PSTI (TASE: PLTR) had positive 12-month data from its P1 open-label, dose-escalation clinical trials.
- The endpoints of these P1 trials included data on tumorigenesis, adverse events, immunological reactions, laboratory and ECG findings. The results of these 2 trials were combined for reporting purposes;
- No malignancies were reported and all serum sample levels of tumor markers (PSA, CEA, CA125, AFF and NSE) were within normal range for all patients tested. Monitoring for malignancies was required only in the clinical trial conducted in Germany. It was concluded that treatment with PLX-PAD cells does not induce tumorigenesis;
- No clinical evidence of adverse events or toxicities related to the intramuscular (NYSE:IM) administration of PLX-PAD cells was observed in twenty-six of twenty-seven patients. Only one patient in the US trial experienced a transient local cutaneous inflammation after PLX-PAD was administered;
- A transient change was noted in the leukocyte and lymphocyte count in the patients, which returned to pre-injection baseline levels within 7 days and without evidence of absolute lymphopenia. No ECG abnormalities were detected during the treatment and monitoring periods.
The Bottom Line: PLX-PAD cells met all the clinical studies’ protocol endpoints, demonstrating a safe immunologic profile at all dosage levels and found to be potentially effective in treating patients suffering from Critical Limb Ischemia (CLI). There were no significant safety issues and PLX-PAD cells can be safely given IM to patients without matching, even if the patients are dosed 2X from the same placental source. 5 of the 27 patients received a double dose of PLX-PAD cells from the same placental batch two weeks apart without evidence of adverse events.