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lws2000 113 posts  |  Last Activity: Jul 14, 2016 2:27 PM Member since: Nov 21, 2001
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  • lws2000 lws2000 May 26, 2016 10:57 AM Flag

    That is the question. There does not seem to be anything wrong with Imetelstat. JNJ would not be continuing so many trials, and starting new ones, if the medicine was not "transformative". Piper Jaffray is still showing $10. This is a JNJ project.

  • lws2000 lws2000 May 26, 2016 11:20 AM Flag

    It is clear from the IMET (Imetelstat) experience that a great medicine does not translate into a great stock without the FDA endorsement. On the other hand, IMET meets all of the criteria for FDA approvals beyond ODD status (safe, effective, live saving, remissions, unique, disease modifying, perhaps cures).

  • Reply to

    As Long as J&J are in so am I

    by mwiener77 May 26, 2016 7:55 PM
    lws2000 lws2000 May 26, 2016 11:23 PM Flag

    20% of a critical component in the treatment and cure for cancer (alone and in combinations) is still a very large number.

  • lws2000 lws2000 May 27, 2016 6:43 AM Flag

    Now is the time to focus on ASCO, which is next week. The 2016 ASCO Annual Meeting is the premiere oncology event. With more than 30,000 oncology professionals attending and over 50 percent of them from outside the United States, taking this opportunity to engage with a vast audience. Think Dr. Teferri, world-class oncology associates, Mayo Clinic, JNJ/Janssen and Imetelstat.

    Imetelstat (IMET) is a "transformative cancer medicine (JNJ)" that will be introduced and updated for the whole oncology world to review. IMET fills unmet medical needs, JNJ controls IMET, and Geron owns IMET.

  • lws2000 lws2000 May 27, 2016 9:22 PM Flag

    Subject: "The telomerase inhibitor imetelstat in patients (pts) with intermediate-2 or high-risk myelofibrosis (MF) previously treated with Janus kinase (JAK) inhibitor: A phase 2, randomized study."

    Remember that we were told that these trials were about the worst of the MF patients. These were patients that had been on JAK and could no longer tolerate it. They were literally dying without hope. The Janssen (JNJ)-Imetelstat trials were about giving them another chance to survive.

    I don't know what will be presented at ASCO, but such a group of preeminent oncologist (led by Dr. Tefferi) looks very impressive. They must have positive results. We will soon find out. The concept is that if IMET can succeed with the sickness among us, it is a very good medicine. The question of very early treatment with IMET may not be addressed here, but that is the other end of the spectrum

  • lws2000 lws2000 May 28, 2016 3:46 PM Flag

    From the Abstract---Imetelstat fills the "great unmet need for effective therapy" in a platform of blood cancers. That is the unescapable conclusion in the abstract. JAK is not effective; IMET is effective.

    From Abstract: TPS7079

    "Background: MF is a Philadelphia chromosome negative myeloproliferative neoplasm, with a relatively poor prognosis. Ruxolitinib, a JAK1/JAK2 inhibitor, is the only approved therapy for MF, and there are no approved treatment options for pts who fail ruxolitinib. There is a great unmet need for effective therapy for this pt population. Imetelstat sodium is a 13-mer oligonucleotide that specifically targets the RNA template of human telomerase and is a potent competitive inhibitor of telomerase enzymatic activity (Asai et al, Cancer Res 2003; Herbert et al, Oncogene 2005). A pilot study of imetelstat therapy in MF demonstrated complete and partial remissions, including some molecular remissions (Tefferi et al, N Engl J Med2015). Based on the novel mechanism of action imetelstat may provide clinical benefit to pts with intermediate-2 or high-risk MF with refractory/relapsed disease after JAK inhibitor therapy."

  • lws2000 lws2000 May 30, 2016 11:02 PM Flag

    Imetelstat's medical successes and Geron's PPS are unrelated now. Only JNJ can change that. ASCO could be a step in that direction.

  • lws2000 lws2000 Jun 1, 2016 11:30 AM Flag

    JNJ and the FDA have worked closely together on numerous medicines with some recently receiving breakthrough status. Imetelstat will be no different.

