As I posted on the alternative YMB, Imetelstat, Tefferi and Grynznov would appear to be a great medical hoax, if Mayo Clinic and JNJ were not fully supporting them. What is JNJ planning.
The important observation is that both Tefferi and Grynznov are talking in public, with JNJ/Janssen's endorsements. The mystery is that we cannot find out what they said. WHY?
These presentations are semi-public. Someone was there.
Why is it so difficult to get a copy or summary of these presentations (Tefferi & Grynznov)? This is information that needs to be public.
I doubt that Tefferi (Sep. 17) and Gryaznov (Sep. 28) would have presented "bad news" about Imetelstat. However the top-secret security is a mystery. Perhaps we are witnessing the Manhattan Project for cancer. Our spys will break the code eventually.
Can anyone explain what happened? Why has the old format made a comeback? The new format seems to have the interesting content. Why are they independent and non-interacting?
ASCO told us quite a bit. It told us that the conclusions from the Mayo Clinic (MF) pilot studies are intact, and the information published in NEJM is still valid. JNJ would not be focusing on "unmet medical needs" for IMET unless they had irrefutable trial and patient data in hand to satisfy both the EMA and FDA. JNJ is taking all the risks now from getting approvals, manufacturing, distributing and marketing IMET.
Geron is along for the very profitable ride, as JNJ does the heavy lifting with worldwide trials and seeking worldwide approvals. Geron chose well in finding JNJ to "captain the IMET ship". There is no question that IMET works and is safe. The questions are now about genetics, mutations, and IMET's reach beyond blood cancers as part of the "cancer moonshot" alone and in combinations.
We can all trust JNJ to push IMET to its limits medically. IMET saves lives.
Besides the fact that IMET "works" for "unmet medical needs", it has a very good safety profile. It was seriously challenged by the "liver-holds" (Geron's lack of proper data + Incyte's protection of JAK) but that is all well behind us. Juno's safety problems in some ways help IMET. IMET, with ODD approvals (FDA, EMA), is in line for advanced approvals. JNJ is in control with the data, and the strong medical considerations.
The "data-bank" at Janssen is bulging. When will we get the details? JNJ, by now, has a massive database and sufficient results and analyzes to confirm earlier MF data from Mayo clinic. These new trials were scheduled to last 24 weeks. When JNJ final releases their upgraded MF studies, they will be statistically meaningful (FDA & EMA compliant) and genetically mapped to define the most likely successes. The IMET road is ASCO-2016 to ASH-2016 with some important stops in-between. The focus is unmet medical needs that IMET can fill.
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.
I continue to believe that JNJ is very serious and successful in conducting Imetelstat (IMET) trials, and that they have both the FDA's and EMA's encouragement and recognition (beyond granted ODD status) in developing IMET. The data is in place for full and advanced approvals to meet "unmet needs" (ASCO-2016) for blood cancer patients.
This is consistent with JNJ wanting to keep a competitive advantage, and maintain silence as long as possible, but it is very difficult for current blood cancer victims. ASCO has told us that everything is going as planned, and the good safety profile is being maintained for IMET (IMET for "unmet needs", with expanding trials and combination drugs). JNJ is being too conservative and too cautious, IMO. Let the "good news" roll.
JNJ is gathering data and results on a continuing basis with ongoing and new trials. JNJ has all of the data, all of the results and all of the conclusions. This part of the "cancer-moonshot" is intact. There is no longer any doubt about the importance of telomere length and the enzyme telomerase in the life of a cancerous cell. Imetelstat controls that relationship in blood cancers, and perhaps all cancers (continuing research). The relative safety of IMET puts it on the A-list for advanced approvals, active use in treating blood cancers (ET, MF, MDS, AML and others).