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BioTime, Inc. Message Board

gosmokeadoobie 10 posts  |  Last Activity: Aug 23, 2014 3:50 PM Member since: Nov 27, 2012
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  • gosmokeadoobie by gosmokeadoobie Aug 23, 2014 3:50 PM Flag

    why no ASH 2014 submission?

    it's called politics. scarlett & tefferi are purposely keeping mum so as not to pollute the FDA review process.

    yes, it's that simple.

  • gosmokeadoobie by gosmokeadoobie Aug 8, 2014 5:32 AM Flag

    Aug. 5, 2014 , 7:30 am EDT

    "The Myelofibrosis IST ceased enrolling patients in January 2014.

    Under Geron's sponsorship, the patients remaining in the study -
    which include patients with myelofibrosis (MF), blast phase MF, and refractory anemia with ringed sideroblasts, a subtype of the myelodysplastic syndromes (RARS-MDS)
    - will continue to receive treatment with imetelstat or continue in follow-up.

    Geron does not intend to enroll additional patients in this study.

    The company plans to use the transferred data and information from the Myelofibrosis IST to inform the design of Geron's planned Phase 2 clinical trial in MF. "

  • Reply to

    pharmacogenetic testing IND patients

    by gosmokeadoobie Jun 28, 2014 2:09 PM
    gosmokeadoobie gosmokeadoobie Jul 1, 2014 2:35 PM Flag

    and the question remains ... what other genetic markers are important?

  • Reply to

    pharmacogenetic testing IND patients

    by gosmokeadoobie Jun 28, 2014 2:09 PM
    gosmokeadoobie gosmokeadoobie Jun 30, 2014 11:35 AM Flag

    the biomarker that geron has publicly identified is telomere length.

    telomere length and imetelstat efficacy have been a talking point for more than decade.

    relatively short telomeres are a prominent feature of myeloproliferative neoplasms.

    but imetelstat is not efficacious in all patients with MPN's, as demonstrated in the MF study at the Mayo.

    so the question is, what other genetic markers are important?

  • gosmokeadoobie by gosmokeadoobie Jun 28, 2014 2:09 PM Flag

    A key goal of pharmacogenetics — the use of genetic variation to elucidate inter-individual variation in drug treatment response — is to aid the development of predictive genetic tests that could maximize drug efficacy and minimize drug toxicity.

    The clinical premise of pharmacogenetics is based on more accurate, and hence more useful, predictive medicine.

    Existing pharmacogenetic tests can be broadly divided into two categories: identifying responders or non-responders to a given drug and identifying those individuals at risk of serious adverse events.

    It is important to recognize that while pharmacogenetic tests are intended to be applied to individual patients, their predictive power is based on population samples of patients and their drug responses. This means that pharmacogenetic testing can be used for predictive medicine but not for truly personalized medicine, as the testing is based on how a group of individuals with the same polymorphisms and the same drug-response phenotype would behave in a similar clinical situation.

  • Tuesday, June 10, 2014
    San Francisco Chronicle

    "The UCSF study looked at genomic data from 1,644 patients with glioma, many of them participants in Wrensch's glioma study, and 7,736 healthy people. Earlier work by Wrensch and other colleagues had found that people with genetic variations in a gene called TERT had a higher risk of developing glioma. The new study found that variants in the gene called TERC also increased the risk.

    What piqued the scientists' interest was that both TERT and TERC are necessary for the release of telomerase, which controls production of telomeres. But they couldn't tell from their study results what the gene variants did - whether they increased the release of telomerase, reduced it, or had some other effect.

    So Walsh reached out to scientists at the University of Leicester in Britain, where they had collected data on gene variants and telomere length for 40,000 people. The Leicester data showed that the same TERT and TERC variants that increased the risk of glioma also predisposed people to have long telomeres.

    The results showed a very strong connection between glioma risk and telomere length, Wrensch said."

  • Reply to

    Green Light?

    by irishtrader52 Jun 14, 2014 9:19 AM
    gosmokeadoobie gosmokeadoobie Jun 14, 2014 1:35 PM Flag

    green light for Geron's Investigational New Drug (IND) application for imetelstat?

    not according to geron's June 12, 2014 press release....

    "Until the FDA lifts the full clinical hold on Geron's IND, the company is unable to submit any new clinical trial protocols to the FDA under the company's IND for imetelstat and is unable to initiate any new clinical trials for imetelstat in the United States."

  • gosmokeadoobie gosmokeadoobie Jun 13, 2014 12:42 AM Flag

    gosmokeAdoobie is glad to see that you've come around to reality, mainecoastlvoer1.

  • Reply to


    by mainecoastlover1 Jun 12, 2014 7:05 PM
    gosmokeadoobie gosmokeadoobie Jun 12, 2014 7:21 PM Flag

    "The lifting of the "partial hold" didn't seem to spike the pps as much as many thought it might."

    mainecoastlover1 - as you know, when the hold is lifted on geron's investigational new drug IND phase II trial ... geron's share price will move much much much higher!

  • gosmokeadoobie by gosmokeadoobie Jun 12, 2014 2:02 PM Flag

    "As previously announced, the Myelofibrosis (mayo) IST ceased enrolling new patients in January 2014"
    -06/12/2014 geron press release

    the partial hold being lifted on the mayo patient population is a nonstarter because tefferi closed the door on new patients back in january which was two months before the placement of the FDA's partial hold in march.

    so the "real" hold has yet to be lifted, but hopefully this "real" hold will be lifted soon!

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