AUSTIN, Texas--(BUSINESS WIRE)-- PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company developing high-dose, long lasting, localized treatments for cancer, today presented positive data from a first-in-human study of PTM-101, a highly potent chemotherapeutic agent (paclitaxel) combined with an absorbable polymer formulated as a flexible film, at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10^th in San Diego.

This first-in-human study enrolled three patients at a single center in Australia to assess the safety and surgical feasibility of a single, low-dose treatment of PTM-101. PTM-101 was placed directly onto the pancreas, overlying the location of the tumor using standard laparoscopic equipment as part of a disease staging assessment. Once in place over the tumor site, PTM-101 locally delivered a sustained dose of the chemotherapeutic agent over four weeks. Approximately three weeks after placement of PTM-101, all participants began standard of care therapy, which included treatment with mFOLFIRINOX.

Results of the clinical trial demonstrated that PTM-101 reduced the size of pancreatic tumors in all three patients. During the 24 weeks of the prospective phase of the study, the reduction in tumor thickness beneath PTM-101 ranged from 16% to 26%. Two patients had a significant reduction in overall tumor volume (40% and 70%). PTM-101 was also shown to have a favorable safety profile, as it was well-tolerated with no peritonitis, pancreatitis, infection, or hematological toxicity. The chemotherapeutic agent remained localized to the pancreas in all patients, with no detection of systemic paclitaxel at any timepoint.

“Historically, there have been significant clinical challenges realizing the benefits of chemotherapeutics when they are administered systemically. Maintaining a high drug concentration is limited by the route of administration as well as toxicity, which negatively impacts the effectiveness of the drug,” said Laura Indolfi, PhD, Chief Executive Officer, and co-founder of PanTher Therapeutics. “We are encouraged by the early clinical data of PTM-101 in patients with locally advanced pancreatic cancer, further validating the potential of our Sagittari™ platform to deliver high-concentrations of drug directly to the site of a tumor for an extended period of time, without commonly observed undesired side effects.”

“Use of PTM-101 to locally administer a highly potent drug, without the limitations from systemic safety and tolerability issues, offers the potential to facilitate significant improvement in patient outcomes, which is clearly needed in the treatment of pancreatic cancer,” said Charles Pilgrim, MD, PhD, Associate Professor of Surgery at the Alfred Central Clinical School at Monash University, and principal investigator of the PTM-101 phase 1 clinical trial. “The ability of PTM-101, in combination with standard of care chemotherapy, to shrink pancreatic tumors as observed in this initial study is promising. The prognosis for patients with pancreatic cancer can be particularly devastating, as it is often detected at an advanced stage, at which point there are limited treatment options. Given the trajectory for this cancer, I am very encouraged by the results from the clinical trial of PTM-101 in locally advanced cases and the ease of integrating the treatment into current clinical practice and standard laparoscopic procedures.”

PanTher presented a second poster at AACR describing the non-clinical development of PTM-101.

Both posters are available on the PanTher Therapeutics website.

About PanTher Therapeutics

PanTher Therapeutics is a clinical-stage oncology company offering transformational localized treatment of cancer. This is accomplished through its proprietary Sagittari™ platform which enables continuous, high-dose treatment of potent oncology agents exclusively at the site of a tumor. The Sagittari treatment platform is a revolutionary solution for local administration of therapeutic agents. This foundational technology was invented at the Massachusetts Institute of Technology by PanTher’s founder and CEO. Sagittari is a polymer-based system that allows therapeutic agents to be formulated in a wide range of dosage forms that can be administered to the surface of a cancerous organ or implanted directly into a tumor. The drug product is designed to continuously deliver drug for weeks or months at a desired dose level, without unwanted dose-limiting side effects. PanTher’s lead clinical candidate, PTM-101, has successfully been evaluated in a Phase 1 clinical trial in treatment naïve, localized non-metastatic pancreatic cancer patients. PanTher is exploring opportunities to utilize its platform technology in additional solid tumor indications. For more information, visit www.panthertx.com.

About PTM-101

PanTher’s lead clinical candidate, PTM-101, is a proprietary flexible absorbable film that enables sustained, high-dose administration of paclitaxel directly to the peritumoral area, maximizing anti-tumor potency and reducing the side effects typically seen with systemic administration of paclitaxel. PTM-101 was designed to easily integrate with well-established laparoscopic procedures that can be used for peritumoral placement. PTM-101 is being evaluated for the treatment of localized non-metastatic pancreatic cancer, where the company recently completed a successful phase 1 study. PanTher is now preparing to initiate a Phase 1b trial of PTM-101, to further assess safety, tolerability, and anti-tumor activity across two different dose levels.

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