US Company Earns FDA Orphan Drug Designation for Malignant Pleural 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 last week that they have 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, a rare cancer caused by exposure to asbestos, is one of the nearly 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.”
“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 in a press release. “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.”
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, is designated as an orphan drug. It was the first drug approved for mesothelioma treatment.
To find out more about PHOTOFRIN see Pinnacle Biologics’ website.