AGITG, NHMRC Clinical Trials Centre At University Of Sydney, And Lisata Therapeutics Announce Preliminary Cohort B Data From ASCEND Phase 2b Trial In Metastatic Pancreatic Cancer

ASCEND comprises two dosing regimens of certepetide evaluated in two separate study arms enrolled sequentially

Positive signal in progression-free survival and objective response rate observed in certepetide-treated group compared to placebo-treated group

Cohort B data corroborate Cohort A data indicating certepetide has a treatment effect and an attractive safety profile

Full study data from both cohorts expected later this year

BARCELONA, Spain, June 26, 2025 (GLOBE NEWSWIRE) -- The Australasian Gastro-Intestinal Trials Group ("AGITG"), the NHMRC Clinical Trials Centre at the University of Sydney, and Lisata Therapeutics, Inc (("Lisata", NASDAQ:LSTA), today announced promising positive preliminary Cohort B data from the ASCEND Phase 2b trial (NCT05042128) in metastatic pancreatic cancer, with AGITG sponsoring the study and Lisata providing funding. Dr. Andrew Dean, Study Chair, is scheduled to present these findings at the European Society for Medical Oncology ("ESMO") Gastrointestinal Cancers Congress in Barcelona, Spain, on 2 July, 2025.

The ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial evaluating standard-of-care ("SoC") gemcitabine and nab-paclitaxel vs SoC plus certepetide or placebo in patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"). Participants were enrolled from 24 sites across Australia and Aotearoa New Zealand from May 2022 to December 2023. The study comprises two sequentially enrolled dosing regimens of either certepetide or placebo in combination with SoC. Cohort A employed one 3.2 mg/kg dose of certepetide administered as an IV push over 1 minute immediately after the infusion of gemcitabine and before the infusion of nab-paclitaxel. Cohort B mimicked the dosing regimen of Cohort A; however, it employed an additional dose of certepetide or placebo administered 4 hours after the initial dose.

Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year, with more information to follow as it becomes available.