Replies to post #10040 on Pluristem Therapeutics Inc (PSTI)

[Spideyboy]

Thanks for finding this.

Leukine is pure yeast derived recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) that functions as an immunostimulator.

So again like EC-18, only works on 1 cell line (neutrophils) of the 3 that R18 and Entolimod work on.

Very little information about this drug in ARS, and can't find any clear NHP data about it.

For information about the drug, here's a comprehensive view, but admittedly a bit ugly.
https://www.rxlist.com/leukine-drug.htm

While there is no information about Leukin in ARS, we can still look at the totality of the data provided across the different indications, cancer and bone marrow transplant.
The clearest information I think is pertinent can be found in 'Table 1: Hematological Recovery (in Days): Induction'

And with the accompanying text.

"LEUKINE significantly shortened the median duration of [Absolute Neutrophil Count] ANC <500/mm3 by 4 days and <1000/mm3 by 7 days following induction (see Table 1)" As expected from and immunostimulator.

"Median times to platelet (>20,000/mm3) and RBC transfusion independence were not significantly different between treatment [and placebo] groups."

"During the consolidation phase of treatment, LEUKINE did not shorten the median time to recovery of ANC to 500/mm3 (13 days) or 1000/mm3 (14.5 days) compared to placebo. There were no significant differences in time to platelet and RBC transfusion independence."

The data shows the p values for Platelet and RBC are way off target.

Also, again while not on ARS.

"Survival studies comparing mobilized study patients to the nonmobilized patients and to an autologous historical bone marrow transplant group showed no differences in median survival time"

"LEUKINE-treated patients also had a shorter median duration of post-transplant IV antibiotic infusions, and shorter median number of days to last platelet and RBC transfusions compared to placebo patients, but none of these differences reached statistical significance."

Also this product needs to be given every day for it to have its effect, so not useful in a mass casualty scenario.

"White cells: Both G-CSF (filgrastim, pegfilgrastim) and GM-CSF (sargramostim [Leukine]) are available, and may reduce the level and duration of neutropaenia. Pegfilgrastim has the advantage of being given once every 3-5 days rather than daily, making it more suitable for mass casualty use. Note that G-CSF may be inhibitory to megakaryocytes and can prolong thrombocytopaenia. "
http://www.health.gov.au/internet/publications/publishing.nsf/Content/ohp-radiological-toc~ohp-radiological-20-app-e

R18 by comparison needs two shots, with 4 days between those two shots.

All this together, does not appear to make this something worth worrying about, compared to R18 and Entolimod. Also note that if this were to have great potential in ARS, wouldn't Sanofi have followed suit?