Focal Medical Granted FDA Approval for Pancreatic Cancer Trial

A novel medical advancement aims to revolutionize the treatment of pancreatic cancer, one of the most challenging forms of cancer to combat. An innovative implantable device, ACT-IOP-003, has been developed to deliver a high concentration of the drug gemcitabine directly to the pancreas, bypassing the circulatory system and minimizing systemic drug exposure and related toxicity.

In an orthotopic patient-derived xenograft murine model, the device demonstrated remarkable efficacy, achieving an average 40% reduction in tumor volume in all treated cases. This breakthrough could potentially extend the survival of patients with nonresectable pancreatic tumors, a group that currently faces limited treatment options and a significantly poorer prognosis.

The biopharmaceutical company behind this innovation, Focal Medical, Inc., has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1b clinical trial of ACT-IOP-003. Scheduled to commence in mid-2024, the trial will focus on evaluating the safety and tolerability of the targeted delivery system for locally advanced nonresectable pancreatic tumors.

Dr. William Daunch, Chief Technology Officer at Focal Medical, highlights the significance of this development, stating that localized delivery of gemcitabine could reduce tumor size to a point where surgical removal becomes a possibility, a major advancement in the treatment of pancreatic cancer. The American Cancer Society reports that pancreatic adenocarcinoma accounts for over 90% of pancreatic cancer diagnoses and is the third leading cause of cancer-related deaths in the U.S.

The upcoming clinical trial is a multi-center, open-label study designed to assess the safety, tolerability, and clinical activity of the implantable device. It will involve two cohorts of patients, each receiving treatment once or twice weekly over a period of 8 weeks. The study aims to enroll up to 12 patients and represents a significant step forward in the fight against pancreatic cancer.

Jen Jen Yeh, M.D., a co-founder and non-executive director of Focal Medical, and a leading researcher in the field, emphasizes the need for new tools to combat this aggressive disease. The innovative approach of Focal Medical's system, which selectively targets the pancreas with gemcitabine, offers a glimmer of hope for patients with nonresectable tumors.

Michael Aldridge, CEO of Focal Medical, underscores the importance of the FDA's clearance for the company's IND application, reflecting their commitment to providing hope for patients suffering from this devastating disease. Focal Medical is dedicated to developing novel therapeutic products based on its innovative targeted therapeutic system, which has the potential to expand into therapies for other solid tumors and genomic medicine products.

The company's patented iontophoresis delivery system is a key component of its technology, enabling the direct and selective delivery of therapeutics to the target organ using non-circulatory pathways. This addresses the significant challenges of traditional systemic drug delivery, including systemic toxicity and therapeutic barriers.

As the medical community eagerly awaits the results of the Phase 1b clinical trial, the potential impact of ACT-IOP-003 on the treatment of pancreatic cancer cannot be overstated. If successful, this implantable device could change the landscape of cancer treatment, offering new possibilities for patients with nonresectable tumors and improving survival rates.