Phase 3 trial now recruiting for treatment of rare bile duct cancer

A university in Germany has begun recruiting patients for a phase 3 clinical trial to study the safety and efficacy of photodynamic therapy with porfimer sodium to treat a rare form of bile duct cancer, according to a press release.

Porfimer sodium (Photofrin, Pinnacle Biologics) is a photosensitizing injectable agent used to treat various cancers, including esophageal, non–small cell lung cancer and high-grade dysplasia in Barrett’s esophagus. The OPUS trial will include 200 patients from across the United States, Switzerland, Germany, South Korea and Canada and will test the combination of photodynamic therapy with porfimer sodium to treat unresectable advanced perihilar cholangiocarcinoma Bismuth type III/IV.

Pinnacle, a subsidiary of Concordia Healthcare, established an agreement with the FDA in January under a special protocol assessment to enroll patients in the global trial.

“Concordia has built a strong foundation around Pinnacle's development of PDT therapy with photofrin,” Mark Thompson, CEO of Concordia, said in the release. “Our experienced clinical team combined with calculated investment has enabled us to advance development of this treatment, which, because of its application, has the potential for use among a range of rare and difficult to treat cancers like mesothelioma and bile duct cancer.”

Germany is the first European site to begin screening patients for enrollment at the University Medical Center Mannheim, Heidelberg University. Four more European sites are scheduled to be initiated in the coming weeks, according to the release. In August, Thomas Jefferson University Hospital in Philadelphia was the first US site approved to enroll patients.

Porfimer sodium was granted orphan drug designation (ODD) by the FDA in 2004 to treat cholangiocarcinoma, and in December 2011, the FDA granted a second ODD to the drug as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma, according to the release.