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Clinical Trial Targeting Stage IV Mesothelioma Accepting Patients


Dr. Raffit Hassan has been focused on targeting the protein mesothelin for mesothelioma treatment for nearly 20 years. His work has led to the introduction of anti-cancer drugs being tested in various clinical trials. After seeing “exciting results” for mesothelioma patients in a 2012 clinical trial with Morab -009, he has moved on to another clinical trial for the nearly untreatable stage IV mesothelioma.

The Phase II international clinical trial, Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma, is designed to assess the efficacy and safety of anetumab ravtansine, also known as Bay 94-9343, versus vinorelbine, a chemotherapy agent used in the treatment of lung cancer, in patients with stage IV mesothelin-overexpressing malignant pleural mesothelioma.

“Anetumab ravtansine shows encouraging efficacy in patients with advanced mesothelioma which warrants further study,” said Dr. Hassan, a senior investigator and the head of the Thoracic and Solid Tumor Immunotherapy Section at the National Cancer Institute, at the World Conference on Lung Cancer in Sept. in reference to the phase I clinical trial of anetumab ravtansin, according to a Sept. 18 article from the Mesothelioma Applied Research Foundation.

The protein mesothelin is present in normal tissue, but certain types of malignant tumors, including mesothelioma, express high levels of mesothelin making it a primary target for tumor-specific drugs. In one study conducted by the University of Western Australia, researchers found elevated levels of soluble mesothelin-related protein or serum mesothelin in more than half of the mesothelioma patients at diagnosis.

Mesothelioma is a rare, incurable form of cancer, caused by exposure to airborne asbestos fibers, diagnosed in close to 3,000 Americans each year. Although mesothelioma can be treated with varying degrees of success with surgery, chemotherapy and radiation, there is still no known cure for the disease.

The Mesothelioma Applied Research Foundation had Dr. Hassan as a guest on its “Meet the Expert Series” in 2012 where he discussed the breakthroughs from his extensive research for finding new treatment options for mesothelioma patients. The experimental drug Morab 009 is designed to use mesothelin to seek out and bind to cancer cells, and then inject an immunotoxin into the tumor to kill it, according to Dr. Hassan.

Although Morab-009, now known as amatuximab, has not been approved for use in the U.S., the U.S. Food and Drug Administration granted orphan drug designation to the drug in 2012 for the treatment of malignant pleural mesothelioma.

“Mesothelioma is not a very common disease, but it’s a tumor for which we really need to develop a good treatment,” said Dr. Hassan during the 2012 teleconference.

The prognosis for mesothelioma patients is usually grim with an average survival time varying from 4 – 18 months after diagnosis. New treatment options are critical for improving survival and quality of life for mesothelioma sufferers.

The trial investigators hope to enroll 210 patients across all 95 sites, including the U.S., the UK, Australia, Turkey and Spain. The anticipated completion date is November 2017.

Find out more about the clinical trial at ClinicalTrials.gov.

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