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    Geron hopes to restart stem-cell study in 2010

    here's the latest.


    Geron hopes to restart stem-cell study in 2010
    Associated Press, 10.30.09, 01:12 PM EDT


    MENLO PARK, Calif. -- Biotechnology company Geron Corp. said Friday it hopes to pave the way for restarting human studies on a potential stem-cell treatment for spinal cord injury by conducting additional preclinical studies.

    Geron ( GERN - news - people ) said that following discussions with the Food and Drug Administration, it expects data from current preclinical studies to enable the company to restart human studies by the third quarter of 2010.

    more...

    http://www.forbes.com/feeds/ap/2009/...a_7068527.html

    #2
    It's really amazing that Geron was brilliant enough to produce the OPC1 Cells in 7 years. Yet, they are ignorant to believe these cells will ever be allowed to be tested in patients in the United States. It will never be allowed & never is a long time. The FDA will (always) find one reason or another to effectively ban testing on these cells.

    The word came down from Washington to the FDA to postpone the testing. Obama got your vote based on signing the Stem Cell initiative, then turned around and stabbed you in the back. That is how politics works. The pressure was simply to great from the religious right.

    "Geron hopes to restart stem-cell study in 2010." Hope is for suckers.

    Comment


      #3
      I don't think Obama has anything to do with FDA postponed Geron trial.

      Comment


        #4
        Geron trial

        Originally posted by Timo View Post
        I don't think Obama has anything to do with FDA postponed Geron trial.
        can any one tell me why they have 2 wait until 2010 can they pick up for where they left off from in Aug 09
        AS I SIT HERE IN MY CHAIR . I LOOK OUT UPON THE GROUND .I WONDER WILL I EVER GET UP AND WALK A ROUND ??


        http://justadollarplease.org

        Comment


          #5
          Originally posted by chasb View Post
          It's really amazing that Geron was brilliant enough to produce the OPC1 Cells in 7 years. Yet, they are ignorant to believe these cells will ever be allowed to be tested in patients in the United States. It will never be allowed & never is a long time. The FDA will (always) find one reason or another to effectively ban testing on these cells.

          The word came down from Washington to the FDA to postpone the testing. Obama got your vote based on signing the Stem Cell initiative, then turned around and stabbed you in the back. That is how politics works. The pressure was simply to great from the religious right.

          "Geron hopes to restart stem-cell study in 2010." Hope is for suckers.
          Could you post the evidence you base your statements on?

          Comment


            #6


            Obama Administration Sued to Stop Tax-Funding of Embryonic Stem Cell Research
            by Steven Ertelt
            LifeNews.com Editor
            October 9, 2009


            Washington, DC (LifeNews.com) -- A coalition of pro-life advocates including two scientists, two families, an adoption agency and the Christian Medical Association have banded together to file a lawsuit against the Obama administration in an effort to stop the expected taxpayer funding of embryonic stem cell research.
            The suit is a response to President Barack Obama's decision earlier this year to overturn the protections the Bush administration put in place preventing funding of research that involves the destruction of human life.
            World magazine indicates the pro-life advocates have sued the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) on behalf of unborn children who would be destroyed in the research funded by the departments.
            They want to stop the expected $92 million that could be funneled from taxpayer funds to embryonic stem cell research, which has never helped human patients and has yielded significant problems in studies with animals.
            "This case raises the central question of whether Congress does or does not want to fund the destruction of human embryos," pro-life attorney Samuel Casey of Advocates International told World.
            The Alliance Defense Fund and the law firm Gibson, Dunn & Crutcher are also helping the clients involved in the lawsuits.
            There are two suits and both make similar cases that the Obama order to force taxpayers to fund embryonic stem cell research violates the Dickey-Wicker Amendment, a federal law that prohibits federal funding of scientific studies that destroy human life.
            Specifically, the 1995 law stops tax-funding of "(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death."
            Because President Bush's policy prohibited funding any new research destroying human life, he was able to pay for research using older embryonic stem cells.
            "[The Obama policy] encourages you to develop an embryonic stem cell line that does not exist now," Casey told World. So now we're in court to find out what Dickey-Wicker means—again."
            The lawsuit also alleges that the NIH violated administrative rules when it wrote the guidelines for implementing Obama's decision after allowing only 34 days of public comment -- instead of the customary 60 days -- and publicly admitted ignoring 30,000 of the 49,000 public comments from people who opposed the funding.
            Nightlight Christian Adoptions, which has helped facilitate adoptions of frozen embryos who are implanted and a pregnancy carried to term, is also involved in the lawsuit.

