glufosfamide (D 19575) / Eleison Pharma - LARVOL DELTA

BullFrog AI and Eleison Pharmaceuticals Enter Agreement to Collaborate to Optimize Pivotal Phase 3 Trial (GlobeNewswire) - "Through this collaboration, BullFrog AI will apply its proprietary BullFrog Data Networks solution, powered by the bfLEAP platform, to analyze clinical data from Eleison’s ongoing Phase 3 trial and previous clinical studies of glufosfamide, an investigational treatment for pancreatic cancer. The platform will evaluate the current trajectory of the trial with respect to safety signals, extract predictive biomarkers for efficacy and safety performance from prior studies to support future trial design, and provide data-driven insights to optimize Eleison’s planned clinical trials for inhaled lipid-complexed cisplatin (ILC) and dibromodulcitol (DBD)."

Commercial • Pancreatic Cancer

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: Eleison Pharmaceuticals LLC. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: Eleison Pharmaceuticals LLC. | Trial completion date: Mar 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2022 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

An in vitro cytotoxicity of glufosfamide in HepG2 cells relative to its nonconjugated counterpart. (PubMed, J Egypt Natl Canc Inst) - "The current study reported for the first time cytotoxicity activity of glufosfamide in HepG2 cells in vitro. The obtained results confirmed the higher oncolytic activity of glufosfamide than its aglycone ifosfamide. The generated data warrants further elucidations by in vivo study."

IO biomarker • Journal • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • BCL2 • CASP3 • CASP9

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P3; N=480; Recruiting; Sponsor: Eleison Pharmaceuticals LLC.; Trial completion date: Jun 2021 ➔ Mar 2023; Trial primary completion date: Mar 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

BDI develops the only FDA clinical trial phase 3 pancreatic cancer treatment in the US [Google translation] (E-Today) - "BDI announced on the 28th that it will proceed with the acquisition of Ellison in the United States, although the financing schedule, which was scheduled for the end of this month, has been delayed for some time due to the management rights dispute that has occurred....Ellison is conducting a phase 3 clinical trial of Glufosfamid, the only approved pancreatic cancer second-line drug in the United States. In addition, FDA is developing treatments for rare diseases and cancer, including two pipelines in which phases 2 and 3 of FDA clinical trials are in progress respectively."

M&A • Trial status • Oncology • Pancreatic Cancer

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer (clinicaltrials.gov) - P3; N=480; Recruiting; Sponsor: Eleison Pharmaceuticals LLC.; Trial primary completion date: Dec 2016 ➔ May 2017

Trial primary completion date • Biosimilar • Gastrointestinal Cancer • Oncology • Pancreatic Cancer