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EMC Corporation Message Board

lws2000 192 posts  |  Last Activity: 13 hours ago Member since: Nov 21, 2001
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  • Reply to

    Where's the IMET

    by blackmarango Sep 16, 2014 5:09 PM

    black: We know that Tefferi has assumed some duties for Geron, so he must talk to Scarlett. We also know that the Mayo-FDA-hold is gone, with Tefferi's intervention. Scarlett may be a person (for some reason) that the FDA does not want to talk to, and Tefferi is a surrogate. Scarlett is likely spending most of his time looking for an "Imetelstat-deal" . (IMO)

  • Reply to

    Where's the IMET

    by blackmarango Sep 16, 2014 5:09 PM

    My Opinion: Scarlett, Tefferi and the FDA talk to each other, and have an agreement in place. Mayo and Geron are combining their data to conform to the FDA's procedures and wishes. The reasons for the level of secrecy, that you talk about, are not clear (partner discussions, inside information, FDA direction ???), but everything seems be under control as ASH approaches. I am confident that Imetelstat is already a success from the medical point of view. There is hedge fund manipulation of the small biotechs (other posts on this board), and Geron appears to be a victim. If I am correct, the PPS cannot be held down much longer, as more news about Imetelstat becomes available. ASH and ASH abstracts will put everything into perspective.

  • Reply to

    Where's the IMET

    by blackmarango Sep 16, 2014 5:09 PM

    These are good questions: 1. Who is manufacturing IMET?; 2. In what quantities is it being produced?; 3. Who is using it and for what purposes?; 4. Who is paying for it? ; 5. Who decides who can use it?

    It is clear that IMET is available to Mayo, NCI, Yale and other medical schools, and Amgen. We will learn the details at ASH. We should know more about the framework now. Clearly, there have been IMET successes. Scarlett is out looking for a partner, while Tefferi combines data and talks to the FDA.

  • Reply to

    When will Chip break his silence?

    by hairypotter9 Sep 16, 2014 3:41 PM
    lws2000 lws2000 Sep 16, 2014 5:42 PM Flag

    My Opinion: Scarlett's main function these days is to find a partner (could be a merger or a buyout). The combination data is being coordinated by Dr. T, who is also leading discussions with the FDA. "Chip will break his silence" when there is a major announcement. ASH will be the pinnacle, but some important information will be forthcoming before that event.

  • Reply to

    HER2-positive Breast Cancer trial still running

    by tazamatic2002 Sep 16, 2014 10:34 AM
    lws2000 lws2000 Sep 16, 2014 11:49 AM Flag

    If you "watch for either side effects" you will have some very dead patients from cancer in a short time. That, not only makes no sense, but is cruel.

  • lws2000 lws2000 Sep 14, 2014 5:51 PM Flag

    Consider "Chippy" a market specialist trying to find the right deal for Geron (partner, merger, buy-out). He is out of the medical-science-FDA loop. Geron owns Imetelstat, but he is listening very closely to others.

  • lws2000 lws2000 Sep 14, 2014 5:41 PM Flag

    PREVIOUS********Imetelstat's future will be determined by the presentations at ASH. We do know that Mayo Clinic, NCI, Amgen, Yale Medical and others have some very interesting and important thoughts and results to share. ASH will open new paths into the future of medicine ( telomeres-cancer-cancer stemcells).********
    ***************************************************************************************************************
    There is no way that Imetelstat can be kept out of the reach of needy patients, and off the market considering the information that is coming from Mayo, NCI, Amgen, Yale, Mass. Medical, etc. The Geron-FDA impasse is a mystery, but it may be as simple as the FDA making a mistake, and trying to find a good way to save face. This is unfortunate. I don't believe there has been any corruption, but I am less sure about politics, considering that other products would be impacted by Imetelstat's "green-light". The combination of data (Mayo-Geron), with the FDA's apparent approval, looks very positive.

  • lws2000 lws2000 Sep 13, 2014 9:42 AM Flag

    The combination of data will eliminate all holds. I think it could happen in a very few days (to everyone's surprise), but I can wait for ASH. Mayo has decided to use their data to finish-off all holds. Imetelstat and patients will be the winners. All potential ASH presentations appear positive.

    (REFERENCE, PREVIOUS (from trail)***********They (FDA) released the partial hold on Mayo. Mayo transferred the IND back to Geron. Geron ditched the ET trial and will get approval for the P2 MF trial based on the Mayo trial. Acceptance by the FDA will happen any day now."**********

  • lws2000 lws2000 Sep 13, 2014 9:08 AM Flag

    PREVIOUS (from trail*****)--- "Chippy tried it in liquid cancer ET and had great results 100% so he convinced Mayo to test it in MF. They got historic results of remission in MF first time ever and raised the cash $100 mil . Then it came out that a single 80+ year old patient that had hepatitis and complications from other conditions and previous drug use died. FDA picked up on it and placed holds They released the partial hold on Mayo. Mayo transferred the IND back to Geron. Geron ditched the ET trial and will get approval for the P2 MF trial based on the Mayo trial. Acceptance by the FDA will happen any day now."*****
    -------------------------------------------------------------------------------------------------------------------------------------
    This seems to be accurate. It begs the question of special problems between Geron and the FDA, that are non-medical. ASH will put everything into prespective. Imetelstat has a very promising future, but who will control it, and who will own it are subjects for the rest of 2014 and 2015. An investment here, from a medical point of view, has some very strong scientific and medical data to support it.

  • PREVIOUS******There does seem (to me) to be something going on between the FDA and Geron that has nothing to do with the patients welfare, or the effectiveness and safety of Imetelstat. It seems to apply only to Geron, and not Mayo Clinic or the NCI. It is too far removed from public viewing to know exactly what that is. The speculation has been endless. This should be resolved before ASH. "All is well, that ends well". ******
    ---------------------------------------------------------------------------------------------------------------------------------------
    Imetelstat's future will be detemined by the presentations at ASH. We do know that Mayo Clinic, NCI, Amgen, Yale Medical and others have some very interesting and important thoughts and results to share. ASH will open new paths into the future of medicine ( telomeres-cancer-cancer stemcells).

  • Reply to

    Why Would The FDA Keep The Hold If

    by mruyog Sep 12, 2014 1:12 PM
    lws2000 lws2000 Sep 12, 2014 8:29 PM Flag

    There does seem (to me) to be something going on between the FDA and Geron that has nothing to do with the patients welfare, or the effectiveness and safety of Imetelstat. It seems to apply only to Geron, and not Mayo Clinic or the NCI. It is too far removed from public viewing to know exactly what that is. The speculation has been endless. This should be resolved before ASH. "All is well, that ends well".

  • Reply to

    On Going Study; No Liver Problems; NCI

    by comsensea Sep 11, 2014 12:28 PM
    lws2000 lws2000 Sep 12, 2014 12:32 AM Flag

    More Information (Phase 2)
    ----
    NCT01836549 (Imetelstat)

    * Phase II:

    I. To estimate the sustained objective response rates (complete response (CR) plus partial response (PR), sustained for at least 6 weeks) to imetelstat administered intravenously on Days 1 and 8 of a 21-day course at the recommended Phase II pediatric dose, 285mg/m2, in children with recurrent or refractory HGG, ependymoma or DIPG. Independent estimates of the objective response rates will be made for each of the three strata, two of which are histologically defined.

    SECONDARY OBJECTIVES:

    * Phase II only:

    I. To assess evidence of telomerase expression by detection of hTERT mRNA and TERC RNA levels by quantitative reverse transcription polymerase chain reaction (qRT-PCR) and telomerase activity by TRAP in archival tumor tissue (for HGG, and ependymoma strata) and to explore association of telomerase positivity with objective response and progression-free survival (PFS).

    II. To estimate the stratum-specific PFS distributions of children with recurrent or refractory HGG, ependymoma or DIPG treated with imetelstat.

    * Molecular Biology and Phase II:

    I. To characterize the plasma and CSF pharmacokinetics of imetelstat in children with recurrent or refractory HGG, ependymoma or DIPG.

