Drug Company Files for Orphan Drug Designation for Mesothelioma Treatment

Pinnacle Biologics logo

Mesothelioma patients soon may have a new treatment option to consider for their rare and aggressive cancer.

Pinnacle Biologics, Inc., an Illinois-based bio-pharmaceutical company, announced this week it filed an Orphan Drug Designation (ODD) for its product PHOTOFRIN as an aid in the surgical treatment of malignant pleural mesothelioma.

Such a designation, often applied to drugs and treatments of diseases and conditions affecting 200,000 people or less, provides a special status for the drug. It will allow the manufacturer to receive tax credits and marketing incentives.

This program, put in place by The Orphan Drug Act, was designed to ensure that patients of rare diseases like mesothelioma were able to receive hopeful treatments despite the fact that the economic incentives of developing cures or treatments for large markets didn’t exist for rare diseases.

The cancer, primarily caused by asbestos exposure, affects between 2,000 and 3,000 Americans per year and has no known cure. Diseases of such limited populations fit ideally within the orphan drug classification.

A Sense of Hope

Pinnacle’s chairman, Guillermo Herrera, conveyed a positive stance on the company’s recent filing.

“We are pleased to file for the Orphan Drug Designation of PHOTOFRIN and potentially for its utilization in Mesothelioma,” Herrera said. “The treatments are palliative at best, and the outcome in patients with malignant pleural mesothelioma is poor. Pinnacle is committed to support the approval and expand the use of PHOTOFRIN® into new indications, where preliminary clinical results are very encouraging.”

Some medical experts have expressed optimism about the treatment as an option for patients.

“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,” said Joseph S. Friedberg, M.D., co-director of the Penn Mesothelioma and Pleural Disease Program at Penn Medicine, which is studying the 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. . . . [I]t has become a major focus of our research.”

Additional Treatment Options

PHOTOFRIN isn’t the only treatment hope for patients.

Beyond Pinnacle’s treatment, patients also have a variety of treatments that are designed to improve survival or increase quality of life, depending on the stage of diagnosis and development of the cancer. These treatments include chemotherapy, radiation, surgery and alternative forms of attacking the cancer.

As this disease is known to be aggressive, patients of asbestos cancer may also have the ability to consider using multiple treatment options to better assist their diagnosis.


Mark Hall joined the Mesothelioma Center as a writer in 2011. Prior to joining the content team, Mark graduated from the University of Florida and then spent several years writing about business, entrepreneurship and technology for various online publications.

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