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ZOLINZA (vorinostat) in combination with bortezomib demonstrated clinical activity
Date:12/8/2007

ATLANTA, GA, December 8, 2007 -- Results from two investigational Phase I trials of ZOLINZA (vorinostat) in combination with bortezomib provide preliminary anti-tumor activity in patients with relapsed and/or refractory multiple myeloma. Data from one study showed that 10 of 21 (48 percent) evaluable patients had a partial or minimal response from the ZOLINZA and bortezomib combination treatment. Data from a second study, sponsored by the United States National Cancer Institute under a Clinical Trials Agreement with Merck & Co., Inc., demonstrated 10 of 23 (43 percent) evaluable patients had a partial response or greater from the combination treatment. These data were presented today at the 49th Annual Meeting of the American Society of Hematology (Abstracts #1168 and #1172).

These trials are the first to evaluate the safety and efficacy of ZOLINZA as part of a combination regimen in patients with relapsed and/or refractory multiple myeloma. The primary objective of both trials was to determine the maximum tolerated dose (MTD) of ZOLINZA in combination with bortezomib in these patients. Bortezomib is regarded as a standard treatment option against multiple myeloma; the use of ZOLINZA in this patient population is investigational.

With more than 50,000 men and women living with multiple myeloma, continued research is imperative, as patients eventually relapse after completing therapy, said Jose Garcia-Vargas, M.D., senior director, Clinical Oncology, Merck Research Laboratories. These data provide a preliminary evaluation of the combination of vorinostat with bortezomib in patients with advanced multiple myeloma, including those who've previously received bortezomib therapy. Larger clinical studies are needed to confirm these results.

Study results

In the multicenter open-label, escalating-dose Phase I trial, a total of 24 patients with relapsed or refractory multiple myeloma were administered oral ZOLINZA 200 mg bid
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Contact: Gina Juliano
gina_juliano@cohnwolfe.com
917-359-5521
Cohn & Wolfe
Source:Eurekalert

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