    II. To assess evidence of telomerase expression by detection of hTERT mRNA and TERC RNA levels by qRT-PCR, telomerase activity by TRAP, and telomere length by telomere terminal restriction fragment (TRF) analysis in PBMNCs prior to treatment with imetelstat and to assess evidence of telomerase inhibition by TRAP and telomere shortening by TRF analysis serially on treatment with imetelstat.

    III. To compare incidence of Alternative Lengthening of Telomeres (ALT) mechanism in pediatric HGG, or ependymoma as determined by four different assays 1) ATRX/DAXX nuclear localization by immunofluorescence (IF) assay; 2) telomere-specific signal by fluorescence in situ hybridization (FISH); 3) telomeric terminal restriction

  • Reply to

    On Going Study; No Liver Problems; NCI

    by comsensea Sep 11, 2014 12:28 PM
    lws2000 lws2000 Sep 11, 2014 6:34 PM Flag

    PHASE 2 = SAFE; now let's find out how well it works.
    ****************************************************************
    Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 0, 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population.

    Phase 0: Pharmacodynamics and Pharmacokinetics
    Phase 1: Screening for safety
    Phase 2: Establishing the efficacy of the drug, usually against a placebo
    Phase 3: Final confirmation of safety and efficacy
    Phase 4: Sentry studies during sales

  • Reply to

    On Going Study; No Liver Problems; NCI

    by comsensea Sep 11, 2014 12:28 PM
    lws2000 lws2000 Sep 11, 2014 3:39 PM Flag

    This study, with NCI, would seem to end all arguments about the safety of Imetelstat, including liver effects.
    -----------------------------------------------------------------------------------
    Purpose (Imetelstat)

    This molecular biology and phase II trial studies how well imetelstat sodium works in treating younger patients with recurrent or refractory brain tumors. Imetelstat sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

    Condition

    Intervention

    Phase 2

    Recurrent Childhood Anaplastic Astrocytoma
    Recurrent Childhood Anaplastic Ependymoma
    Recurrent Childhood Diffuse Astrocytoma
    Recurrent Childhood Ependymoma
    Recurrent Childhood Giant Cell Glioblastoma
    Recurrent Childhood Glioblastoma
    Recurrent Childhood Gliosarcoma
    Recurrent Childhood Oligodendroglioma
    Recurrent Childhood Brain Stem Glioma
    Drug: imetelstat sodium
    Other: laboratory biomarker analysis
    Other: pharmacological study
    Phase 2

  • lws2000 lws2000 Sep 9, 2014 4:52 PM Flag

    I do not know the details, but from what I read an Amgen drug and Imetelstat (from Geron) were combined in several tests on various types of cancer cells. The combinations were significantly more effective than either drug alone.

    Please correct or enlighten me. This would suggest to me that Amgen was aware of these tests, and has an interest in Imetelstat. Amgen definitely has very deep pockets.

  • lws2000 lws2000 Sep 9, 2014 1:49 PM Flag

    I don't think that the hold matters anymore. Scarlett, IMO, is looking for a strong deep-pocketed partner (or a merger). All of the data, trials and relations with the FDA are being handled by Tefferi, with combination authority at Mayo & Geron. I am only looking at ASH & Mayo for medical information. Amgen's use of Imetelstat is very interesting.

  • lws2000 lws2000 Sep 9, 2014 11:56 AM Flag

    Imetelstat is strong, but Geron markets are completely controlled. We still have no idea who is controlling them, and how they do it. They are making money. ASH is our major hope, with positive medical information, that cannot be ignored.

  • lws2000 lws2000 Sep 8, 2014 5:41 PM Flag

    The publicity from ASH, no negative news about Imetelstat, and Mayo Clinic's successes will drive the PPS much higher. Geron will not try to go it alone. I don't know if they will choose a partner or a merger, but Imetelstat has no opposition in science and medicine that I can find. Market factors are still with us, but ASH will take care of them. This drug is too good. Amgen's work with combinations is amazing.

  • lws2000 lws2000 Sep 5, 2014 8:54 PM Flag

    ASH will determine the future of Imetelstat and Geron. Either Imetelstat is a great drug (with future potential), or we have been misled. There is no way to hide the truth after the ASH presentations. I have not seen any negative papers to date (anywhere), so I am hoping for the best.

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