The Ozempafying of IMprove

[biopearl123]

IMprove just got slimed down, two institutions withdrawn and anticipated number of enrolled reduces from 50s to 36. Back to straight Rux combo:

Drug: Pacritinib
Pacritinib will be administered once daily (QD) or BID in cohort B as the standard of care per local prescribing guidelines.

Drug: Momelotinib
Momelotinib will be administered once daily QD in cohort B as the standard of care per local prescribing guidelines.

Drug: Fedratinib
Fedratinib will be administered QD in cohort B as the standard of care per local prescribing guidelines.

Pacritinib,Monelotinib, Fedratinib, eliminated from study. Also eliminated from study is company contact Shamalaya who may have been a casualty of the Ozempafying of the employee roster.

Interesting addition of focus on time to development of AML. Malignant clone reduction? By the way anyone been able to figure out if Faye is still in the picture?

I am not sure what to make of this but it seems that early clinical results might be good enough to move to a PII, thoughts?

[biopearl123]

Additionally, the study previously had endpoint of TSS, Spleen, OS and now specifically splits out time to development of AML. Make of that what you will.

[biopearl123]

Also note floor for allowable platelet count dropped from 100k to 75k.

[Hoosier Investor]

I see the CT update/changes as a positive.

It's a Geron sponsored trial, and it appears they're moving it along....for the sake of cost savings & completion time. Don't waste time & money studying other JAK inhibitors (besides RUX), no longer recruiting/requiring Part A, opening the enrollment up via platelet count, etc. The changes appear to align with the "let's get on with it" attitude of our new management.

FYI...The new AML trial is an Investigator Sponsored Trial (IST). Similarly, a move forward with an investigator that has an interest...with consultation and drug supply (minimal expense) from Geron's side. Another positive in my opinion.

[biopearl123]

HI, hope you are well and enjoying the new year. I agree on all points. The IST has an extraordinarily long time line!! What do you make of that? I actually can't find platelet count as an exclusion any more in the part B part of the clinical trial description.