Take aways from Oppenheimer

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Fishermangents
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Take aways from Oppenheimer

Post by Fishermangents » Wed Dec 09, 2015 6:33 pm

- IMerge contains already a Phase 3 protocol. The primary outcome is TI. IMegre is intended clearly as a registration enabling study. Expecting to see significant proportion of TI as well as symptomatic improvement.
- the decisive argument for Tefferi as well as JnJ to put their cards on imetelstat is that imetelstat showed to be able to take away the malignant progenitor cells to continue proliferate. Tefferi saw complete remissions with imet. Patients were clearing their bone marrow in three months. Symptoms went away. That illustrates the transformative nature of imet to the disease. That’s why Jansen was interested.
- Anemia is a good sign of efficacy. Most patients with CR’s had significant cytopenia. After 11-14 days the bone became repopulated with healthy progenitor cells and blood counts improved.
- the cooperation with JNJ is comprehensive and goes very well. JNJ has taken over all elements of the drug development. The partners are very succesful in finding consensus on how to move forward through a joint governance structure, which consists of a Joined Development Committee and a Joined Steering Committee (amongs others).
- AML trial will likely be a combination of imetelstat and a cytoreductive drug due to the complex and agressive nature of blast crises AML. Such patients have short survival and no treatment options.
- Geron looks for other programs in order to leverage the future cash flows from JnJ. Dr. Scarlett is very selective: only platform based technologies may become candidate.

biopearl
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Joined: Wed Dec 09, 2015 12:12 am

Re: Take aways from Oppenheimer

Post by biopearl » Wed Dec 09, 2015 10:07 pm

Initially I thought the myelosuppression from Imetelstat was a toxic effect on remaining normal bone marrow. Dr. Scarlett implied that this is NOT the case and that the cells from the malignant clone are still functional and by killing the malignant clone anemia, cytopenias etc ensure. Interesting. Then the bone marrow repopulates with what ever remaining normal marrow stem cells are left since the malignant clone has been impacted by Imet. Interesting.

I_Believe_Irish
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Joined: Thu Dec 10, 2015 2:38 am

Re: Take aways from Oppenheimer

Post by I_Believe_Irish » Thu Dec 10, 2015 2:58 am

Fishermangents,

Excellent post and thank you for making this forum available.

If there is anything I can do to assist you with administration, funding, or anything else related to this site, just post a message to me or email me at my registration email and I will get going on it.

I think the move by Dr. Scarlett entering into the agreement with Janssen was a brilliant strategic move that will pay off for equity holders and the progress getting a combined phase2/phase 3 trial moving so quickly is phenomenal.

I look forward to being able to view the messages on this board without the fraudulent messages, the name calling, and all the other garbage and nonsense on the Yahoo site.

I will probably never post any messages because my meager information pales in comparison to yours, biopearl's, cabeman's, and Irishtrader52 (as well as some others who I can't think of right this minute). The only added value I can contribute is estimates of share price based on projected sales and growth which I will provide only if a question comes up.

phil
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Joined: Wed Dec 09, 2015 2:53 pm

Re: Take aways from Oppenheimer

Post by phil » Thu Dec 10, 2015 3:01 pm

BP and FM very good posts. I agree with BP and I also took Chip's comments as almost a good thing that there were "initial" cytopenias because it was evidence that the drug was suppressing the Malignant progenitor clones. If one thinks about that it is very interesting because it really isn't an "adverse" side-effect, it's a "positive" side effect.

Also, if you go back to Ling's question during the ASH presentation where she asked about follow up data from the 3 TI patients, the Geron speaker said two important things: All three were still in trial as of December- that's 7 additional months, and he also mentioned that their respective "number of weeks of consecutive TI" might turn out to be higher. Why is this so important? Because, the time window of TI resets as soon as a patient gets a transfusion- it resets to week 0- and all had reset as he explained. So, any patient that EXCEEDS the reports time frame means that they got 1 or 2 transfusions and then went another long, extended period of time without another. Normally drugs start losing efficacy, but here, the drug might actually be getting a deeper, more positive response.

Thoughts?
Phil

Fishermangents
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Re: Take aways from Oppenheimer

Post by Fishermangents » Thu Dec 10, 2015 3:43 pm

Phil: agree with your observation. Dr. Scarlett didn't become too frenzy about it, probably because formally TI is not primary end point. But he clearly stated that they will measure everything they could in order to indicate the depth and nature of the responses. Clearly TI is a major one, in fact much more relevant than the formal end points of the trial. Anemia in MDS is particularly difficult to treat and is a major cause of death (directly or indirectly).

GenerousGeron
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Re: Take aways from Oppenheimer

Post by GenerousGeron » Thu Dec 10, 2015 4:11 pm

Just joined. Glad to me away from YMB. I never commented over there. I am a small investor in GERN and have only been invested since last year. I Believe in the science and feel comfortable that in the long run, the science will win out and the PPS will go up. Surprised at the short term pps struggle and all the shorting activity but with a longer term horizon things will work out. I invested in LGND several years ago because of their science and I think Gern will also finally win. Good luck to all.

Fishermangents
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Re: Take aways from Oppenheimer

Post by Fishermangents » Wed Jan 06, 2016 9:29 pm

Hi Generous, thanks for joining! Things in early biotech go slow for a long time, and when proven succesful things can change very quickly. For over a year now we have only good news and confirmations that imetelstat is safe and effective. The shorting of GERN is immense. Good news (e.g. fast track, good IMerge part 1 results, JnJ continuation decission etc.) can suddenly put an end to that, as real cash will come in from the milestone payments and FDA approval will be getting very realistic. Remember: JnJ anticipates for approval in 2017!

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