CuraGen, TopoTarget begin patient dosing in phase 2 trial of PXD101 for treatment of mesothelioma

By Lisa Kerner

Charlotte, N.C., June 20 - CuraGen Corp. and TopoTarget A/S began patient dosing in a National Cancer Institute-sponsored phase 2 clinical trial of PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for treatment of mesothelioma, a type of cancer believed to be caused by exposure to asbestos.

About 37 patients with unresectable malignant pleural mesothelioma who have failed chemotherapy will be enrolled in the open-label study at multiple U.S. sites.

Each patient will receive PXD101 by intravenous infusion every three weeks, according to a company news release.

Response rate is the study's primary endpoint, with secondary endpoints of safety, time to treatment failure and survival.

The trial will also include pharmacodynamic studies and evaluation of certain genes and proteins.

"A significant amount of preclinical research suggests that HDAC inhibitors, including PXD101, alter the regulation of many genes, resulting in growth inhibition of human mesothelioma cells," study leader Suresh Ramalingam said in the release.

"There are no proven treatment options beyond the first-line chemotherapy regimen for mesothelioma, highlighting the importance of evaluating promising therapeutics like PXD101 for this patient population."

Up to 3,000 new cases of malignant mesothelioma are expected to be diagnosed in the United States this year. The five-year survival rate for mesothelioma is about 10%, with an average survival of one to two years following diagnosis, according to the release.

Located in Branford, Conn., CuraGen develops novel protein, antibody and small molecule therapeutics for the treatment of cancer, inflammatory diseases and diabetes.

TopoTarget is a Denmark-based biopharmaceutical company specializing in cancer therapies.

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