US Company Files for Orphan Drug Designation for Mesothelioma Treatment
Pinnacle Biologics, an Illinois company that specializes in revitalizing healthcare therapies to fulfill their true potential and to maximize favorable patient outcomes, announced this week that they have filed an Orphan Drug Designation (ODD) with the U.S. Food and Drug Administration for their product Photofrin (porfimer sodium) as adjuvant therapy to surgery in the treatment of malignant pleural mesothelioma.
Malignant pleural mesothelioma, a rare cancer caused by exposure to asbestos, is one of the close to 7,000 diseases designated as rare, or “orphan,” in the United States. An orphan disease status is assigned to a disease or disorder if it affects fewer than 200,000 Americans at any given time. Mesothelioma is incurable, but is often treated with a combination of surgery, chemotherapy and radiation.
Photofrin, given intravenously, is used in conjunction with photodynamic therapy (PDT). PDT is a light-based cancer treatment using non-burning laser lights to treat mesothelioma. According to Pinnacle, when injected, “Photofrin is attracted to and linger in certain tissues, especially cancer cells, and tumor destruction is by biochemical reactions, not by heat.”
Guillermo Herrera, Executive Chairman of Pinnacle Biologics, said, “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.”
Through the FDA, a pharmaceutical company developing a drug to treat an orphan disease can be granted with an orphan designation. Alimta (pemetrexed), a chemotherapy drug used in combination with cisplatin for treating pleural mesothelioma, distributed by Eli Lilly and Company, received a priority review from the FDA in 2004 and is designated as an orphan drug. It is the first, and only, drug approved for mesothelioma treatment.
To find out more about PHOTOFRIN see Pinnacle Biologics’ website.
