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Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
Date:1/14/2008

sion- dependent patients on Vidaza achieved transfusion independence compared to 11 percent of transfusion-dependent patients on CCR, and for patients on Vidaza, the median time to transformation to AML during the treatment period was 26 months, compared to 12 months for patients on CCR therapy.

Treatment with Vidaza was well tolerated, demonstrating a safety profile consistent with previous experience.

Vidaza is the first of a new class of anti-cancer compounds known as demethylating agents, a subset of a category of drugs referred to as epigenetic therapies. Epigenetics refers to changes in the regulation of gene expression. DNA methylation and histone deacetylation are two of the more widely studied epigenetic mechanisms.

About Vidaza

In May 2004, the FDA approved Vidaza, the first in a new class of drugs called demethylation agents, for treatment of all five subtypes of Myelodysplastic Syndromes (MDS). These subtypes include: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) if accompanied by neutropenia or thrombocytopenia or requiring transfusions; refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

Vidaza is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of Vidaza required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of Vidaza cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non- proliferating cells are relatively insensitive to Vidaza. Vidaza was approved in the U.S. for IV administration in January 2007.
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SOURCE Pharmion Corporation
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