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Take away from Stifel

Posted: Wed Nov 16, 2016 2:21 pm
by Fishermangents
Dr.Scarlett speaking at the Stifel 2016 Healthcare Conference, 15 Nov 2016 at 9:30 am ET

By AnonymousWizard, SA 15 Nov 2016, 06.18 ET

'Listened to the Stifel presentation and not much really new but a sort of confirmation and some clarity. The 9.4 Arm enrollment was placed on hold because they felt they had enough 9.4 patients to run the 24 weeks in a multi-center trial to determine if the likely 9.4 dosage was going to get results. Scarlett commented that 68 patients was good math roughly 50 from originally at 9.4 plus the queued already screened patients entering at 9.4 dosage.'

Re: Take away from Stifel

Posted: Wed Nov 16, 2016 4:31 pm
by biotech_bs
A couple of other points made:
-the failure of the 4.7 arm was expected and consistent with what Tefferi observed in the pilot study.
-they don't know if 9.4 is the optimal dose but it is considered the max dose because higher doses create a more rapid change in the disease which is not good for these frail patients with very little functional bone marrow left. They need time for the bone marrow to recover. (I believe irishtrader's husband is on a dose less than 9.4)

Re: Take away from Stifel

Posted: Fri Nov 18, 2016 8:07 pm
by biopearl
BS, yes I think Irish's husband John is on 7.5 mg. It is worth noting the Scarlett also discussed CI with symptom improvement in multiple areas thus setting the table of some determination of ORR (overall response rate) data. bp

Re: Take away from Stifel

Posted: Tue Nov 22, 2016 3:18 pm
by irishtrader52
Hi Bio and Fish,

Great posts and accurate comments. Fish, your posts are always outstanding. I am grateful for the time you dedicate to it. Thank you.

Yes, it is my understanding all good behind the scenes. Why JJ does not share more information befuddles me. I can only speculate that after the 2013 undeserved seemingly organized trashing of Imet, now getting all their ducks in a row. Patience is the mother of success.

Yes, bio, John is still on 7.5 mg since he restarted imetelstat Summer 2015. We want him back on 9.4 because Mayo knows optimal dose and comparing his 15 months on 9.5 versus 15 months on 7.5 - we will take 9.4. In our experience, Imet works slower on 7.5 and creates more plateaus as well. 9.4 worked more quickly and sustains gains more consistently. The only reason John is not back on 9.4 is JJ will not approve the increase in dosage until Imbark over. He is still on 3 week regime.

However, we are so glad he is on Imet at all. Otherwise, I have no doubt he would be dead by now. He would not have qualified for Imbark because he was refractory to hydroxurea and not jakafi. Based on the jakafi research I read, and his very fragile state in 2013 (severe anemia), I did not think jakafi would do any good and would make him worse faster. It is a brutal drug and IMO cost/benefit of jakafi not in his favor so he was not jak refractory because never took it. In Mayo pilot patients, about 1/2 jak refractory and 1/2 hydroxurea refractory and it seemed to make no difference in response to Imet.

However, without Imet, he woud have probably been dead before Imbark even started. John has had intermediate high risk and then high risk with complex karotype (poor prognostic predictor) now for 5 years at least (originally misdiagnosed before Mayo). When he began Imet treatment in pilot study at Mayo in April 2013, his prognosis was 1-3 years. Since Imet cleared fibrosis in his bone marrow, he has been thriving and staying alive.

This Thanksgiving, we wish and pray for the imet miracle for all the Imbark study patients and many more to come. The same miracle that gives us another Thanksgiving with our family and the chance for "JayJay" to celebrate our only granddaughter's 3rd birthday. She was born on Thanksgiving Day 7 months after John began Imet treatment. As she grows, we are keenly aware of the gift of time given and Imet's OS potential.

We are also grateful for the investors who continue to believe and hope with us for the Imet miracle.

Happy Thanksgiving to All!

PS - We invested a small amount (for us a large amount) in Imet at peak in December 2013 to help support this drug development since we were benefiting. Need less to say, we, too, have lost a lot of $ since. But we have never sold a share and never will. We still believe. Blessings.