New Mesothelioma Drug Granted Special FDA Status

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The Federal Drug Administration (FDA) has granted orphan drug status to a medication that may help boost the effectiveness of the standard cisplatin/pemetrexed chemotherapy combination formesothelioma.

CBP501, produced by the Japanese Drug company CanBas, is a novel synthetic peptide that seems to enhance the effectiveness of cisplatin by acting on multiple pathways that govern the lifecycle of cells and the natural repair of DNA damage. By modulating the production of a certain enzyme, it allows mesothelioma cells to become more susceptible to the damaging effects of platinum (cisplatin) build-up. At the same time, it prevents the cells from properly repairing themselves. The drug has also shown the ability to resensitize mesothelioma cells that have become resistant to cisplatin.

The FDA’s ‘orphan drug’ designation is reserved for medications that address rare (fewer than 200,000 patients) and hard-to-treat illnesses like mesothelioma, for which treatment options are limited. As an orphan drug, CBP501 will be exempt from certain FDA fees and requirements, making it easier to bring it to market for mesothelioma patients sooner. Right now, treatments and research for mesothelioma and other rare diseases lags behind those affecting a larger percentage off the population, such as diabetes and heart disease.

Mesothelioma is a rare cancer of the mesothelium, the sac that encases the lungs and other organs. It is almost always caused by exposure to asbestos and often occurs 20 to 40 years after that exposure.  Because it is so aggressive, mesothelioma is usually treated using a multi-modal approach that includes chemotherapy. While the combination of cisplatin and pemetrexed is more effective than other drugs, most mesothelioma patients are still facing an uphill battle.  The median survival for mesothelioma is 16 months, according to the National Cancer Institute.

CBP501 is in the late stages of Phase II clinical trials for first-line treatment of malignant pleural mesothelioma for patients who are not eligible for curative surgery. Sixty-three mesothelioma patients have been enrolled in that trial which the company says should be completed in the first half of 2012.

Sources:

“CanBas’ CBP501 Receives FDA Orphan Drug Designation for Malignant Mesothelioma”, January 5, 2012, CanBas company press release. 
“Study of CBP501 + Pemetrexed + Cisplatin in Patients with Solid Tumors (Phase I) and Patients with Malignant Pleural Mesothelioma (Phase II)”, NIH Clinical Trials website, Accessed January 9, 2012.

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