Lisata Therapeutics Reaches Key Milestone in CENDIFOX Trial

Lisata Therapeutics Achieves Significant Milestone in CENDIFOX Trial

Lisata Therapeutics, Inc. (NASDAQ: LSTA), a dynamic clinical-stage pharmaceutical company, proudly announces the successful completion of patient enrollment in its CENDIFOX trial. This Phase 1b/2a trial, spearheaded by Dr. Anup Kasi at The University of Kansas Cancer Center, focuses on assessing the innovative iRGD cyclic peptide product candidate, certepetide, in conjunction with FOLFIRINOX-based therapies aimed at treating pancreatic, colon, and appendiceal cancers.

The Importance of CENDIFOX Trial Enrollment Completion

Kristen K. Buck, M.D., Executive Vice President of Research and Development at Lisata, emphasizes the significance of this milestone, stating, "The successful enrollment of all three cohorts in the CENDIFOX trial is another notable achievement that brings us closer to validating certepetide’s transformative potential. We are committed to addressing the urgent medical needs of patients suffering from advanced solid tumors and improving their treatment outcomes. We are excitedly looking forward to reporting vital results from this study."

Trial Overview and Objectives

The CENDIFOX trial is designed as an open-label study that evaluates the safety and efficacy of combining certepetide with neoadjuvant FOLFIRINOX regimens, with or without the addition of panitumumab. Conducted exclusively at the KU Cancer Center, the trial successfully enrolled 66 participants, categorized into three cohorts: 35 patients with resectable and borderline resectable pancreatic cancer, 18 patients with high-grade colon and appendiceal cancer with peritoneal metastasis, and 13 patients with colon cancer showcasing oligo-metastatic disease. This careful structure of the trial allows Lisata to gather crucial data for immune profiling both before and after treatment, and provides long-term information regarding patient outcomes.

Insights from the Principal Investigator

Dr. Anup Kasi, the Principal Investigator for the study, shares his enthusiasm about the trial's progress, stating, "We are delighted to complete enrollment across all cohorts in the CENDIFOX study. The encouraging results from the administration of certepetide have the potential to significantly improve the prognosis for patients dealing with advanced solid tumors. We are eager to analyze cohort data to assess the efficacy of this promising therapy."

Understanding Certepetide and Its Mechanism

Certepetide is an investigational internalizing RGD, or arginylglycylaspartic acid, cyclic peptide that has been designed to selectively activate active transport mechanisms, thereby enabling co-administered therapeutic agents to penetrate and accumulate in targeted tissues more effectively. Previous studies of certepetide have indicated positive safety profiles, tolerability, and clinical efficacy in both completed and ongoing oncology trials, confirming its capacity to enhance the effectiveness of standard chemotherapy regimens for pancreatic cancer and potential for use in various other solid tumor fields.

Certepetide's Designations and Potential

With notable recognition from regulatory bodies, certepetide has received Fast Track designation and Orphan Drug Designation for pancreatic cancer in both the U.S. and E.U. Furthermore, it has attained Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma in the U.S., along with a Rare Pediatric Disease Designation for osteosarcoma. This broad range of designations reflects its promising therapeutic potential across a spectrum of challenging diseases.

A Glimpse into Lisata Therapeutics

Lisata Therapeutics is committed to revolutionizing the treatment landscape for advanced solid tumors. As a clinical-stage pharmaceutical company, Lisata is engaged in the discovery, development, and commercialization of innovative therapies, notably focusing on their iRGD cyclic peptide product candidate, certepetide. Already, Lisata has formed strategic commercial and R&D partnerships linked to its groundbreaking CendR Platform technology. The company aims to reach significant milestones in the near future, supported by funding projected to sustain operations into early 2026.

Collaboration with the University of Kansas Cancer Center

The collaboration with the University of Kansas Cancer Center epitomizes Lisata's dedication to advancing cancer care through innovative drug discovery and comprehensive patient care. This partnership will help drive forward-thinking research that bridges scientific inquiry with tangible therapeutic advancements.

Frequently Asked Questions

What is the CENDIFOX trial?

The CENDIFOX trial is an innovative Phase 1b/2a clinical study evaluating the combination of certepetide with FOLFIRINOX-based therapies for patients with advanced solid tumors, including pancreatic, colon, and appendiceal cancers.

What are the main objectives of the CENDIFOX trial?

The trial aims to assess the safety and efficacy of combining certepetide with chemotherapy regimens, along with collecting valuable pre- and post-treatment data to understand patient outcomes.

Who is leading the CENDIFOX trial?

The trial is led by Dr. Anup Kasi at The University of Kansas Cancer Center, who is exploring the potential benefits of the treatment on patient health outcomes.

What designations has certepetide received?

Certepetide has received Fast Track designation, Orphan Drug Designations for various cancers, and Rare Pediatric Disease Designation for osteosarcoma in the U.S.

How does Lisata Therapeutics plan to advance its research?

Lisata Therapeutics is committed to substantial R&D endeavors and strategic partnerships, anticipating to announce significant milestones and progress in its ongoing and upcoming clinical trials in the near future.

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