ACT-IOP-003 / Continuity Biosciences - LARVOL DELTA

A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Continuity Biosciences, LLC

First-in-human • New P1 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Continuity Biosciences Acquires Focal Medical to Advance Targeted Drug Delivery for Pancreatic Cancer (PRNewswire) - "Continuity Biosciences, LLC...announced today the acquisition of Focal Medical, Inc., a North Carolina-based biopharmaceutical company pioneering site-specific chemotherapy using iontophoresis. The acquisition represents a key step in Continuity's strategy to become a leader in device targeted therapeutics for intractable solid tumors....Focal Medical's lead product candidate, an iontophoresis device directed gemcitabine therapy for pancreatic cancer, has been cleared by the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) application. Phase 1b clinical trials are expected to begin later this year."

M&A • New P1 trial • Pancreatic Cancer

Focal Medical Receives FDA Clearance to Initiate Phase 1b Clinical Trial of ACT-IOP-003, a Targeted Therapeutic Product in Development for Pancreatic Cancer (Businesswire) - "Focal Medical, Inc...announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application to initiate a Phase 1b clinical trial of ACT-IOP-003, the Company’s first targeted therapeutic product. The trial will evaluate the safety and tolerability of targeted delivery of gemcitabine to locally advanced nonresectable (LANR) pancreatic tumors. The clinical trial is expected to start mid-2024....Up to 12 patients may be enrolled in the study which is expected to start mid-2024."

IND • New P1 trial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor