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Clinical Data Reported on Vidaza in Hematologic Malignancies and,Advanced Solid Tumors

stinal side effects were the most common adverse effects and dose modification was effective in many of these patients. HDAC inhibition of 20 percent or more was demonstrated in 78 percent of the eleven patients tested. Subsequent studies, expected to be disclosed later this year, are planned, including consideration of registrational opportunities as a single-agent and/or in combination with other agents in this patient population. Enrollment continues and treatment is ongoing in five patients. This trial is expected to complete enrollment by the end of this year.

"A Phase I/II Study of the Oral Isotype-Selective Histone Deacetylase (HDAC) Inhibitor MGCD0103 in Combination with Azacitidine in Patients with High-Risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous Leukemia (AML)" (Abstract #7062, Trial 005). The objectives of this study include determining response rates, maximum tolerated dose, safety, tolerability, pharmacokinetics and the degree of inhibition of the target enzyme.

A total of 37 patients were evaluated for activity and 30 of these patients received doses for which clinical activity had previously been documented (MGCD0103 doses of 60mg, 90mg and 110mg). Seventy-eight percent of patients, with their median age being 67 years, had prior chemotherapy. Eleven patients experienced objective clinical responses resulting in a 30 percent response rate for all patients, and a 37 percent response rate in the active dose ranges previously reported. Six of the 11 responders are continuing treatment, with their mean duration on study being about five cycles (approximately five months). Nine responses were seen in AML patients and two in MDS patients. Dose-limiting toxicities were gastrointestinal in nature. The maximum tolerated dose (MTD) was initially determined to be 110mg; however, upon patient treatment expansion at this dose, the MTD was re-evaluated and enrollment continued at starting doses of 90mg three times per week, with Vidaza do
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