New article re ET

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biopearl123
Posts: 235
Joined: Fri Jul 20, 2018 5:13 pm

Re: New article re ET

Post by biopearl123 » Wed Nov 27, 2019 3:50 pm

Seems to be a rehash of old data from 2011 ASH abstract bp

biopearl123
Posts: 235
Joined: Fri Jul 20, 2018 5:13 pm

Re: New article re ET

Post by biopearl123 » Wed Nov 27, 2019 10:34 pm

So why are we seeing old ET data repackaged and published now? The article I posted is a rehash of 2011 ASH abstract, I don't see anything really new, does anyone else? Dr. Boerlacher has basically been MIA and I have not seen her as an integral part of the MF or MDS studies. This is a glaring absence as far as I am concerned. I think Scarlett is trying to bring old data to the front lines to strengthen his position with the FDA. Recall that the FDA meetings have been moved at least twice if I remember correctly. The prevention promised of the "entirety of the Imetelstat program" last year did not occur or if it did the results were kept secret and the prevention postponed for a year and a half to next March. I think this was done to let the survival data in MF play out since after all this is what Geron will use to justify approval and given the publication of this old data, Scarlett is assembling all the help he can get. We are certainly not looking at a slam dunk which is probably why he is raising money with the shelf. We finally have a placebo controlled well designed study in the MDS Part II. We has a poorly designed non placebo study in the MF study. A lot is riding on the meeting with the FDA. Lets hope the survival data carries the day. I suppose Geron could ask for approval in ET and the drug may yet be used there, hence the publication, but the market is not there for ET.

biopearl123
Posts: 235
Joined: Fri Jul 20, 2018 5:13 pm

Re: New article re ET

Post by biopearl123 » Wed Nov 27, 2019 10:34 pm

So why are we seeing old ET data repackaged and published now? The article I posted is a rehash of 2011 ASH abstract, I don't see anything really new, does anyone else? Dr. Boerlacher has basically been MIA and I have not seen her as an integral part of the MF or MDS studies. This is a glaring absence as far as I am concerned. I think Scarlett is trying to bring old data to the front lines to strengthen his position with the FDA. Recall that the FDA meetings have been moved at least twice if I remember correctly. The prevention promised of the "entirety of the Imetelstat program" last year did not occur or if it did the results were kept secret and the prevention postponed for a year and a half to next March. I think this was done to let the survival data in MF play out since after all this is what Geron will use to justify approval and given the publication of this old data, Scarlett is assembling all the help he can get. We are certainly not looking at a slam dunk which is probably why he is raising money with the shelf. We finally have a placebo controlled well designed study in the MDS Part II. We has a poorly designed non placebo study in the MF study. A lot is riding on the meeting with the FDA. Lets hope the survival data carries the day. I suppose Geron could ask for approval in ET and the drug may yet be used there, hence the publication, but the market is not there for ET.

huntingonthebluffs
Posts: 144
Joined: Wed Feb 24, 2016 12:00 am

Re: New article re ET

Post by huntingonthebluffs » Sat Nov 30, 2019 6:35 pm

Thanks for sharing this info, it certainly makes one think about what is going on with wanting to restate a previous poster. I realize our perspectives differ based on many aspects and I always defer to your experience and knowledge on the science, but I believe much can be explained based on where we are on the development runway, as we increase gradually to liftoff speed. So as more staff is added into the research mix and Geron unwinds the JNJ/Janssen project decisions and actions, don’t you think we should expect things like the ET potential to be opened again.

I think many of the original Geron cadre are MIA, including Dr. Sergei Gryaznov, Dr. Gabriela Baerlocher, Dr. Elizabeth Blackburn, etc., etc. I personally also miss Dr. A. Tefferi’s presence in the arena as well as many others outside the Geron scope who were discarded with the JNJ / Janssen agreement. As JNJ / Janssen “owned” the research and development responsibility for Imetelstat and any use in CTs for ET, PV, etc. Now that responsibility has returned to Geron in total, I expect to see action in many of the dormant but promising applications, especially in regards to combinations.

