New Drug Delivery Trial Offers Hope for Pancreatic Cancer Patients

CARY, N.C. and BRADENTON, Fla. – May 20, 2026 – In a significant step toward addressing one of oncology's most formidable challenges, clinical-stage biotechnology company Continuity Biosciences has launched a first-in-human clinical trial for a novel drug delivery platform aimed at pancreatic cancer. The study, now enrolling patients at leading U.S. medical centers, will evaluate a device that uses a mild electrical current to deliver chemotherapy directly into tumors, a technique that could potentially transform treatment for the notoriously difficult disease.

The Phase I trial (NCT07481383) is testing the company's proprietary Iontophoretic Oncology Platform (IOP) to deliver gemcitabine, a long-standing chemotherapy drug. The study is active at WVU Medicine J.W. Ruby Memorial Hospital in West Virginia and the University of Michigan's Taubman Center, representing a critical test for a technology that promises to overcome the biological barriers that have long thwarted effective treatment.

The Unyielding Challenge of Pancreatic Cancer

Pancreatic cancer remains one of the most lethal malignancies, with five-year survival rates stubbornly stuck in the low double digits. The disease is projected to become the second-leading cause of cancer-related death in the United States by 2030. A primary reason for this grim prognosis is the tumor's unique biology.

Pancreatic tumors are typically encased in a dense, fibrous tissue called a desmoplastic stroma. This stroma, combined with poor vascularization, creates a physical fortress that severely limits the ability of systemically administered drugs to penetrate the tumor in effective concentrations. As a result, even when potent drugs like gemcitabine are infused intravenously, only a fraction of the dose reaches the cancer cells.

To compensate, oncologists must use high systemic doses, which leads to debilitating side effects as the chemotherapy circulates throughout the body, damaging healthy cells. The primary dose-limiting toxicity for gemcitabine is myelosuppression—damage to the bone marrow that results in low counts of white blood cells, red blood cells, and platelets. This can lead to increased risk of infection, anemia, and bleeding, often forcing doctors to reduce dosages or pause treatment, further compromising efficacy.

"Pancreatic cancer remains one of the most difficult cancers to treat, and patients urgently need better options," said Jen Jen Yeh, MD, Director of the Pancreatic Cancer Center of Excellence at the University of North Carolina Lineberger Comprehensive Cancer Center. "Approaches that effectively deliver therapy precisely to the tumor while sparing the rest of the body could meaningfully change outcomes for patients."

A Targeted Strike: How the IOP Platform Works

Continuity Biosciences aims to bypass these fundamental obstacles with its Iontophoretic Oncology Platform. The technology is based on iontophoresis, a well-established scientific principle that uses a low-level electrical field to drive charged drug molecules across biological tissues. The IOP device is designed to be placed near the tumor, where it can deliver gemcitabine directly into the cancerous mass.

By creating an electrical potential, the platform actively pushes the chemotherapy through the dense stromal barrier, a feat that passive diffusion from the bloodstream struggles to achieve. The goal is twofold: dramatically increase the drug concentration where it's needed most—inside the tumor—while keeping systemic levels in the bloodstream exceptionally low. This approach could theoretically maximize the cancer-killing power of gemcitabine while minimizing its toxic side effects.

"This first-in-human study represents an important milestone in our mission to transform how therapies are delivered to solid tumors," said Ramakrishna "Krishna" Venugopalan, Chief Executive Officer of Continuity Biosciences. "By enabling precise, localized delivery, we believe our platform has the potential to enhance the effectiveness of existing therapies and serve as a foundation for combination treatment approaches across multiple tumor types."

This strategy of localizing treatment represents a significant paradigm shift from the conventional "carpet bombing" approach of systemic chemotherapy. If successful, it could make existing drugs more effective and better tolerated, potentially re-establishing their utility in an era of highly targeted therapies.

The Clinical Path Forward

The newly initiated Phase I trial is designed primarily to assess the safety and tolerability of the IOP device when delivering gemcitabine to patients with non-metastatic, locally advanced pancreatic cancer that cannot be removed by surgery. Investigators will closely monitor for any adverse events related to the procedure and the localized drug delivery.

Secondary goals are equally critical. Researchers will measure the pharmacokinetics—the concentration of gemcitabine in the blood—to confirm that the system is indeed minimizing systemic exposure. They will also assess the tumor's response to the targeted treatment.

The principal investigators at the participating sites underscored the trial's importance. "This trial is a critical step toward safer, more effective delivery of gemcitabine for pancreatic cancer patients," said Brian Boone, M.D., a surgical oncologist at the WVU Cancer Institute. "By targeting therapy directly to the tumor, we hope to improve outcomes while reducing the side effects that so often limit treatment in advanced disease."

Dr. Benjamin Ferguson, M.D., PhD, a surgical oncologist at the University of Michigan Medical Center, echoed this sentiment. "One of the central challenges in treating pancreatic cancer is getting enough drug into the tumor without harming the rest of the body," he stated. "This study will tell us whether targeted, localized delivery can overcome that barrier for gemcitabine and potentially open the door to better treatment strategies for patients with limited options."

Beyond a Single Tumor: A Platform for the Future

While pancreatic cancer is the initial focus, Continuity Biosciences views its IOP as a versatile platform with broad applications. The company is already exploring its use for delivering carboplatin, another common chemotherapy, in oral head and neck cancers. This suggests a broader strategy of creating a new category of treatment where the delivery method, not just the drug itself, becomes a key part of precision oncology.

The company, which is backed by over $11 million in venture funding and recently acquired oncology device firm Focal Medical, is positioning itself at the forefront of a growing movement in cancer research. Scientists worldwide are investigating novel delivery methods, from drug-encapsulating nanoparticles to tumor-homing peptides, all aimed at solving the central problem of getting the right drug to the right place at the right concentration.

Continuity's iontophoretic approach is a distinct entry in this competitive field, leveraging electronics to physically drive therapeutics into resistant tumors. If the Phase I trial demonstrates that the IOP is safe and can successfully alter the concentration dynamics of gemcitabine, it could validate a powerful new tool in the oncological arsenal and offer a tangible glimmer of hope for patients battling one of medicine's most intractable cancers. The results of this study will be closely watched by clinicians, researchers, and patients alike, as they may signal a new direction in the long fight against solid tumors.