Lisata Therapeutics Announces Enhancements to Ongoing Phase 2b ASCEND Trial of LSTA1
BASKING RIDGE, N.J., May 24, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today 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 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 trial is fully funded by Lisata through an unrestricted research support agreement.
- “We are excited to announce the enhancements to the ASCEND trial design, including the addition of a second cohort for the evaluation of a second dose of LSTA1 in patients with mPDAC.