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Merck Mesothelioma Chemotherapy Drug Zolinza Enters Phase III Clinical Trials

October 14, 2008

Pharmaceutical giant Merck & Co., Inc. recently announced that its international trial of the chemotherapy drug Zolinza (vorinostat) in people with advanced malignant pleural mesothelioma has progressed to Phase III clinical trials. The company is currently accepting patients for enrollment in the study.

The decision to move to Phase III trials has come from a review of safety and efficacy data from Phase II Zolinza trials by the study’s independent Data Safety and Monitoring Board. Neither investigators nor Merck company researchers have access to the data obtained from the Zolinza study.

The study is a randomized, double-blind, placebo-controlled clinical trial designed to determine the safety, tolerability and anti-tumor activity of Zolinza with best supportive care as compared to best supportive care plus placebo in patients with advanced mesothelioma who have failed or are intolerant to prior chemotherapy, including pemetrexed in combination with either cisplatin or carboplatin. Mesothelioma patients not eligible for or not able to receive pemetrexed may also be considered for enrollment in the Zolinza clinical trial.

The Phase III Zolinza study is expected to enroll 660 patients. The locations of current participating centers include the United States, Belgium, Germany, the Netherlands, New Zealand, Spain, Sweden, Brazil, Australia, Italy, and the United Kingdom. For more information on eligibility requirements and how to participate in this study click here.

About Zolinza

Zolinza, which has the generic name vorinostat, is also known as suberoylanilide hydroxamic acid (SAHA). Zolinza was approved by the FDA in 2006 to treat a type of skin cancer, Cutaneous T-cell Lymphoma (CTCL), and Sézary's disease when other cancer treatments have failed or a patient is not showing progress with other medications.

Zolinza is an HDAC inhibitor, meaning it works by inhibiting the activity of enzymes called HDAC1, HDAC2, HDAC3 (Class 1) and HDAC 6 (Class II). Excess amounts of HDAC enzymes in some cancer cells prevent normal cellular activity. In past studies, Zolinza has decreased the amount of HDAC in cells, and this is believed to slow or stop the growth of cancer cells. The exact way in which Zolinza works, however, is not yet fully understood.

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