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

the FDA and the first approved treatment for all five subtypes of MDS.

The combination of azacitidine (Vidaza) and valproic acid is safe and active in advanced solid tumors - A.O. Soriano; Abstract #3547; June 2, 2007; 2-6pm; McCormick Place Convention Center, S102a

Results were reported this afternoon from a Phase I study of Azacitidine, a DNA hypomethylating agent, in combination with valproic acid, an HDAC inhibitor, in patients with advanced solid tumors. The study, which included patients with advanced forms of 10 different solid tumors, evaluated the safety and activity of the two compounds in combination.

Of 55 evaluable patients, 14 patients, or 25 percent, were observed to experience stable disease in a variety of advanced solid tumors. The duration of the patients' stable disease was four to 12 months, with a median of six months.

These data show that the combination of the two compounds was safe and active in patients with advanced solid tumors The data also indicated that the maximum tolerated dose of azacitidine when used in the combination was 75 mg/m2. Significant global DNA hypomethylation and histone acetylation were demonstrated.

Data Presented Saturday, June 2

Phase I/II study of a novel oral isotype-selective histone deacetylase (HDAC) inhibitor MGCD0103 in combination with Azacitidine in patients (pts) with high-risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous Leukemia (AML) - G. Garcia-Manero, MD, MD Anderson Cancer Center; Abstract #7062; June 2, 2007; 8:00-12:00 pm; McCormick Convention Center, S Hall A2

The combination of 5-azacytidine and valproic acid is safe and active in advanced solid tumors - A.O. Soriano, MD Anderson Cancer Center; Abstract #3547; June 2, 2007; 2:00-6:00pm; McCormick Place Convention Center, S102a

Tolerability and hematologic improvement assessed using three alternative dosing schedules of azacitidine (Vidaza) in patients with MDS - R. Lyons, US Oncology;
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