On August 13, 2024 PanTher Therapeutics ("PanTher" or the "Company"), a clinical-stage oncology company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, reported 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) (Press release, PanTher Therapeutics, AUG 13, 2024, View Source [SID1234645835]).
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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.