TORONTO AND CHICAGO - Concordia Healthcare Corp. ("Concordia") (TSX: CXR) (OTCQX: CHEHF), a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population, and its subsidiary Pinnacle Biologics, Inc., a biopharmaceutical research and development company specializing in rare diseases, today announced the initiation of a randomized Phase 3 clinical trial to treat a rare form of bile duct cancer for which there currently is no acceptable therapy.
The trial will study 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.
"The fast pace at which we have advanced this trial, from FDA approval to investigator training to site initiation, is an indication to us of the medical community's support and need for new treatments like PDT therapy with PHOTOFRIN®," said Mark Thompson, Chief Executive Officer of Concordia Healthcare Corp.
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 pivotal Phase 3, multicenter clinical trial using PHOTOFRIN®. The global trial will enroll 200 patients from the U.S., Switzerland, Germany, South Korea andCanada. Thomas Jefferson University Hospital in Philadelphia is the first site approved to enroll patients.Concordia expects more sites to be operational over the next few weeks.
Dr. David E. Loren, Associate Director of Endoscopy and Co-Director of the Pancreaticobiliary Section, will lead the trial at Thomas Jefferson University Hospital.
"The approved treatment options for patients with bile duct cancer, known as cholangiocarcinoma, are inadequate and only prolong life by a few months. Previous studies have shown promise for photodynamic therapy with PHOTOFRIN® in prolonging life more than a year for those affected by this terrible cancer. We are hopeful that this trial will provide the results needed to approve the use of this treatment for use in cholangiocarcinoma," said Dr. Loren.
PHOTOFRIN® has received an FDA orphan drug designation (ODD) to treat CCA, a rare disease; perihilar CCA represents a very small subset of CCA, with only about 2,000-3,000 new cases diagnosed annually in the United States.