Merck mesothelioma chemotherapy drug enters phase iii trials

Pharmaceutical company Merck & Co., Inc. this week released an announcement about its international trial of chemotherapy agent Vorinostat (Zolinza®) in people with advanced malignant pleural mesothelioma. The company says it has recently progressed to Phase III clinical trials, and is currently accepting patients for enrollment. Vorinostat (Zolinza®) is an anticancer drug called an HDAC inhibitor. It works by inhibiting activity of enzymes called HDAC1, HDAC2, HDAC3 (Class 1) and HDAC 6 (Class II). In some cancer cells, excess amounts of the HDAC enzymes prevent normal cellular activity. In past in vitro studies, Zolinza® has decreased the amount of HDAC in cells, and this is believed to slow or stop the growth of cancer cells. However, the exact way in which Zolinza® works is not yet fully understood. Currently the data obtained from the study remains blind to both investigators and Merck company researchers. The decision to move to Phase III trials has come from a review by the study’s independent Data Safety and Monitoring Board of safety and efficacy data from Phase II trials. The Vorinostat study is a randomized double-blind placebo-controlled trial, and is designed to determine the efficacy and safety of the drug when taken orally. Vorinostat is being compared to “best supportive care” plus a placebo drug. Patients admitted into the study have advanced pleural mesothelioma and have either failed or are intolerant to chemotherapy in the past. Phase III clinical trials will enroll up to 660 participants, from a variety of locations including the United States, Belgium, Germany, the Netherlands, New Zealand, Spain, Sweden and the United Kingdom. Eric Rubin, M.D., vice president, oncology clinical research, Merck Research Laboratories, says, “With no currently approved regimens for relapsed or refractory mesothelioma, continued research focused on identifying targeted therapies and differentiated approaches is critical. We are pleased that the investigation of vorinostat for the treatment of advanced mesothelioma has advanced into Phase III development and look forward to the results of this now expanded trial.” The Phase III trial will examine safety and toxicity issues as well as the effects of the drug on mean survival time of patients with advanced pleural mesothelioma. Other factors which will be examined include the duration of any positive response to the drug and progression-free survival time. People interested in participating in the trial can call toll-free 1-866-890-6619 (in the U.S.) and 1-888-577-8839 (outside of the U.S.) or visit www.merckcancertrials.com for further information. (Source: Asbestos and Mesothelioma News)