Lisata Therapeutics, Inc. (Nasdaq: LSTA) is continuing their ASCEND trial, aPhase 2b trial investigating their investigational drug, LSTA1, when paired with the standard-of-care gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.
With the objective to replicate the positive results from the Phase 1b/2a open label study, the amended protocol seeks to optimize the dose and establish effect size for a potential Phase 3 study. Now, with the additional cohort, Cohort B, to assess an extra dose of LSTA1 given 4 hours after the initial dose plus SOC, a better understanding of its efficacy and patient outcomes is being sought.
The ASCEND clinical trial is a groundbreaking, 155-patient long, Phase 2b trial which was created with the collaboration of up to 40 sites located in Australia and New Zealand. This revolutionary trial is being conducted by the Australasian Gastro-Intestinal Trials Group (“AGITG”) with the support of the University of Sydney and the National Health and Medical Research Council (“NHMRC”) Clinical Trial Centre (“CTC”) acting as the Coordinating Centre.
Test results from the trial should be released during the third quarter of 2023 and enrollment is scheduled to be completed during the second quarter of 2024, although the current enrollment exceeds 50% of the target. The study has the potential to profoundly impact the future of cancer treatment, as the experimental arm of the study has an 80% power rate with 95% confidence of detecting a 16% increase in 6-month progression free survival.
We are thrilled to announce that the ASCEND trial design has been enhanced to include a second cohort for the assessment of a second dose of LSTA1 in patients with mPDAC. The results from this trial will be employed to design a powerful Phase 3 program and to explore potential conditional approvals globally.
Despite significant advancements in understanding and treating pancreatic cancer, there is still an urgent need for new treatments like LSTA1. We are proud to be collaborating with AGITG and CTC, two preeminent clinical trial groups in Australia and New Zealand, to develop and assess this promising potential treatment for patients desperately in need of help.
About LSTA1
LSTA1 is an investigational drug with extraordinary potential to transform cancer treatment. It works by activating a novel uptake pathway to get co-administered or tethered anti-cancer drugs more efficiently into solid tumors. Studies have showed that LSTA1 enhances delivery of a range of anti-cancer therapies such as chemotherapeutics, immunotherapies, and RNA-based therapeutics.
On top of that, LSTA1 has shown favorable safety, tolerability and activity in clinical trials, even when it comes to improving standard-of-care chemotherapy for pancreatic cancer. Thanks to its potential, LSTA1 could enable a variety of treatment modalities to effectively treat a range of solid tumors.
About Lisata Therapeutics
Lisata Therapeutics is on a mission to discover, develop and commercialize life-saving therapies for advanced solid tumors and other major illnesses. Through its innovative CendR Platform® Technology – the foundation of LSTA1, the company’s leading product candidate – Lisata is activating a novel uptake pathway designed to selectively target and penetrate into solid tumors with heightened potency. With several major milestones anticipated in the next 2 years, funded by existing capital, Lisata Therapeutics looks to truly revolutionize the way we treat cancer and other serious illnesses.
About the AGITG
The AGITG has been striving for almost three decades to improve the treatment and outcomes of GI cancer. With the help of multi-disciplinary teams of experts from across Australia and New Zealand, plus 125 sites around the world, 8,800 patients have participated in the 74 GI cancer clinical trials undertaken by the AGITG since 1991. It’s an ambitious mission that’s making a real difference to the lives of those affected by gastro-intestinal cancer.
About the University of Sydney
Founded in 1850, the University of Sydney is Australia’s oldest university and has shaped generations of global leaders who are passionate about making positive real-world change. We are a renowned teaching and research institution that brings together the expertise of brilliant minds from diverse backgrounds and disciplines to provide life-changing research and education.
About the NHMRC Clinical Trials Centre, University of Sydney
At the University of Sydney, the NHMRC Clinical Trials Centre is transforming healthcare. Our team of experts provides an array of services to design and manage clinical trials, from coordinating the trial and monitoring data to utilizing biostatistics for statistical analysis and review.
Not only that, but our team also helps healthcare providers identify best practices through data acquisition and management, allowing for improved decision-making. Join us in our mission to revolutionize healthcare today!
Forward-Looking Statements
Lisata recently completed a Merger, and now, the company is aiming for long-term success! But this isn’t guaranteed – several risks and uncertainties could still derail the path forward. Depending on the decisions of regulatory authorities, the duration and impact of delays, the ability to finance operations, and scientific progress, the success of Lisata as a business could look totally different from our initial projections.
On top of that, the ongoing COVID-19 pandemic brings extra challenges, meaning that it’s really difficult to predict Lisata’s success with certainty. Although this isn’t a guarantee, Lisata is striving to move forward and is hopeful that our objectives – from our capital structure and ownership to our therapeutic discovery and development – can be achieved.