Lisata Therapeutics, Inc. announced protocol changes to the ongoing ASCEND trial, a Phase 2b trial evaluating LSTA1, Lisata's lead investigational drug, in combination with standard-of-care (“SOC”) gemcitabine/nab-paclitaxel in patients with first-line, metastatic pancreatic ductal adenocarcinoma (“mPDAC”). The objective of the original ASCEND trial was to confirm, in a rigorous, controlled, double-blind study, the positive results of the Phase 1b/2a open label study evaluating LSTA1 in mPDAC patients receiving one dose of LSTA1 plus SOC. The amended protocol retains this objective while adding the goals of optimizing the dose of LSTA1 in this indication and establishing effect size for a possible Phase 3 study.

The protocol amendment includes an additional cohort (Cohort B) to assess whether a second dose solely of LSTA1, administered 4 hours after the original dose of LSTA1 plus SOC, will further improve efficacy and patient outcomes. The ASCEND trial is now a 155-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastro-Intestinal Trials Group (“AGITG”) in collaboration with the University of Sydney and with the National Health and Medical Research Council (“NHMRC”) Clinical Trial Centre (“CTC”) at the University of Sydney as the Coordinating Centre. The trial is fully funded by Lisata through an unrestricted research support agreement.

ASCEND, based upon Cohort A (the group receiving a single dose of LSTA1 plus SOC), has 80% power with 95% confidence to detect a 16% increase in the 6-month progression free survival (“PFS”) rate in the experimental arm vs. the control arm (SOC + placebo). Additionally, the protocol prescribes a futility analysis to be conducted when 30 enrolled patients on the experimental arms have been followed for at least six months.

Those results, as determined by an independent data safety monitoring committee, are expected to be announced during the third quarter of 2023. Trial enrollment completion is projected for the second quarter of 2024; however, current enrollment already exceeds 50% of the target, so earlier enrollment completion may be achieved.