Two legitimate ASCO-Imetelstat-Tefferi-2016 poster sites: imetelstat.eu & Geron website (investors/events/past events).
JNJ is in full control of the trials and the release of information. JNJ and the FDA work together. IMET has passed all hurdles for new approvals (safe, unique, remissions, disease modification, unmet medical needs, saves lives).
There is more to come with all good news and no bad news on the road to ASH-2016 (follow-up to ASCO-2016, journals like the NEJM, other health conferences, JNJ's trials sites in 12 countries, new approvals worldwide beyond ODD, etc.).
No body on this board thinks that IMET will be denied advanced approvals by the EMA and the FDA. JNJ knows what they are doing.
There is no question that IMET works. ASCO focused on IMET, and patients' needs now ("unmet medical needs"). IMET meets all criteria for advanced approvals. Mayo Clinic (Dr. Tefferi) had remissions and disease modifications never seen before (MF). JNJ has confirmed that study and has expanded the trials (near 100 worldwide, MF, MDS, with AML coming).
Various descriptions of Imetetstat: 1. transformative cancer drug, 2. unprecedented remissions, 3. disease modifications never seen before (blood cancers), 4. saves lives, 5. safe to use, 6. enhanced effectiveness in combinations.-- (Previous)
This is an outline of Imetelstat as part of any cancer program and Joe Biden's "cancer moonshot". Of course the FDA also knows this with all of the details. The "IMET Story" is almost complete. All that is needed is advanced approvals from the FDA or anyone of the 12 ASCO listed countries.
JimPier---This is directly from the poster:
"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. "
I am interested in the medical science, which appears to be solid (Nobel Prize, Mayo Clinic Pilot trials, JNJ continuing trials). Geron's PPS is in a different universe (hedge funds, manipulation, etc.), but someday the two will merge. One has to believe that JNJ knows what they are doing.
There is no negative news about Imetelstat (even in the rumor mill). With only positive news and "unmet medical needs", it seems to me that the FDA and the EMA approvals are a given. I see no reasons for advanced approvals to be withheld, but no one knows JNJ's plan for platform (blood cancer) approvals.
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.
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."
BlackM--I would guess that all of the thumbs down votes were the same people that vote all of your posts down (probably multiples). The true vote is likely 10 to 0 favoring IMET.
IMET's successes and Geron's PPS are uncorrelated for now (until new approvals). A new drug is not accepted by the bulk of investors until it is approved. ODD status (USA & EU) already is in place.
JNJ has already absorbed Geron (one way or another) and that is a good thing. JNJ will keep Geron out of trouble (legally, financially, medically). JNJ will not cheat, lie or falsify anything that concerns IMET, but they are a tough and proper task master. The FDA and the EMA will listen to them. JNJ, by recent accounts, is the most respected company in the USA.
Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma
This study has been completed.
First received: November 16, 2010
Last updated: April 13, 2016
Last verified: April 2016
This is an open label Phase II study to determine the rate of improvement in response of patients with previously treated multiple myeloma to imetelstat alone or in combination with lenalidomide maintenance therapy. This study will include multiple myeloma patients who either have achieved disease stabilization or who have achieved at least a partial response (PR) but failed to achieve a complete response (CR) after cytoreductive therapy for multiple myeloma; ie, have detectable but non-progressing disease and will most likely relapse.
JNJ is working full time to get the words "accelerated" and "approval" from the FDA, the EU and others on 3 continents. Considering JNJ resources and IMET's safety profile and effectiveness, I have no doubt that they will succeed.
STATUS (from ASCO poster)
• Approximately 97 sites are planned in 12 countries (Figure 3).
• Enrollment began in June 2015 and is ongoing.
• As of May 25, 2016, there are 77 active sites.
• South Korea
• United Kingdom
• United States
ASCO-2016 is the entry point to ASH-2016. There are several major health conferences along the way that will tell us more about IMET in continuing and expanding JNJ trials. The FDA and EMA advanced approvals could come at anytime. JNJ/Janssen's "medical-actions" concerning IMET are only good.
JNJ, as the most respected company in the USA, certainly has the deep pockets to see IMET through many worldwide trials, for a variety diseases with and without other medicines. Money and time are no objects to them. IMET trials would only proceed, if they confirmed Mayo Clinic's early successes, and showed additional potential.
Patients' "unmet needs" are focusing and accelerating the process (ASCO-2016), and both the FDA and EMA are fully informed (ODD status). New approvals (beyond ODD) are coming soon (logic and unmet medical needs that saves lives), with new data and reliable statistics
From a investors point of view, Geron no longer exist as a drug company, but is a vehicle to get into JNJ in a very profitable way. Obviously, a 1 point gain in Geron is about a 30% gain, while a 1 point gain in JNJ is about a 1% gain. The speculation is that JNJ will get IMET approved (beyond ODD), and that JNJ will continue to control IMET, and perhaps absorb all of Geron for cash or JNJ stock. IMET is manufactured, distributed, and analyzed (trial results) by JNJ. Geron, at this point in time, has an investors interest in IMET, as a major stock holder.
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.
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.
I see no reason for JNJ to hold back information other than organization and to prevent a piecemeal approach that could be questioned. The Imetelstat infusions (JNJ trials) were started in June 2015 (one year now) with 12 countries and 77 sites are now active (see poster). There is no shortage of data, and the patient's unmet needs are compelling. It is a waiting game that is maturing.
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).
Imetelstat's medical successes and Geron's PPS are unrelated now. Only JNJ can change that. ASCO could be a step in that direction.