BANNOCKBURN, Ill., Dec. 14, 2011 /PRNewswire/ -- Pinnacle Biologics, Inc., a privately held specialty bio-pharmaceutical company announced today that it has obtained approval for an Orphan Drug Designation (ODD) for their product PHOTOFRIN® (porfimer sodium) as adjuvant therapy to surgery in the treatment of malignant pleural mesothelioma .
Malignant pleural mesothelioma is a form of cancer affecting the lining of the lungs. It is a rare, highly aggressive and devastating cancer with a poor prognosis. The incidence of malignant pleural mesothelioma has been linked to previous asbestos exposure and has grown from almost zero to approximately 3,000 new cases each year in the United States.(1)
"We are pleased to have obtained from the FDA the Orphan Drug Designation for PHOTOFRIN® for treatment in malignant mesothelioma," said Guillermo Herrera, Executive Chairman of Pinnacle Biologics. "Presently, the treatments for mesothelioma are palliative at best, and the outcome in patients with malignant pleural mesothelioma is very poor. Pinnacle is evaluating current clinical data so as to formulate a plan to bring this important treatment option to patients with malignant pleural mesothelioma in the near future."
According to Patrick Ross, M.D., Ph.D., Professor Clinical Thoracic Surgery, "I am pleased with the FDA decision granting PHOTOFRIN® orphan drug designation for mesothelioma. Photodynamic Therapy (PDT) with PHOTOFRIN® has shown tremendous value as a treatment modality in several forms of cancer providing doctors and health care providers with innovative options to treat unmet medical needs such as mesothelioma and other indications presently under investigation."
About Photodynamic therapy (PDT) and PHOTOFRIN®
Photodynamic therapy with