            Buzz up!

            Printed from: http://www.lifenews.com/bio2980.html


            Copyright © 2003-2006 LifeNews.com. All rights reserved. For free daily/weekly pro-life news, email us at news@LifeNews.com.

            Comment


              #7
              Originally posted by mckeownp View Post
              Could you post the evidence you base your statements on?
              As you blanketed my entire post, this will be my first response on your request.

              Originally posted by chasb View Post

              "Geron hopes to restart stem-cell study in 2010." Hope is for suckers.

              "Hope is the worst of evils, for it prolongs the torments of man."
              - Friedrich Nietzsche

              Comment


                #8
                Originally posted by skeaman View Post
                can any one tell me why they have 2 wait until 2010 can they pick up for where they left off from in Aug 09
                ... because they continue playing with fire, manipulating public opinion and cheating potential investors, so that maybe FDA has just got sick of their obstructions . Seriously, until now I was their great fan, but they failed me. What they are doing, is a circus and let's hope there would be more serious companies on the market by this time. Not good example for persuading people that politics and funding are the biggest obstacles on the road to a cure, isn't?

                Originally posted by chasb View Post
                The word came down from Washington to the FDA to postpone the testing. Obama got your vote based on signing the Stem Cell initiative, then turned around and stabbed you in the back. That is how politics works. The pressure was simply to great from the religious right.
                It has nothing to do with (Obama's) politics, because Geron has used embryonic stem cell lines that were approved for federal funding under President Bush’s 2001 policy.

                A quote from company's announcement:

                Since Geron Corporation’s study does not use federal funds, it would not have faced any restrictions under the Bush Administration. The company has stated that the FDA approval of its study was not related to the change in the White House.
                2016

                Comment


                  #9
                  duran

                  Originally posted by Duran View Post
                  ... because they continue playing with fire, manipulating public opinion and cheating potential investors, so that maybe FDA has just got sick of their obstructions . Seriously, until now I was their great fan, but they failed me. What they are doing, is a circus and let's hope there would be more serious companies on the market by this time. Not good example for persuading people that politics and funding are the biggest obstacles on the road to a cure, isn't?




                  It has nothing to do with (Obama's) politics, because Geron has used embryonic stem cell lines that were approved for federal funding under President Bush’s 2001 policy.

                  A quote from company's announcement:
                  surely this will back fire on them if Dr wise gos ahead in January 2010 i hope that is when he is starting would there be a truth in this i can not understand this why they do this it must be to get more money if wises trials kick off and good comes out of it basically they will be FUCKED
                  AS I SIT HERE IN MY CHAIR . I LOOK OUT UPON THE GROUND .I WONDER WILL I EVER GET UP AND WALK A ROUND ??


                  http://justadollarplease.org

                  Comment


                    #10
                    hoping so
                    "That's not smog! It's SMUG!! " - randy marsh, southpark

                    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


                    2010 SCINet Clinical Trial Support Squad Member
                    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

                    Comment


                      #11
                      [QUOTE=chasb;1115033]As you blanketed my entire post, this will be my first response on your request.

                      What does that mean? 'blanketeted your entire post' What response?

                      Comment


                        #13
                        Originally posted by Duran View Post
                        ... because they continue playing with fire, manipulating public opinion and cheating potential investors, so that maybe FDA has just got sick of their obstructions . Seriously, until now I was their great fan, but they failed me. What they are doing, is a circus and let's hope there would be more serious companies on the market by this time. Not good example for persuading people that politics and funding are the biggest obstacles on the road to a cure, isn't?
                        Your statment makes no sense, is sensationalist and outright nonsense (lie?). And then 2 others reply to your disinformation thus "spinning the stupid©" and propagating more nonsense!

