Lisata Therapeutics Inc (NASDAQ:LSTA), a clinical-stage pharmaceutical firm specializing in innovative cancer therapies, said it has completed patient enrollment in the Phase 2b ASCEND trial for its pancreatic cancer drug candidate, LSTA1, nearly six months ahead of schedule.
The ASCEND trial, a critical initiative for Lisata, involves 155 patients and compares the standard-of-care (SoC) gemcitabine and nab-paclitaxel against SoC plus LSTA1.
LSTA1 is designed to enhance the delivery of anti-cancer drugs in solid tumors without worsening side effects.
With enrollment completed faster than expected, top-line data from the 95 patients in Cohort A is expected to be revealed in the fourth quarter of 2024.
The trial's approach involves randomizing participants 2:1 in favor of the study intervention over SoC plus placebo. Cohort A, which received a single dose of LSTA1 plus SoC, demonstrated significant improvements in both progression-free survival and overall survival in earlier trials. Cohort B will assess whether a second dose of LSTA1 enhances outcomes further.
"The completion of enrollment in ASCEND is a vital step in the development of LSTA1; exceeding the original enrollment completion expectations and, as a result, accelerating the expected timeline for seminal data by nearly 12 months,” CEO David Mazzo, said in a statement.
“We believe LSTA1 has the potential to transform the treatment landscape for this and many other devastating solid tumor cancers.”
In addition to its potential in pancreatic cancer, LSTA1 has demonstrated promising results in enhancing the delivery of various anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics. Lisata plans to explore LSTA1's potential across a range of solid tumors to make treatments more effective.
New Jersey-based Lisata is dedicated to discovering, developing, and commercializing innovative therapies for advanced solid tumors and other major diseases. The company has multiple clinical study and business milestones over the next two years, funded through early 2026.