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Thread: Geron will be ready to test a stem cell-based therapy for spinal cord injury in human subjects by 20

  1. #1

    Geron will be ready to test a stem cell-based therapy for spinal cord injury in human subjects by 20

    http://www.shns.com/shns/g_index2.cf...ROP71-11-04-04



    Stem cell initiative a boost for California firms

    By BERNADETTE TANSEY
    San Francisco Chronicle
    04-NOV-04

    Passage of the $3 billion stem cell research initiative, Proposition 71, could help California repeat one of the most celebrated chapters in its business history if one of its most eminent supporters is right.

    By making the state an international hub of stem cell research, California could establish the same early dominance over business development in the new field that it did in the 1970s, when genetic engineering breakthroughs by state academic researchers spawned the first generation of biotechnology firms like Genentech and Chiron.

    "I think this is just as broad a platform as recombinant DNA," said Stanford stem cell researcher Dr. Irving Weissman.

    The Prop. 71 victory is a shot in the arm for California firms like Geron Corp. in Menlo Park, Calif., which has a range of stem cell research programs.

    "We started this field; we dominate it," said Geron Chief Executive Officer Thomas Okarma, who likes the firm's odds to score a state grant. Okarma said Geron will be ready to test a stem cell-based therapy for spinal cord injury in human subjects by 2006.

    Share prices for Geron and another San Francisco Bay Area firm, StemCells Inc. of Palo Alto, Calif., had been rising in the weeks leading up to the election on prospects that John Kerry would quadruple federal stem cell funding if elected.

    But with Bush's victory, both stocks plunged, despite the passage of Prop. 71. The Bush administration is expected to maintain restrictions that were imposed on federal funding of the research because many of Bush's conservative supporters object to the destruction of human embryos to create stem cell lines. Geron shares were down 12 percent and StemCells' lost nearly 24 percent.

    Stem cells are the versatile, undifferentiated cells found in a human embryo when it has grown from a fertilized egg into a multicellular ball. Scientists have learned how to coax stem cells to develop into specialized cells such as neurons or cells that produce insulin _ creating the possibility of therapies for nerve injuries, diabetes and other maladies.

    Stem cell companies and academic scientists are already straining like greyhounds at the starting gate to apply for a share of roughly $300 million that the state will shower on stem cell projects annually for 10 years. Only labs or firms based in California will qualify. The research money will come from a state bond issue that will cost a total of $6 billion to pay off.

    But the long-sought disease cures and business boom dangled before voters as potential benefits of Prop. 71 could be years in coming, industry experts say.

    The California initiative breaks a funding logjam created by the Bush administration's restrictions on federal grants for stem cell work. But Prop. 71 won't eliminate other barriers that may continue to slow the progress of businesses based on stem cell techniques. Those obstacles include tangles over patent rights and the reluctance of venture capitalists to invest in such early stage research.

    Prop. 71 might benefit Geron with grant money, Okarma said, as well as support academic researchers who could collaborate with the firm. In addition, many other companies that develop stem cell products with a boost from Prop. 71 money will end up paying royalties to Geron, he said. The firm not only holds licenses to groundbreaking work on stem cell isolation done at the University of Wisconsin, but has also patented further techniques, he said.

    "Anyone wanting to get into this field would need to take broad licenses from us," Okarma said.

    The thicket of patent rights already staked out by Geron and other firms, however, could become a powerful deterrent to new entries into the field by venture financiers, said Ropes & Gray attorney Matthew Vincent, an expert in stem cell patents.

    "It's a minefield out there," Vincent said. Venture investors would need to carefully assess whether profits from a potential product would be substantially eroded by royalty payments, or even whether patent holders could keep the product off the market. Inventors are not required to grant licenses to their patented techniques, and may not if another firm's product competes with their own, he said.

    A greater hindrance to venture firm investment in stem cell companies is the fact that none are close enough to marketing a product that would hold out a near-term payoff to investors, said Lutz Giebel, a partner at Schroder Ventures Life Sciences.

