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news.Concordia Healthcare subsidiary Pinnacle Biologics has started an open-label, multicenter Phase III trial (OPUS) designed to evaluate the efficacy and safety of Photodynamic therapy (PDT) with PHOTOFRIN (porfimer sodium) for injection to treat cholangiocarcinoma (CCA).
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The trial is being conducted in Germany for a rare form of bile duct cancer for which currently there is no acceptable therapy.
About 200 patients will be enrolled in the trial from the US, Switzerland, Germany, South Korea and Canada.
The University Medical Center Mannheim is the first European site to start screening patients for purposes of enrolment, and four more European sites are scheduled to be started in the coming weeks.
Senior endoscopist and oncologist Dr Sebastian Belle said: "Photodynamic therapy with Photofrin has demonstrated promise as an effective treatment that can prolong life for these very ill patients.
"We hope the trial will provide important new information to guide development of this targeted cancer therapy for patients with uncommon and difficult-to-treat cancers."
PHOTOFRIN is used to treat esophageal cancer, non-small-cell lung cancer and high-grade dysplasia in Barrett’s esophagus.