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FDA grants special status for mesothelioma drug in development

The U.S. Food and Drug Administration has granted Orphan Drug status to an experimental treatment for mesothelioma.


The drug, called CBP501, is in the later stages of a randomized Phase II clinical trial involving 63 patients with advanced pleural mesothelioma. The manufacturer, CanBas Co. of Japan, is testing CBP501 in combination with pemetrexed and cisplatin, the standard first-line chemotherapy for mesothelioma.


Orphan drugs are treatments for rare diseases that affect fewer than 200,000 people in the U.S. The FDA’s designation offers pharmaceutical companies that develop orphan drugs certain incentives, such as tax breaks, aimed at helping the drug gain regulatory approval.


Takumi Kawabe, CEO of CanBas, said the orphan drug status will help “advance CBP501 into phase III studies for this devastating malignancy.”


Mesothelioma is a rare cancer, caused by asbestos exposure, that kills 2,000-3,000 Americans each year. There is no cure and, because the disease spreads fast and is often diagnosed late, treatments — chemotherapy, radiation and surgery — are often ineffective and patients typically survive no more than a year or two.


CanBas describes CBP501 as a “novel synthetic peptide” that increases concentrations of cisplatin in cancer cells, enhancing its effectiveness. Early results suggest the drug slows the progression of mesothelioma by blocking cancer cells from transitioning through the cell cycle. The drug is also being tested for the treatment of non-small cell lung cancer, and Phase I trials have been completed in ovarian cancer patients.