  • lws2000 lws2000 Jun 2, 2016 8:01 AM Flag

    ASCO is here: We will soon find out how much the Tefferi/ Mayo Clinic/ Janssen-JNJ/ World-Class-Oncologist team will reveal about Imetelstat (IMET) at this time . ASCO is a very important step to ASH 2016, with several stops along the way. The Mayo Clinic data and results are being combined with the continuing data from the JNJ trials. IMET fills the gap ( "great unmet need for effective therapy"). JNJ is in control.

    ASCO ANNUAL MEETING
    Meeting Dates: June 3-7, 2016
    Exhibit Dates: June 4-6, 2016
    McCormick Place ~ Chicago, Illinois

  • lws2000 lws2000 Jun 3, 2016 10:34 AM Flag

    IMET has already met expectations (tantamount to a cure, transformative cancer medicine, opens cancers for combination medicines, remissions, disease modifications, etc.). ASCO is only one step on the information road that is controlled by JNJ.

  • lws2000 lws2000 Jun 3, 2016 2:41 PM Flag

    We all know that Trump has been a Democrat all of his life. Trump is determined to ensure Hillary's election, and push his TV/survival series to new records.

  • lws2000 lws2000 Jun 3, 2016 3:09 PM Flag

    Thanks bigkosh---(excerpt) --major milestone to be made public

    "During the annual meeting of shareholders held on May 17th, Scarlett said that he would make any significant changes to the dosing arms public as this would be a major milestone. The focus of the data review is to determine whether to maintain the current two dosing arms in the study (4.7 mg/kg and 9.4 mg/kg). I believe this milestone is likely going to be made public in the next 4-7 weeks.

    It is important to remember the 9.4 mg dosage is what Geron determined to give patients the best combination of safety and efficacy, based on the groundbreaking pilot study by preeminent Hematology doctor, researcher and professor, Dr. Ayalew Tefferi of the Mayo Clinic. The unprecedented study was the first conducted showing a significant percentage of complete and partial responses in Myelofibrosis patients.

    The 4.7 mg dosage is the lowest dosage where the company predicts Telomerase inhibition would occur. Dr. Scarlett confirmed that the 9.4 mg dosage provided the best risk/reward during the pilot study during the Q&A section of the annual shareholders meeting (listen beginning at minute 55 of the webcast link).

  • lws2000 lws2000 Jun 3, 2016 4:24 PM Flag

    Dr. Tefferi and his worldwide associates are not in Chicago to sightsee. They will have something significant to say about IMET. We don't know if anything that they say can move Geron's PPS higher, but good news is better than bad news. IMET is a medical success, but Geron's PPS is in a parallel, disconnected universe. ASCO is on the road to ASH with stops in-between (journals such as NEJM, conferences, press releases).

  • Reply to

    Janssen Interim Results

    by blackmarango Jun 4, 2016 4:45 PM
    lws2000 lws2000 Jun 4, 2016 5:35 PM Flag

    BlackM---You are obsessed wilt "Chippy". He never said that the JNJ trial results would not be released on an interim basis. He said that he would not release them, so we should look to JNJ and their trials for new information (interim and beyond). "Chippy" is not part of JNJ (Janssen) or the ASCO presentation, but they may use him from time for the release of JNJ-IMET information, as a spokesman.

    Dr. Tefferi represents JNJ and Mayo Clinic in all things related to IMET as their combined principle investigator. ASCO is about Dr. Tefferi, Mayo Clinic, JNJ (Janssen), world class oncologists, plus IMET vs. JAK. JNJ will release information on the "road" (from ASCO to ASH2016) about Imetelstat.

  • lws2000 lws2000 Jun 4, 2016 6:26 PM Flag

    Dr. Tefferi represents JNJ and Mayo Clinic in all things related to IMET as their combined principle investigator. ASCO is about Dr. Tefferi, Mayo Clinic, JNJ (Janssen), world class oncologists, plus IMET vs. JAK. JNJ will release information on the "road" (from ASCO to ASH2016) about Imetelstat. JAK has been recognized and approved by the FDA, but JNJ will show that IMET is the superior medicine at ASCO and beyond.

