Phase 2 Trial for Metastatic Pancreatic Cancer Begins with First Patient Treated

A clinical-stage pharmaceutical company, Lisata Therapeutics, is collaborating with Qilu Pharmaceutical, a prominent pharmaceutical firm in China, to advance the treatment of advanced solid tumors and other severe diseases. Lisata's lead product candidate, LSTA1, is being combined with standard chemotherapy in a Phase 2 trial for metastatic pancreatic ductal adenocarcoma (mPDAC) patients in China. This trial is a significant milestone in the development of innovative therapies for this aggressive disease.

LSTA1 is an experimental drug designed to activate a new pathway that enhances the penetration of co-administered anti-cancer drugs into solid tumors. The drug is administered intravenously and is being tested alongside nab-paclitaxel and gemcitabine, which are part of the standard chemotherapy regimen for mPDAC. The trial, which is expected to last for approximately 30 months, will involve 120 patients and aims to assess the safety and efficacy of LSTA1 in combination with standard chemotherapy.

The Chief Medical Officer of Qilu, Dr. Xiaoyan Kang, has expressed optimism about the potential of LSTA1, citing promising data from a completed Phase 1 trial. The trial showed that LSTA1 could be a safe and effective treatment for mPDAC, a disease with increasing incidence and prevalence in China. Dr. Kang emphasized Qilu's commitment to working with Lisata to bring the benefits of LSTA1 to Chinese patients.

Lisata's Executive Vice President of R&D and Chief Medical Officer, Dr. Kristen K. Buck, highlighted the urgent need for new therapies for mPDAC, which often leads to poor patient outcomes despite recent advances in cancer treatment. She noted that the enrollment of the first patient in the Phase 2 trial is a significant step towards improving the lives of patients with pancreatic cancer globally.

Preliminary data from the Phase 1b/2 trial indicated a median overall survival of 11.1 months for patients treated with LSTA1 in combination with nab-paclitaxel and gemcitabine. This is in line with data from an Australian Phase 1 trial, which reported a median overall survival of 12.8 months.

LSTA1 is based on Lisata’s CendR Platform® Technology, which has shown potential to enhance the delivery of various emerging anti-cancer therapies, including immunotherapies and RNA-based treatments. The drug has demonstrated favorable safety and tolerability in clinical trials and is being evaluated for its ability to improve the effectiveness of standard chemotherapy for pancreatic cancer.

Qilu Pharmaceutical, with its extensive pipeline of novel therapeutics and a strong presence in the pharmaceutical industry, is dedicated to transforming scientific innovation into healthcare solutions. The company has a global network of R&D centers and has launched numerous products, reflecting its commitment to addressing unmet medical needs.

Lisata Therapeutics is focused on the discovery, development, and commercialization of innovative therapies for advanced solid tumors and other major diseases. The company has established partnerships and expects to achieve several clinical study and business milestones in the coming years.

The collaboration between Lisata and Qilu represents a significant effort to address the unmet medical needs of mPDAC patients and to develop new treatment options that could potentially improve patient outcomes.