Just for fun while we wait, a repost from SA

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biopearl123
Posts: 210
Joined: Fri Jul 20, 2018 5:13 pm

Just for fun while we wait, a repost from SA

Post by biopearl123 » Sun Jul 07, 2019 11:30 pm

Reposted from SA:

Here's a long shot. As the final protocol becomes public soon and since we know the PIII design will not change much if at all, this nagging "proprietary" study design hinted at by Scarlett has been tugging at me. Is it possible that there will be a "Secret Third Arm" (in honor of Bridge)? This secret third arm would use RWD with matched controls to compare with the actual not secret second arm of placebo to validate this RWD data approach such that the need for placebo groups in future studies might be minimized? I doubt it would really be secret but just part of the PIII protocol since it be public record and the historical controls are already out there so it shouldn't affect the timeline of the study but just add a potential validation to approaches already suggested by the last MF EHA presentation. Bridge, tell the truth, did you see this coming when you chose your other moniker? If so kudos, if not it might be a great harbinger of things to come. Regards, bp

esf1950
Posts: 2
Joined: Tue May 28, 2019 3:52 am

Re: Just for fun while we wait, a repost from SA

Post by esf1950 » Mon Jul 15, 2019 9:04 am

while reading your postthe woprds "proprietyary study" design hinted at could be related to this study..
https://patents.justia.com/patent/20180036336 note under brief summary of the invention...
The combined dosing of imetelstat sodium and ABT-199 in AML cells provides a novel treatment for hematologic cancers and specifically AML. Imetelstat sodium is currently being investigated clinically in myeloid fibrosis (MF) and myelodysplastic syndrome (MDS). ABT-199 is FDA approved in CLL and is also being investigated in AML. ths implies that imetelstat is currently being studied with ABT-199 in combination for AML..If correct and currently ON GOING then this is HUGE...

esf1950
Posts: 2
Joined: Tue May 28, 2019 3:52 am

Re: Just for fun while we wait, a repost from SA

Post by esf1950 » Mon Jul 15, 2019 9:04 am

while reading your postthe woprds "proprietyary study" design hinted at could be related to this study..
https://patents.justia.com/patent/20180036336 note under brief summary of the invention...
The combined dosing of imetelstat sodium and ABT-199 in AML cells provides a novel treatment for hematologic cancers and specifically AML. Imetelstat sodium is currently being investigated clinically in myeloid fibrosis (MF) and myelodysplastic syndrome (MDS). ABT-199 is FDA approved in CLL and is also being investigated in AML. ths implies that imetelstat is currently being studied with ABT-199 in combination for AML..If correct and currently ON GOING then this is HUGE...

biopearl123
Posts: 210
Joined: Fri Jul 20, 2018 5:13 pm

Re: Just for fun while we wait, a repost from SA

Post by biopearl123 » Mon Jul 15, 2019 6:18 pm

esf, great thought but there could be no combo therapy trials in patients without FDA approval but there is some likelihood that research continues in the lab with various combination therapies. bp

Secret Third Arm
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Joined: Tue Aug 28, 2018 3:26 pm

Re: Just for fun while we wait, a repost from SA

Post by Secret Third Arm » Tue Jul 16, 2019 7:18 pm

Interesting thought BP! I'm not sure if that's ever been attempted before, although I certainly see the comparative value. If nothing else, bringing such additional data to the FDA can't hurt, and the company clearly has the properly trained staff on hand to do so as seen by their approach to RWD in MF. My only hope would be that they aren't diverting resources from that MF team right now and are instead focused on building a compelling argument for the FDA meeting.

Diving a little deeper, it's been suggested that the historical MF data that Geron brings to the FDA in 1Q2020 needs to have been peer reviewed. The hope is that this will happen by way of an abstract at the 2019 ASH conference. If that is true, then any data accrued after ASH is not likely to be included since it will not have been peer reviewed.

Now remember that 2019 ASH abstracts are due in TWO WEEKS! That's right, abstract submission is due August 1st 2019. If we assume that Geron would not risk waiting until the late breaking abstract date, then it's safe to think that all the data that they (Geron) plan to bring to the FDA to support MF approval has already been compiled and an analysis is complete.

If that's true, then the team that worked on the historical MF data may have some free bandwidth to work on historical data for MDS. After all, management brought in some very heavy hitters in statistical analysis. It would be a shame to sideline them if the MF work is basically complete. Having them continue to work on MF data is a possibility, but because of the ASH embargo, there is almost no time for that data to be published and peer reviewed anywhere else. ASH is December 7-10 2019, so the window between then and the planned 1Q FDA meeting is very small.

Abstract approval happens by Oct 5, 2019 so in 81 days or less we will know if the abstract was accepted and the basic info it contains. With a large enough sample size, the historical data may be truly compelling.

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