Focal Medical, a privately held, biopharmaceutical company developing novel precision therapeutic products, today announced successful completion of the nonclinical development phase of Focal Medical’s Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003).
ACT-IOP-003 is a novel implanted precision therapeutic system intended to safely deliver multiple doses of gemcitabine (an FDA approved therapeutic agent) locally and actively into the pancreas using non-circulatory pathways. The completion of animal studies is a significant milestone in the development program in support of the efficacy, safety, and tolerability of ACT-IOP-003 for the treatment of pancreatic cancer. Focal Medical expects to initiate a pancreatic cancer clinical development program in 2024.
The pivotal GLP study was informed by unprecedented efficacy results in an orthotopic patient derived xenograft murine model of human pancreatic cancer, which was followed by a battery of pilot studies exploring safety and tolerability ranges in two separate healthy pancreas large animal models (canine and porcine). The final GLP study successfully demonstrated the safety and physiologic response to treatment of the final and clinical version of ACT-IOP-003 when employed under clinically relevant implant methods and treatment conditions in the pig.
“The completion of the development of our precision therapeutic system to deliver gemcitabine directly to the pancreas is an extraordinarily important milestone for Focal Medical,” commented Michael Aldridge, Focal Medical Chief Executive Officer.
“The system’s ability to precisely target the pancreas and actively deliver gemcitabine via non-circulatory pathways, with little systemic exposure is potentially enormously promising for patients diagnosed with locally advanced non-resectable pancreatic cancer. We look forward to initiating our clinical program in 2024.”