Pluristem Therapeutics Inc (PSTI)

[FDApproved]

RESULTS POSTED ! VERY GOOD RESULTS ! Sunday, December 2, 2018, 6:00 PM-8:00 PM Hillard M Lazarus, MD


Case Western Reserve University School of Medicine, Cleveland, OH

Results:


Results: Cohort 1 (low-dose) - 3 subjects (ages 43, 48 and 55 years old) who had an Allo (n=2) or Auto (n=1) HCT received two IM administrations of PLX-R18, 1 million cells/kg each within a 1-week interval. 67 Adverse Events (AEs) were recorded. 64.3% of the AEs were grade 1, 30.9% were grade 2, 3.6% were grade 3 and 1.2% were grade 4. One patient suffered from 3 Serious AEs (immune thrombocytopenic purpura, bacteremia and migraine), all assessed as not related to treatment. Most frequent related AE was transient injection site pain, experienced by all 3 patients. See patients’ details and blood counts in the table and graphs.



Conclusions: Treatment with PLX-R18 generally was well-tolerated and most frequent adverse events were injection site reactions, which were all reversible without sequelae. The trial continues to accrue patients and the next dosing cohort (intermediate dose) is at 2 million cells/kg.

Upon completion, a larger phase II trial will be considered in the same indication using the optimal dose. Other potential uses include PLX-R18 therapy in Acute Radiation Syndrome, Bone marrow failure, and in HCT as a "pan" cytokine for rapid count recovery.


https://ash.confex.com/ash/2018/webprogram/Paper116239.html