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).
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).
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.
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.
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
JNJ and the FDA have worked closely together on numerous medicines with some recently receiving breakthrough status. Imetelstat will be no different.
Imetelstat's medical successes and Geron's PPS are unrelated now. Only JNJ can change that. ASCO could be a step in that direction.
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."
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
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.
20% of a critical component in the treatment and cure for cancer (alone and in combinations) is still a very large number.
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).
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.
I believe ASCO is designed to feature something significant that has never before been presented. Dr. Tefferi and his very large group of international associates will have something positive to say that will continue the good news about Imetelstat.
I have always thought that early detection and getting to the cancer stem cells in the blood were part of the story for treating cancer, preventing cancer (cancer vaccines), and retaining remissions for a very long time.
I did not hear that. I thought he was upbeat. I heard that IMET is now JNJ's responsibility, that we should look at JNJ's completed and continuing trials, and that the trials were going well.
JNJ is collecting all this data and conducting all of these trials (101 worldwide) with some purpose in mind. They have already said that Imetelstat is a "transformative cancer drug". Certainly they expect to manufacture, develop and use this drug (blood cancers, then all cancers) for treatment and research. They know that it works and is safe. ASCO will reinforce that.