What do you make of this- https://globaltrialfinder.janssen.com/t ... -002874-19
copied from YMB.
Phase III?
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biopearl123
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Re: Phase III?
00pf5272, this has been an ongoing source of great confusion. Phase III appears to be recruiting but NOT enrolling. There is a big difference. I do not doubt patients are lined up to begin study but the study is not officially in PIII since no patients have been randomized and probably won't be for a while according to Dr. Scarlett. Hope this helps. bp
Re: Phase III?
It helps, I'm just confused by the date & more importantly why Janssen is the sponsor since rights were being transferred back to Geron. I, as with other's maintain that the Science is good. That would be a question for JS: why is Janssen allowed to put their name on new trials?
Re: Phase III?
Janssen hasn't transferred the trials to GERN yet because GERN doesn't exist. They have to hire people even to supervise the new trial subcontractor. The process is going to take almost a year according to Scarlett's lackadaisical timeline.
Scarlett says there won't be a Phase 3 trial until after mid-2019.
Scarlett says there won't be a Phase 3 trial until after mid-2019.
Re: Phase III?
Of course this post doesn't dignify a response, however I see almost 400 views on this thread so I'll jump in:
Geron exists. It appears Nobel Prize winning theory is translating to "groundbreaking results" (5 years ago, as stated in the Mayo Clinic brochure, "tantamount to a cure in some cases") for patients and now a potential paradigm shift in treatment in blood cancers, with a different and unique mechanism of action for patients in dire need. Not to mention curative not palliative for MF.
While the timelines in scientific endeavors are painstakingly slow, especially in the clinic with real people's lives at stake and in a treatment with a novel MoA, the past decade of facts can't be refuted:
ET - near 100% remissions
MF - curative responses not palliative, unknown-but-extremely-long overall survival across the patients ~ look forward to more details at ASH
MDS - Transfusion Independence and on to Phase III ~ look forward to more details at ASH
AML - stunning pre-clinical results in combo from 2016. 2016!
Pan-cancer - more stunning pre-clinical from Yale showing potential action across cancers. Being that cancer at the most basic level is essentially the unimpeded growth of cells, just depends where to define the cancer -- the potential action of Imet interacting with telomeres in the cell to inhibit cell growth could be a paradigm shift.
For now Geron is working on the MDS study with the limited resources they have. Hopefully partners for clinical combo trials but first, let's ASH it out. All the potentially interested parties will be there, and I am sure they will be attending and reviewing the most up-to-date information at the Oral Presentations delivered by among the most esteemed clinicians in the world.
It's 10 years on and finally now we are on the cusp of a Phase III. Maybe two. Not sure what will be said if Geron is able to execute and initiate this Phase III, but I'm sure it will be something that screams the inner pain of that individual moreso than providing context into the company and the ongoing trials.
Geron exists. It appears Nobel Prize winning theory is translating to "groundbreaking results" (5 years ago, as stated in the Mayo Clinic brochure, "tantamount to a cure in some cases") for patients and now a potential paradigm shift in treatment in blood cancers, with a different and unique mechanism of action for patients in dire need. Not to mention curative not palliative for MF.
While the timelines in scientific endeavors are painstakingly slow, especially in the clinic with real people's lives at stake and in a treatment with a novel MoA, the past decade of facts can't be refuted:
ET - near 100% remissions
MF - curative responses not palliative, unknown-but-extremely-long overall survival across the patients ~ look forward to more details at ASH
MDS - Transfusion Independence and on to Phase III ~ look forward to more details at ASH
AML - stunning pre-clinical results in combo from 2016. 2016!
Pan-cancer - more stunning pre-clinical from Yale showing potential action across cancers. Being that cancer at the most basic level is essentially the unimpeded growth of cells, just depends where to define the cancer -- the potential action of Imet interacting with telomeres in the cell to inhibit cell growth could be a paradigm shift.
For now Geron is working on the MDS study with the limited resources they have. Hopefully partners for clinical combo trials but first, let's ASH it out. All the potentially interested parties will be there, and I am sure they will be attending and reviewing the most up-to-date information at the Oral Presentations delivered by among the most esteemed clinicians in the world.
It's 10 years on and finally now we are on the cusp of a Phase III. Maybe two. Not sure what will be said if Geron is able to execute and initiate this Phase III, but I'm sure it will be something that screams the inner pain of that individual moreso than providing context into the company and the ongoing trials.
Re: Phase III?
Ryan, I'm sorry for your pain... mine at least ended at $2.30 
Geron is not "working on the MDS study". They are hiring people to supervise a clinical-trial subcontracting company sometime after the middle of 2019.
Yes, the preclinical from 2016 is fascinating. So are the results of preclinicals in GERN's 6-thio-G.
But no one is "working" on any of these things.
Watch Shay's presentation where he compares imet and 6-thio-G:
https://www.youtube.com/watch?v=l8cL3v9Z_fs
Geron is not "working on the MDS study". They are hiring people to supervise a clinical-trial subcontracting company sometime after the middle of 2019.
Yes, the preclinical from 2016 is fascinating. So are the results of preclinicals in GERN's 6-thio-G.
But no one is "working" on any of these things.
Watch Shay's presentation where he compares imet and 6-thio-G:
https://www.youtube.com/watch?v=l8cL3v9Z_fs