                        From the press release:

                        Geron and FDA Reach Agreement on Clinical Hold

                        Company and Regulatory Agency Define Path to Re-Initiate Human Trials for Spinal Cord Injury


                        MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN) today announced the company’s plan to advance clinical development of its human embryonic stem cell (hESC)-based product, GRNOPC1, for the treatment of spinal cord injury. The plan is expected to enable Geron to re-initiate the Phase I clinical trial of GRNOPC1 in patients with complete thoracic spinal cord injury and to support future expansion of the trial to patients with cervical injuries.

                        Geron has been performing a series of preclinical studies to expand the clinical program for spinal cord injury beyond patients with complete thoracic injuries. The company’s goal is to test the safety and utility of GRNOPC1 in patients with complete and incomplete (less severe) injuries in both thoracic and cervical regions.

                        As announced previously, in one preclinical study, a higher frequency of animals developed cysts in the injury site than had been seen in numerous foregoing preclinical studies with clinical grade GRNOPC1.
                        These cysts are non-proliferative, confined to the injury site, smaller than the injury cavity, and were not associated with adverse effects on the animals. As part of ongoing work to optimize GRNOPC1 manufacturing and product release, the company developed new candidate markers and assays. Data from studies using the new markers were submitted to the FDA. The IND for spinal cord injury was placed on clinical hold pending FDA review of the data.

                        Geron will complete a confirmatory preclinical study using GRNOPC1 that has been characterized by the new markers and assays, as agreed upon in discussions with the FDA. As part of the ongoing plan to advance clinical development to cervical patients, Geron had already initiated this preclinical study in an animal model of cervical injury.

                        In discussions with the company, the FDA has advised that it concurs with Geron that positive data from this study can be used to support both release of the clinical hold and expansion to cervical patients. Geron expects the data from this study to enable re-initiation of the clinical trial in the third quarter of 2010.
                        Last edited by eks; 31 Oct 2009, 5:22 PM. Reason: Brevity
                        ______
                        Awe at my magnificent coq!

                        "You may say I'm a dreamer
                        but I'm not" - J. Lennon

                        Comment


                          #14
                          .-.. . - .----. ... / ... . . / .. ..-. / -.-- --- ..- / -.-. .- -. / ..-. .. --. ..- .-. . / --- ..- - / .. / .--- ..- ... - / .. -. -.. .. -.-. .- - . -.. / -.-- --- ..- / .- .-. . / .- / -- --- .-. --- -. .-.-.- / - .... .- - / .. ... / .-- .... -.-- / .. / -. . ...- . .-. / .- -. ... .-- . .-. . -.. / -.-- --- ..- .-. / --.- ..- . ... - .. --- -. .-.-.- / -.-- --- ..- / -. . .. - .... . .-. / ..- -. -.. . .-. ... - .- -. -.. --..-- / -. --- .-. / .- .--. .--. .-. . -.-. .. .- - . / -. .. . - --.. ... -.-. .... . .-.-.- / .. / -.. --- ..- -... - / -.-- --- ..- / .... .- -.. / . ...- . .-. / .... . .- .-. -.. / --- ..-. / .... .. -- --..-- / .--. .-. .. --- .-. / - --- / - --- -.. .- -.-- .-.-.-
                          Last edited by chasb; 31 Oct 2009, 9:29 PM.

                          Comment


                            #15
                            Originally posted by eks View Post
                            Your statment makes no sense, is sensationalist and outright nonsense (lie?). And then 2 others reply to your disinformation thus "spinning the stupid©" and propagating more nonsense!
                            eks,

                            I am not sure what puzzled me more, if that was date of your injury (you are only two years post) or your infantile post. Though I'd like to raise a point in the discussion, it would be counterproductive, I suppose. It is just like talking to virgin about sex.

                            I am not going to play this game with you in any way! If you has nothing constructive to add, just shut up!
                            2016

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