Also, if you refer back to Kanak Kanti De SA article where he interviewed Dr. Sergei Gryaznov who said he hoped Imetelstat is approved for PV/ET, provided they are clinically pursued and he noted it could have a significant impact on Geron’s valuation.

https://seekingalpha.com/article/293054 ... -for-et-pv

I know there are other options for ET treatment but Imetelstat was nearly a lights out treatment for ET. In my limited perspective, I hope it will at least add to the awareness of Imetelstat’s disease modifying nature, if not to a new treatment option.

biopearl123
Posts: 235
Joined: Fri Jul 20, 2018 5:13 pm

Re: New article re ET

Post by biopearl123 » Sat Nov 30, 2019 8:32 pm

Hi Hunting, the issue for ET is that primary treatment is essentially aspirin so there is no market despite impressive anticlonal data. This study emphasizes the selective nature of Imet (a very good attribute) across myleoproliferative diseases, in this case, ET, complementing the previously presented data in MF cell lines as well. This should help bolster favorable FDA love. I note the recent ET study is a “stimulus” study. Hard to know exactly what that means but I am interpreting this, perhaps incorrectly as a message from a well respected, peer reviewed journal to the FDA. If anyone can clarify, please do. Hope you all had a great Thanksgiving. bp

biopearl123
Posts: 235
Joined: Fri Jul 20, 2018 5:13 pm

Re: New article re ET

Post by biopearl123 » Sat Nov 30, 2019 8:52 pm

Well, here is how Blood Advances defines “Stimulus Report” : ”To complement the clinical case reports, we also recognize that there can be more basic scientific insights that also can provide novel information or mechanisms in a short format that we have termed Stimulus Reports. “

huntingonthebluffs
Posts: 144
Joined: Wed Feb 24, 2016 12:00 am

Re: New article re ET

Post by huntingonthebluffs » Sat Nov 30, 2019 10:16 pm

Thank you, I'm always grateful for another Thanksgiving Day (minus the overage on calories) and many other blessings including having ImetelChat. And likewise, I hope the holiday was a good one for you and all ImetelChat members and readers!

I guess I thought it was more challenging than just taking aspirin. The way I understand it, aspirin is not the answer to many of the symptoms, primarily just blood clots from the increased platelet counts. I think there are approximately 75K to 125K people in the US with ET, so if it is assumed 10% will develop acute leukemia and 15% develop postpolycythemic myelofibrosis (both life threatening), there seems to be some room to justify using Imetelstat. The Mayo video stated that as the disease progresses, Jakafi could be used in the treatment regimen for ET which is only palliative. I would prefer Imetelstat if heading towards crossover to the more serious diseases.

http://www.mpnresearchfoundation.org/Es ... bocythemia

Either way, everyone with ET gets aspirin, however I think a large number will start or eventually move to other regimens as well. In addition, since the median age is 60-65, I would think the prevalence is increasing as the population ages.

biopearl123
Posts: 235
Joined: Fri Jul 20, 2018 5:13 pm

Re: New article re ET

Post by biopearl123 » Sat Nov 30, 2019 11:06 pm

Hunting, you are right about that. The great unknown and Scarlett’s hidden card up his sleeve is whether “disease modification” extends to altering progression to AML. I have submitted this question to annual meetings for the past few years but it has never been adequately addressed. In theory, this could be the case. Yes ET certainly can progress as you have outlined. Geron evidently thought this market was too small to develop when Dr Boerlacher’s ET study was published. ET appears to be the ‘mildest’ MPD but I am sure patients will be grateful for better and additional therapies especially those directed at the root of the disease in the first place. To my knowledge, the long term fate of Dr. B’s patient cohort was never published, why we again do not know. bp

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