Pinnacle Biologics (Bannockburn, IL), a biopharmaceutical R&D company specializing in rare diseases, has received FDA premarket supplemental approval for its Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber—a light delivery system used in photodynamic therapy (PDT) with the intravenous drug Photofrin (porfimer sodium). The combination has been approved for use in treatment of non-small cell lung cancer (NSCLC) and esophageal cancer.
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The system features a flexible, narrow cylindrical diffuser design that may provide greater access to tumors located in the right upper lobe of the lung and improve 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 company announced in January 2014 it has reached an agreement with the FDA under a special protocol assessment 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.
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