Complete enrollment achieved nearly six months ahead of plan
Top-line data now anticipated mid-2025
Addition of second-line cholangiocarcinoma arm to BOLSTER trial
BASKING RIDGE, N.J., July 16, 2024 (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, announced today the early completion of enrollment in its Phase 2a BOLSTER trial evaluating certepetide (formerly LSTA1), Lisata's investigational product, as a treatment for first-line cholangiocarcinoma ("CCA"). This key milestone comes nearly six months sooner than originally expected.
The BOLSTER trial is a Phase 2a double-blind, placebo-controlled, multi-center, randomized study evaluating certepetide in combination with standard-of-care (gemcitabine/cisplatin/durvalumab) versus standard-of-care alone in patients with first-line CCA in the United States. The rapid enrollment of this cohort underscores the urgent need for new treatment options for patients with CCA, a difficult-to-treat solid tumor with a poor prognosis. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in second-line CCA, Lisata has added an arm to the BOLSTER trial evaluating second-line CCA. The Company expects to enroll the first patient in the second-line CCA arm by the fourth quarter of 2024.