Target enrollment increased to 155 subjects with the addition of a cohort testing a second dose of LSTA1
Results to be used to explore possible conditional approvals globally
Futility analysis results expected in the third quarter of 2023
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 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.
“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. We intend to use these results to design an efficient Phase 3 program and to explore possible conditional approvals globally,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. “Pancreatic cancer has one of the highest mortality rates of all cancers and affects hundreds of thousands of patients worldwide each year. Although progress has been made in understanding and treating pancreatic cancer, there remains significant unmet medical need. We are delighted to be working with AGITG and CTC, a preeminent clinical trials group in Australia and New Zealand, to develop this promising potential treatment for patients in serious need.”
About LSTA1
LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies and RNA-based therapeutics. Additionally, LSTA1 has demonstrated favorable safety, tolerability and activity in clinical trials to enhance delivery of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors more effectively.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, LSTA1, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Based on Lisata’s CendR Platform® Technology, Lisata has already established noteworthy commercial and R&D partnerships. The company projects the announcement of many clinical study and business milestones over the next 2 years, having indicated that its current business and development plan is funded with available capital through these milestones and into early 2026. For more information on the Company, please visit www.lisata.com.
About the AGITG
The Australasian Gastro-Intestinal Trials Group (AGITG) is a multi-disciplinary collaborative group that undertakes patient-centric research to advance medical care and practice in the treatment of gastro-intestinal cancer. Since 1991, the AGITG has led 74 GI cancer clinical trials, enrolling 8,800 patients across 129 hospitals in Australia and New Zealand, and 125 sites globally.
About the University of Sydney
As Australia’s first university – founded in 1850 – the University of Sydney has a proud history of global leadership in education and research and inspiring people from all backgrounds to contribute to positive real-world change. We’re a world-renowned teaching and research institution – our research combines the expertise and talents of scholars from many disciplines.
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