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Pinnacle Biologics Files for Orphan Drug Designation for PHOTOFRIN® in the Treatment of Patients with Malignant Mesothelioma.
Date:10/24/2011

BANNOCKBURN, Ill., Oct. 24, 2011 /PRNewswire/ -- Pinnacle Biologics, Inc., a privately held specialty bio-pharmaceutical company announced today that it has filed 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 file for the Orphan Drug Designation of PHOTOFRIN® and potentially for its utilization in 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 committed to support the approval and expand the use of PHOTOFRIN® into new indications such as Malignant Pleural Mesothelioma, where preliminary clinical results are very encouraging."

According to Joseph S. Friedberg, MD, Chief, Section of Thoracic Surgery - Penn Presbyterian Medical Center; Co- Director, Penn Mesothelioma and Pleural Disease Program at Penn Medicine, "In studies completed at Penn, photodynamic therapy (PDT), in conjunction with surgery, has shown some very promising results for the treatment of mesothelioma, a highly lethal cancer of the chest cavity lining.  By utilizing PDT as an intraoperative treatment, we have been able to develop a technique where we can reliably preserve the patient's lung. When compared to other treatments, this combination of lung-sparing surgery, PDT and standard chemotherapy appears to have a positive impact on both survival and quality of life. Based
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SOURCE Pinnacle Biologics, Inc.
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