AUSTIN, Texas– PanTher Therapeutics has completed dosing in the first cohort of its Phase 1b trial evaluating PTM-101, an investigational chemotherapy patch for pancreatic cancer, earlier than expected. The milestone allows the study to move into its highest-dose stage with enrollment continuing at sites across the United States.
The trial is testing PTM-101, a thin film formulation of paclitaxel designed to deliver a sustained six-week, high-dose treatment directly to pancreatic tumors with minimal systemic exposure. The approach aims to overcome the limitations of intravenous chemotherapy, which struggles to penetrate solid tumors and often causes severe side effects.
In the completed 200 mg cohort, no dose-limiting toxicities were reported. The Safety Committee has now cleared dosing at the 400 mg level, and the first patient in that group has already been treated.
“The swift execution of this first stage of our Phase 1b study underscores the momentum of our clinical strategy and the promise of PTM-101 as a new treatment paradigm for pancreatic cancer,” said Laura Indolfi, Ph.D., chief executive officer and co-founder of PanTher Therapeutics. “We are encouraged by the good safety profile observed so far and excited by the strong engagement from our clinical investigators.”
Dr. Danielle DePeralta, principal investigator and surgical director of the Pancreas Multidisciplinary Program at Northwell Health Cancer Institute, said PTM-101 has been simple to incorporate into existing procedures. “Patch placement is incorporated into procedures that the patient would otherwise need prior to initiating standard systemic chemotherapy,” DePeralta said. “My hope is that targeted local treatment with the patch, paired with standard chemotherapy, will make more patients with isolated pancreatic tumors candidates for surgical removal with the goal of long-term survival and cure.”
The Phase 1b trial (NCT06673017) is assessing safety, tolerability and anti-tumor activity of PTM-101 when combined with standard neoadjuvant chemotherapy (FOLFIRINOX) in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma. Dosing has taken place at three U.S. clinical sites, with the University of Texas MD Anderson Cancer Center in Houston recently joining the study.
PTM-101 is PanTher’s lead product candidate in a pipeline of implantable medicines designed for hard-to-treat solid tumors. The company is also developing polymeric drug formulations for additional cancer types.
