Genetronics Initiates Pancreatic Cancer Trial Using MedPulser

Genetronics Biomedical, a late-stage developer of oncology and other therapies using electroporation to deliver drugs and nucleic acids, has initiated a Phase I clinical trial to treat pancreatic cancer using its MedPulser Tumor Ablation System.

The primary endpoint of this FDA-approved study is to determine the safety profile of the MedPulser electroporation therapy in conjunction with intralesionally injected bleomycin for the treatment of unresectable or incurable locally advanced pancreatic cancer. Genetronics aims to complete enrollment of up to 12 patients by the end of 2005.

The Office of Orphan Product Developments has granted Genetronics orphan designation for the treatment of pancreatic cancer. Upon successfully securing marketing approval from the FDA for this indication, Genetronics could then also secure orphan-drug status, providing U.S. marketing exclusivity for seven years and certain tax benefits, the company said.