    Venture firms that would have taken a flier on a mere concept in the heady early days of the biotechnology industry in the 1970s are now putting their money into companies that have already taken a promising therapy as far as late-stage clinical trials in humans. Vast uncertainties still exist about crucial steps toward a marketable stem cell product, including the standards the Food and Drug Administration would impose to approve therapies of such an entirely new type, Giebel said. For the same reasons, large drug and biotech firms will hold back from acquiring or forming joint ventures with stem cell firms, he said.



    (Distributed by Scripps-McClatchy Western Service, http://www.shns.com.)


    SCRIPPS HOWARD NEWS SERVICE
    Scripps Media Center 1090

  2. #2
    Senior Member Schmeky's Avatar
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    Okarma said Geron will be ready to test a stem cell-based therapy for spinal cord injury in human subjects by 2006.
    It was originally the 1st quarter of 2005.

  3. #3
    yea this looks good i cannot wait. I've been waited for 22 years for something, 2 more years is okay.

  4. #4
    Senior Member Schmeky's Avatar
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    Manouli,

    Sorry, but nothing here for chronics. This is an acute only trial.

  5. #5
    Schmeky, As far as I know this is for chronics. I wrote to the company, and as soon they reply I'll show you the answer.good luck to all of us.

  6. #6
    Senior Member Schmeky's Avatar
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    manouli,

    Nope, I have info that states it is for acutes only.

    Nearly all SCI research is aimed at acutes for financial reasons, it has been discussed on this site many times.

    Besides clinical trials take a MINIMUM of 8 years and can be as long as 14 years or more, with good with funding before you can benefit.

    Yes, Geron has made great strides, but don't go to sleep at night counting on being in an acute trial if you're chronic.

  7. #7
    Schmeky, oh boy! By the time I'll be an old lady! I am praying for a miracle. With all the research that is going on something will come on soon, at list I believe that or I want to believe, lol thans.

  8. #8
    Senior Member Jeff's Avatar
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    Geron is developing oligodendrocyte precursors that should help remyelinate the damaged cord after injury. If you're thinking of regeneration or neuron replacement... I don't think those are on Geron's roadmap just yet. It's still a nice advance but just won't produce the massive regeneration so many of us seek.

    From the Geron website:

    We have derived special types of neural cells called oligodendrocyte progenitors from hESCs and have begun testing them in animal models to determine whether they can restore normal neural function. In our collaboration with researchers at the University of California, Irvine, we have shown proof-of-concept in spinal cord-injured rats which showed significant functional improvement after receiving transplants of hESC-derived oligodendrocyte progenitors.
    http://www.geron.com/showpage.asp?code=prodstsp

    ~See you at the SCIWire-used-to-be-paralyzed Reunion ~

  9. #9
    Here what they wrote:


    Thank you for your interest in Geron Corporation.



    We are developing cell-based therapeutics for several diseases based on differentiated cells derived from hESCs, including neural cells for spinal cord injury and Parkinson's disease, cardiomyocytes for heart disease, pancreatic islet ß cells for diabetes, osteoblasts for osteoporosis, chondrocytes for osteoarthritis, and hematopoietic cells for blood diseases and to prevent immune rejection of the other cell types. We have developed proprietary methods to grow, maintain and scale up undifferentiated hESCs and differentiate them into therapeutically relevant cells. We are now testing six different therapeutic cell types in animal models. In three of these cell types, we have preliminary results indicating efficacy as evidenced by functional recovery of the treated animals. After completion of these studies, we expect to begin one or more Phase I clinical trials, most likely including treatment for acute spinal cord injury.

  10. #10
    Senior Member Jeff's Avatar
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    manouli - please don't be fooled by "neural cells." These "neural cells" for spinal cord injury are oligodendrocyte progenitors.

    "We have derived special types of neural cells called oligodendrocyte progenitors..."

    ~See you at the SCIWire-used-to-be-paralyzed Reunion ~

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