Lisata, Qilu announce first patient treated in Phase 2 trial of LSTA1

Lisata Therapeutics and Qilu Pharmaceutical announced that the first patient has been treated in Qilu’s Phase 2 trial in China evaluating LSTA1, Lisata’s lead product candidate, in combination with standard-of-care chemotherapy as a first-line treatment for metastatic pancreatic ductal adenocarcinoma. Qilu, the licensee of LSTA1 in Greater China, including Taiwan, Hong Kong and Macau, is enrolling subjects in its Phase 2 120-patient, randomized, double-blind, multi-center, placebo-controlled trial evaluating 3.2 mg/kg of LSTA1 administered as a single IV push in combination with SoC chemotherapy, nab-paclitaxel and gemcitabine, versus SoC alone in patients with mPDAC. The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow-up and data analysis and reporting. “In China, both the incidence and prevalence of mPDAC cases are on the rise. Promising data from our completed Phase 1 trial suggest that LSTA1 has the potential to be a safe and effective treatment for mPDAC,” stated Xiaoyan Kang, M.D., Chief Medical Officer of Qilu. “We are committed to working with Lisata to bring the potential clinical benefits of LSTA1 to mPDAC patients in China.”