  • lws2000 lws2000 Jun 5, 2016 11:14 AM Flag

    Here is the material available to us today (Sunday, June 5):

    The telomerase inhibitor imetelstat in patients (pts) with intermediate-2 or high-risk myelofibrosis (MF) previously treated with Janus kinase (JAK) inhibitor: A phase 2, randomized study.

    Imetelstat fills the "great unmet need for effective therapy" in a platform of blood cancers. That is the unescapable conclusion in the abstract. JAK is not effective; IMET is effective.

    From Abstract: TPS7079

    "Background: MF is a Philadelphia chromosome negative myeloproliferative neoplasm, with a relatively poor prognosis. Ruxolitinib, a JAK1/JAK2 inhibitor, is the only approved therapy for MF, and there are no approved treatment options for pts who fail ruxolitinib. There is a great unmet need for effective therapy for this pt population. Imetelstat sodium is a 13-mer oligonucleotide that specifically targets the RNA template of human telomerase and is a potent competitive inhibitor of telomerase enzymatic activity (Asai et al, Cancer Res 2003; Herbert et al, Oncogene 2005). A pilot study of imetelstat therapy in MF demonstrated complete and partial remissions, including some molecular remissions (Tefferi et al, N Engl J Med2015). Based on the novel mechanism of action imetelstat may provide clinical benefit to pts with intermediate-2 or high-risk MF with refractory/relapsed disease after JAK inhibitor therapy."

    Author(s): Ayalew Tefferi, Naseema Gangat, Dietger Niederwieser, Jan Van Droogenbroeck, Maria R. Baer, Jean-Jacques Kiladjian, Ronald Hoffman, Guido Finazzi, Francisco Cervantes, Jason R. Gotlib, Shireen Sirhan, Jane Apperley, Angélique Langlois, Ying Wan, Laurie Jill Sherman, Souria Dougherty, Faye Feller, Olatoyosi Odenike; Mayo Clinic, Rochester, MN; University of Leipzig, Leipzig, Germany; AZ Sint-Jan AV Brugge, Brugge, Belgium; University of Maryland Greenebaum Cancer Center, Baltimore, MD; Hôpital Saint-Louis & Université Paris Diderot, Paris, France; Tisch Cancer Institute, Mo

  • lws2000 lws2000 Jun 5, 2016 2:10 PM Flag

    Tefferi and associates are in Chicago, from all over the world, to talk about Imetelstat, not to sightsee. I believe they will have something new and serious to present. We will know tomorrow.

  • lws2000 lws2000 Jun 5, 2016 3:27 PM Flag

    Good find. The IMET vs. JAK debate cannot be concluded without Janssen data.

  • lws2000 lws2000 Jun 5, 2016 7:38 PM Flag

    "These 18 scientist know everything (medically and scientifically) that can possibly be known about Imetelstat to date. The question is about JNJ and how much they are willing to tell us at this point in time (ASCO). ASCO is a combination of lectures, papers, posters and a general exchange of oncology knowledge from all over the world. ASCO and ASH are the two major oncology conferences, with about 30,000 worldwide attendees this year at ASCO.

    There is a "knowledge-road" in place for Imetelstat (ASCO to ASH 2016) with other conferences, press releases and journals (NEJM for example) as major contributors. We will know more on Monday, but IMET already appears to be a major success with more good news coming. Dr. Tefferi, Mayo Clinic and JNJ are leading the way."---Previous

    ASCO-2016 will go into the history books tomorrow, but the JNJ/Janssen Imetelstat trials will continue. We will soon find out how much new IMET information JNJ is willing to release now. This is not the end, but it is the beginning.

  • ASCO Post

    Ayalew Tefferi, MD, on Imetelstat as Therapy for Myelofibrosis

    The ASCO Post is pleased to present this special video series of interviews by and with leaders in oncology. Click on the thumbnail to view the entire interview.

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