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July 06, 2015 9:25 PM ET


Company Overview of Pinnacle Biologics, Inc.

Company Overview

Pinnacle Biologics, Inc. develops and manufactures healthcare therapies for oncology and rare diseases. It revitalizes older brands and enables newer therapies to develop as orphan drugs to treat cancer indications. The company offers PHOTOFRIN (porfimer sodium), a photodynamic therapy drug that is indicated for the palliation of patients with obstructing esophageal cancer; the treatment of microinvasive endobronchial non-small-cell lung cancer; and the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. It also offers OPTIGUIDE fiber optic diffuser, a light delivery system consisting of a 400µm coated silica laser fiber, a proximal SMA-type las...

311 South Wacker Drive

Suite 4990

Chicago, IL 60606

United States

Founded in 2007





Key Executives for Pinnacle Biologics, Inc.

Co-Founder, Executive Chairman and Chief Executive Officer
Age: 61
Co-Founder, Vice Chairman and Chief Business Officer
Vice-President of PDT Business Unit-Us
Compensation as of Fiscal Year 2015.

Pinnacle Biologics, Inc. Key Developments

Pinnacle Biologics, Inc. Announces the Initiation of the Pivotal Phase 3 Trial in Germany

Pinnacle Biologics, Inc. announced 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(R) (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; 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 duct.

Pinnacle Biologics, Inc. Signs Collaboration Agreement with Orphan Canada for PHOTOFRIN

Concordia Healthcare Corp. announced that its subsidiary, Pinnacle Biologics, Inc. has signed a collaboration agreement for PHOTOFRIN(R) (porfimer sodium) with Orphan Canada. Under the agreement, Pinnacle and Orphan Canada will partner to support the continued supply of Photodynamic Therapy (PDT) using PHOTOFRIN in Canada. PHOTOFRIN is approved in Canada for the treatment of certain forms of gastrointestinal, lung and bladder cancers. In January, Concordia received FDA approval to enroll patients with perihilar CCA in a pivotal Phase 3, multicenter clinical trial using PHOTOFRIN. This international trial will enroll patients from the U.S., Switzerland, Germany, South Korea and Canada. The trial will study the efficacy and safety of PDT with PHOTOFRIN for injection as treatment for unresectable advanced perihilar CCA Bismuth type III/IV. Two sites, CHUM-Hopital St-Lux, Quebec and St. Michael's Hospital, Ontario, have currently been selected to participate with more sites expected to be operational within the next months.

FDA Approves Optiguide DCYL700 Fiber Optic Diffuser Series Flexible Fiber of Pinnacle Biologics, Inc

Concordia Healthcare Corp. announced that its subsidiary Pinnacle Biologics, Inc. 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.

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