AUSTIN, Texas--(BUSINESS WIRE)--PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, today announced the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for the company’s lead program, PTM-101, to proceed in a phase 1b clinical study in patients with pancreatic ductal adenocarcinoma (PDAC).

“Receiving FDA clearance for our phase 1b study of PTM-101 marks a pivotal achievement for PanTher and represents a significant milestone in our mission to transform clinical outcomes for patients with challenging pancreatic cancer diagnoses”

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This phase 1b dose escalation / dose expansion study will be conducted across multiple sites and will enroll patients who have treatment naïve, borderline resectable and locally advanced PDAC, offering the potential to improve therapeutic response for those with limited treatment options.

“Receiving FDA clearance for our phase 1b study of PTM-101 marks a pivotal achievement for PanTher and represents a significant milestone in our mission to transform clinical outcomes for patients with challenging pancreatic cancer diagnoses,” said Laura Indolfi, PhD, Chief Executive Officer, and co-founder of PanTher Therapeutics. “This study will build upon the company’s positive, early clinical data in patients with borderline resectable and locally advanced PDAC. PTM-101 was developed using PanTher’s Sagittari™ drug development platform, which creates products that provide continuous delivery of high drug concentrations exclusively at the tumor site for an extended period of time. This novel approach, which maximizes killing of tumor cells, has not previously been possible with other technologies.”

Earlier this year, PanTher presented positive first-in-human data in small phase 1 study of three pancreatic cancer patients treated with PTM-101. Two of the three patients who received the lowest dose of PTM-101 followed by standard of care chemotherapy had a >40% reduction in overall tumor volume. PTM-101 was 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 in the pancreas in all patients, with no detection of systemic paclitaxel at any timepoint.

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 the creation of products that can provide continuous, high-dose treatment of potent oncology agents exclusively at the site of a tumor. This revolutionary technology allows therapeutic agents to be formulated in a wide range of polymer-based 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 Sagittari™ platform technology in additional solid tumor indications. For more information, visit www.panthertx.com.

About PTM-101

PanTher’s lead clinical product, PTM-101, is a proprietary flexible absorbable film that enables continuous, high-dose administration of paclitaxel directly to the peritumoral area, maximizing anti-tumor potency and limiting 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.

Contacts

Media:
Christine Quern
617-650-8497
cq@christinequern.com

Source: Businesswire