paclitaxel sustained release (PTM-101) / PanTher - LARVOL DELTA

PanTher Completes First Cohort in Pancreatic Cancer Phase 1b Trial Ahead of Expectations (Businesswire) - "PTM-101 administration in the 200 mg cohort has been completed without dose-limiting toxicity."

Trial status • Pancreatic Ductal Adenocarcinoma

PanTher Initiates Phase 1b Clinical Trial of Absorbable, Long-Lasting, High-Dose Chemotherapy Patch for Pancreatic Cancer (Yahoo Finance) - "PanTher Therapeutics...announced that the first patient has been treated with PTM-101 in a Phase 1b clinical trial in pancreatic ductal adenocarcinoma (PDAC)."

Trial status • Pancreatic Ductal Adenocarcinoma

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: PanTher Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: PanTher Therapeutics

Metastases • New P1 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

PanTher Therapeutics Receives FDA Clearance of IND Application for Phase 1b Study of PTM-101 for the Localized Treatment of Pancreatic Cancer (Businesswire) - "PanTher Therapeutics...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). 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."

IND • New P1 trial • Pancreatic Ductal Adenocarcinoma

First-in-human phase 1 study of paclitaxel-eluting PTM-101 film in subjects with borderline resectable or locally advanced pancreatic cancers (AACR 2024) - "Approximately 3 weeks after PTM-101 placement, all participants began standard of care therapy which included mFOLFIRINOX. This study demonstrated that a PTM-101 implant was surgically feasible, safe, resulted in no systemic paclitaxel exposure, and caused a tumor size reduction in all 3 subjects. Additional studies may demonstrate the potential for PTM-101 to be a first-line adjunct prior to neoadjuvant therapy in treatment naïve, borderline resectable or locally advanced, pancreatic cancer."

Clinical • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Development of a novel implantable drug-eluting product for the local treatment of pancreatic adenocarcinoma (AACR 2024) - "PanTher created PTM-101, a novel absorbable drug formulation containing paclitaxel, designed to be locally applied via minimally invasive surgery to provide chemotherapy precisely to the peritumoral area in PDAC.Methods A study was conducted using 3 cadaveric abdomens to evaluate surgical feasibility of delivering PTM-101 via laparoscopy. This placement could hypothetically increase the amount of drug reaching the area behind the pancreas to target tumors which abut or encase the mesoportal vasculature. A decrease in the tumor-vessel interface could downsize pancreatic tumors, with the goal of increasing resection rates and post-resection local control."

Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

PanTher Therapeutics Presents Positive First-in-Human Data for PTM-101 in Pancreatic Cancer at AACR Annual Meeting (Businesswire) - "PanTher Therapeutics...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....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....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%)....PanTher presented a second poster at AACR describing the non-clinical development of PTM-101."

P1 data • Preclinical • Pancreatic Ductal Adenocarcinoma

A Phase I Study of PTM-101 as Neoadjuvant Therapy for Borderline Resectable or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (ANZCTR) - P1 | N=6 | Completed | Sponsor: PanTher Therapeutics | Recruiting ➔ Completed

Metastases • Trial completion • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Phase I study of PTM-101 as neoadjuvant therapy for borderline resectable or locally advanced pancreatic ductal adenocarcinoma: A trial in progress. (ASCO-GI 2023) - "PTM-101 is a paclitaxel-impregnated absorbable product which is designed for direct, sustained release of the therapeutic agent at the tumor site... This Phase I trial will assess the addition of PTM-101 prior to mFOLFIRINOX in 6 subjects with newly diagnosed borderline resectable or locally advanced PDAC...Enrollment is in progress and 3 patients have been enrolled and completed prospective follow up at the time of abstract submission. Clinical trial information: ACTRN12621000881831."

Clinical • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Phase I study of PTM-101 as neoadjuvant therapy for borderline resectable or locally advanced pancreatic ductal adenocarcinoma: A trial in progress. (ASCO-GI 2023) - "Clinical Trial Registry Number: ACTRN12621000881831"

Clinical • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

PanTher Therapeutics Awarded $14.2M from CPRIT to Advance Targeted, Localized and Sustained Cancer Treatment (Businesswire) - "PanTher Therapeutics...received a $14.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). The funding will be used to expand clinical development through Phase 2 of PanTher’s lead investigational therapy, PTM-101, a minimally invasive, implantable treatment for non-metastatic pancreatic cancer that provides direct, sustained release of a known therapeutic agent at the tumor site....'The funding will not only bring PTM-101 through the next phase of clinical development but will also allow us to accelerate the advancement of our novel Sagittari™ platform technology by expending internal resources to broaden our pipeline'."

Financing • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PanTher Therapeutics Doses First Two Patients in Phase 1 Trial of PTM-101 for Treatment of Pancreatic Cancer (Businesswire) - "PanTher Therapeutics (PanTher), a clinical-stage oncology company developing next-generation targeted therapies for solid tumors, announced today the dosing of the first two patients in its Phase 1 first-in-human clinical trial of PTM-101 for the treatment of pancreatic cancer."

Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PanTher Therapeutics Receives Ethics Approval to Initiate Phase 1 Clinical Trial of PTM-101 in Australia; Announces Appointment of Chief Medical Officer; Establishes Clinical Advisory Board (Businesswire) - “PanTher Therapeutics…announced today that it received approval from the Human Research Ethics Committee (HREC) to open a Phase 1 clinical trial of PTM-101 in Australia. PTM-101 is being developed for the treatment of pancreatic cancer.”

New P1 trial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer