Pinnacle initiates pivotal Phase 3 trial in Germany for rare form of bile duct cancer

Oct 7 2014

University of Mannheim Medical Center is first site opened

Pinnacle Biologics, Inc. ("Pinnacle"), a subsidiary of Concordia Healthcare Corp., ("Concordia") (TSX: CXR) (OTCQX: CHEHF), announced today the initiation of the pivotal Phase 3 trial (OPUS) in Germany for a rare form of bile duct cancer for which there is currently no acceptable therapy. OPUS is an Open-label, multicenter phase 3 on the efficacy and safety of Photodynamic therapy (PDT) with PHOTOFRIN^® (porfimer sodium) for injection as treatment for Unresectable advanced perihilar cholangiocarcinoma (CCA) Bismuth type III/IV Study. The primary end point is Overall Survival (OS).

The global trial will enroll 200 patients from the U.S., Switzerland, Germany, South Korea and Canada. The first European site to begin screening patients for purposes of enrollment is the University Medical Center Mannheim, which belongs to the Heidelberg University, Germany. Four more European sites are scheduled to be initiated in the coming weeks. In August, Thomas Jefferson University Hospital in Philadelphia was the first U.S. site approved to enroll patients.

CCA or bile duct cancer is uncommon with only about 2,000–3,000 and 900 new cases of CCA diagnosed annually in the United States and Germany, respectively^i,ii; perihilar CCA (or Klatskin tumor) is a subset of that disease. Bile duct cancer is more prevalent in Asia and the Middle East, mostly because of a common parasitic infection of the bile ductⁱⁱⁱ.

"Bile duct cancer is rare and current treatment options are inadequate," said Dr. Sebastian Belle, senior endoscopist and oncologist. "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."

Pinnacle, a biopharmaceutical research and development company specializing in rare diseases, is a subsidiary of Concordia Healthcare Corp., a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population.

"Concordia has built a strong foundation around Pinnacle's development of PDT therapy with PHOTOFRIN," said Mark Thompson, CEO of Concordia. "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."

In January, Concordia announced an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) to enroll patients in this trial using PHOTOFRIN.