11,000 new cases are reported in the United States each year, according to federal data. For now, most of those suffering paralysis have little hope of regaining their physical functions, said Marcie Roth, executive director of the National Spinal Cord Injury Association in Maryland.

    "Our hats are off to companies like Geron," Roth said.

    Even if Geron gets to try its cells on people, it could take years for the treatment to be approved for widespread use, said Graig Suvannavejh, an analyst with UBS Investment Research, who doesn't own Geron stock.

    However, Ren Benjamin, a Rodman & Renshaw analyst who also owns no Geron stock, said getting the OK for the study could mean a quick payday for Geron, because "investors may get excited and buy shares of the company."

    That could be a big boost to Geron, which has consistently lost money since going into business in 1992. It has no products on the market for patients, although it has several in the works.

    The company is developing drugs for various types of cancer and HIV. It's also considering using human embryonic stem cells to help people suffering from heart attacks, osteoporosis and liver disease, among other ailments.

    Yet Geron's revolutionary spinal treatment, which it began researching in 1995 with investors' funding, has generated the most media attention. That's largely due to a breakthrough Geron reported in 2005 when a study it financed showed the treatment could help paralyzed rats walk.

    Embryonic cells can turn into any type of tissue in the body, which is why many scientists think they may have a myriad of medical uses. For the rat study, the cells were coaxed into developing into oligodendrocytes. Those are cells that help nerve fibers replace myelin, a fatty substance that provides insulation, which is important for motor function.

    When a spine is damaged, myelin often is stripped off. That can disrupt the body's ability to transmit sensory signals - similar to the way an electrical cord shorts out when its insulation is peeled away - resulting in paralysis.

    Okarma said the FDA required his company to go to extraordinary lengths to prove the treatment won't harm people. Given the study's unprecedented nature, that is appropriate, said Alan Trounson, president of the California Institute for Regenerative Medicine, which also finances human embryonic stem-cell research.

    "Walking forward purposefully and carefully in this area is what we should be doing," Trounson said.

    Many human embryonic stem-cell colonies scientists have been studying are bathed in mouse skin cells, which provide nutrients but also can transmit viruses or other harmful substances to people. So Geron had to create a way to make such colonies without using mouse cells.

    In addition, the FDA required Geron to prove that hundreds of rats injected with the cells could remain free of tumors and other toxic side effects for nine months to a year. The company successfully did that, Okarma said, but it was hugely labor intensive.

    Under anesthesia, the rats were given injuries much more severe than a paralyzed person normally would experience. That left the animals incapable of regaining bodily functions - even with the treatment. So Geron's researchers had to manually empty each rodents' bladder three times a day for the entire period to keep the rats' kidneys from failing.

    Given the sensitivity of the topic and the amount of data Geron has gathered, it could take the FDA months to render a decision. That might enable Advanced Cell Technology, which had been well behind Geron in readying its treatment for human tests, to narrow the gap.

    Advanced Cell, which has an office in Alameda, has used human embryonic stem cells to grow retinal pigmented epithelial cells, which it hopes to turn into a treatment for eye diseases such as retinitis pigmentosa and age-related macular degeneration.

    It's chief executive, William Caldwell, said he hopes to ask the FDA within months to begin testing the treatment in people. But he said if Okarma is the first to start a human study that's OK, because "I'm one of his greatest fans."

    Not everyone is so charitable. Noting that Geron has been saying for several years that it hoped to soon ask the FDA for permission to do the study, some critics have accused the company of raising false hopes. But Okarma is undeterred.

    "There will be a lot of surprised people, not only that we'll do it but that the agency approved it," he said. "We know we'll be the first."

  3. #23
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    Quote Originally Posted by Tufelhunden
    I sometimes wonder about this myself. Economists are already stigmatized as being evil, LOL.
    Lol, but good thing you are on the alert, hopefully we will hear something soon.

    And good article TheRainman. 25,000 pages of data?

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