FDA grants PMA for Pinnacle's Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber

Mar 26 2014

Supplemental approval will expand PDT with Photofrin® treatments in specific lung and esophageal cancers

Concordia Healthcare Corp. (Concordia or the Company) (TSX:CXR) (OTCQX: CHEHF) announced today that its subsidiary Pinnacle Biologics, Inc. (Pinnacle), a biopharmaceutical research and development company specializing in rare diseases, was granted U.S. Food and Drug Administration (FDA) premarket supplemental approval (PMA) for its Optiguide® DCYL700 Fiber Optic Diffuser Series flexible fiber.

The Optiguide DCYL700 Fiber Optic Diffuser Series is a light delivery system used in Photodynamic Therapy (PDT) with PHOTOFRIN® (porfimer sodium) approved for use in the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The system features a more flexible, narrower cylindrical diffuser design that may assist physicians by providing greater access to tumors located in the right upper lobe of the lung and by improving maneuverability in other potentially challenging anatomic areas of the bronchus.

According to thoracic surgeon Patrick Ross MD, Ph.D., chairman of the Pinnacle Scientific Advisory Board, "One of the key benefits of this new diffuser fiber is that it will offer improved compatibility with current endoscopic equipment. This may allow doctors to use bronchoscopes with smaller therapeutic channels and may allow easier access to NSCLC tumors located in the right upper lobe of the lung as well as other potentially challenging anatomic areas of the airways in the lungs."

The Optiguide®DCYL700 Fiber Optic Diffuser Series is the latest addition to Pinnacle's portfolio of photodynamic products. Pinnacle's complete PDT technology platform and the science behind it has enabled the company to accelerate research into new indications. The company announced in early January it has reached an agreement with the FDA under a special protocol assessment ("SPA") to enroll patients with an advanced form of bile duct cancer in a pivotal Phase 3 clinical trial, a cancer type for which there is currently no approved therapy.

"Pinnacle has continued to aggressively advance photodynamic technology, design and materials in furtherance of its mission to expand and improve treatment options for critically ill patients with rare diseases like lung and esophageal cancers, " said Mark Thompson, CEO of Concordia. "We are pleased that this newly approved Optiguide®DCYL700 Fiber Optic Diffuser Series device will give physicians a new and important tool in their PDT armamentarium."