AUSTIN, Texas — A Phase 1b clinical trial testing a new localized chemotherapy patch for pancreatic cancer has begun treating patients, according to PanTher Therapeutics.
The investigational therapy, PTM-101, is an absorbable thin film containing the chemotherapy drug paclitaxel. Designed to be placed directly onto the tumor, it delivers a sustained, high-dose treatment over six weeks with minimal systemic exposure.
The first patient was treated at Virginia Mason Medical Center in Seattle, Washington, under the care of Drs. Vince Picozzi and William “Scott” Helton. Additional sites enrolling patients include Northwell Health’s Zuckerberg Cancer Center in New York, Hoag Memorial Hospital Presbyterian in California, and the Barbara Ann Karmanos Cancer Institute in Michigan. The study aims to enroll about 30 treatment-naïve patients.
“PTM-101 is a novel, innovative approach to treating the primary pancreatic tumor,” said Dr. Picozzi, a medical oncologist and principal investigator. “Doing so successfully is the first step towards curative therapy.”
The ongoing open-label trial is evaluating PTM-101 in combination with standard neoadjuvant chemotherapy (FOLFIRINOX) for patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). It follows a previous first-in-human study in which PTM-101 showed promising tumor shrinkage and no detectable systemic paclitaxel levels.
“Powerful cancer drugs exist but their toxicity lowers maximum dose and limits dosing frequency — leaving too many opportunities for cancers to continue spreading while patients grapple with debilitating side effects,” said Laura Indolfi, Ph.D., CEO and co-founder of PanTher Therapeutics. “Our investigational formulations are designed to circumvent the toxic effects of systemic chemotherapy while retaining a much higher dose of the drug exclusively at the tumor.”
Systemic chemotherapy typically delivers only about 1% of the drug to the tumor, with the rest absorbed by healthy tissues, often causing harmful side effects like nausea, neuropathy, and neutropenia. Localized delivery aims to overcome this issue, particularly in pancreatic cancer, which is poorly vascularized and difficult to treat effectively with systemic drugs.
“The ability of PTM-101 to integrate into our current PDAC care pathway is promising,” said Dr. Helton, a pancreatic surgeon. “It offers the possibility of transforming a diagnostic step into the start of therapy, weeks before the patient can begin intravenous chemotherapy.”
PanTher is also exploring similar drug delivery methods for other types of solid tumors.
