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Pharmion and Methylgene Report Favorable Results for Phase 2 MGCD0103 Single- Agent Studies in Relapsed or Refractory Lymphomas at the 49th American Society of Hematology (ASH) Meeting
Date:12/9/2007

have been enrolled in this ongoing open-label Phase 2 study of refractory/relapsed classical Hodgkin lymphoma (HL). The majority of these patients have disease that has progressed following stem cell transplant as well as other subsequent therapies (100% of patients have undergone prior chemotherapy, 88% prior bone marrow or stem-cell transplant and 76% radiation treatment).

Of 21 evaluable patients who received the 110 mg starting dose, eight (38 percent) showed objective responses - two complete responses (CR) and six partial responses (PR). The overall disease control rate (CR+PR+stable disease (SD) greater than or equal to 6 cycles) was 43 percent. The median time to response was two cycles (one cycle equals 28 days). Tumor reductions were observed in 86 percent of patients who had CT scans and 57 percent of the patients experienced tumor shrinkages greater than 30 percent. The two CR patients have a preliminary progression-free survival (PFS) of 14 and 9 months at the time of analysis. The range of PFS from the responder group is 56 to greater than 396 days.

Adverse events (AE) associated with MGCD0103 administration of grade 3 or higher included pneumonia (15 percent), and thrombocytopenia (12 percent) and fatigue (9 percent).

Preliminary and early data from the 85 mg cohort revealed all five evaluable patients with tumor reduction of greater than or equal to 30 percent, including one PR and 2 near-PRs (49 percent and 45 percent tumor reduction). Three of these patients are ongoing in the 85 mg cohort. Enrollment in this cohort continues in order to gain additional experience at the 85 mg doses subsequent to planning potential future trials in this and other indications.

In summary, results from this ongoing trial suggest that single-agent MGCD0103 demonstrates significant anti-tumor activity in relapsed/refractory classical HL and is well-tolerated, with dose modifications used as necessary to manage toxicities. An 85 mg dose is c
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SOURCE Pharmion Corporation
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