MDS Patients on Five-Day Vidaza(R) Dosing Schedules Achieve Transfusion Independence Consistent with Seven-day Schedule

MDS Patients on Five-Day Vidaza(R) Dosing Schedules Achieve Transfusion Independence Consistent with Seven-day Schedule

Pharmion Corporation (NASDAQ:PHRM) today announced interim data from a Phase 2 clinical trial evaluating three alternative five-day dosing schedules for Vidaza(R) (azacitidine for injection) that demonstrated safety and response profiles which are consistent with those achieved with the FDA-approved seven-day regimen, as reflected in rates of hematologic improvement (HI) and red blood cell (RBC) transfusion independence. These responses were observed in a broad range of MDS patients, including FAB low-risk patients. These data were presented at the 49th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Atlanta.

"The data from this study suggest that a five-day schedule is as effective as the currently approved seven-day schedule at achieving RBC transfusion independence and hematologic improvement in MDS patients," said Dr. Andrew R. Allen, executive vice president and chief medical officer of Pharmion. "A dosing schedule that circumvents the need for weekend dosing would provide a meaningful benefit in terms of convenience to these patients and clinicians."

Roger M. Lyons, MD, FACP, principal investigator of the study at Cancer Care Centers of South Texas and U.S. Oncology Research San Antonio delivered an oral presentation titled "Results of the Initial Treatment Phase of a Study of Three Alternative Dosing Schedules of Azacitidine (Vidaza) in Patients with Myelodysplastic Syndromes (MDS)" (Abstract #819).

In this Phase 2 prospective, multi-center, randomized, open-label 3-arm trial, a total of 151 MDS patients were randomized to one of three regimens administered subcutaneous every four weeks for six cycles: Vidaza 5-2-2 (75 mg/m2/day x 5 days, two days off therapy, two additional days at same dose as the first five days; N=50); Vidaza 5-2-5 (50 mg/m2/day x 5 days, followed by 2 days off therapy and five additional days at the same dose as the first five days; N=51); Vidaza 5 (75 mg/m2/day x 5 days; N=50). The majority of patients (57 percent) were classified with FAB low-risk disease (RA/RARS), while 33 percent had FAB higher-risk MDS (RAEB/RAEB-T).

"These trial data suggest that transfusion dependency is reduced with five-day dosing schedules," said Dr. Lyons. "This could succeed in normalizing cytopenias and improve the daily lives of these patients."

The study, which is ongoing, includes this preliminary analysis of the first six cycles of therapy. Across the three alternative dose regimens, between 44 and 55 percent of evaluable patients experienced HI, defined as major or minor in at least one cell line (erythroid, platelet, or neutrophil). This reflects HI of 44, 52, and 55 percent in the Vidaza 5-2-2, Vidaza 5-2-5, and Vidaza 5 arms, respectively.

Further, across the three alternative dose regimens, between 55 and 63 percent of patients who were red blood cell (RBC) transfusion dependent at baseline achieved transfusion independence. This reflects overall RBC transfusion independence rates of 55, 60, and 63 percent in the Vidaza 5-2-2, Vidaza 5-2-5, and Vidaza 5 arms, respectively. Among transfusion-dependent patients with FAB low-risk disease, RBC transfusion independence was achieved by 60, 56, and 61 percent, respectively.

Each dosing schedule offered a safety profile similar to the well- established profile seen with standard Vidaza dosing. No treatment-related mortalities were reported. Most treatment-related grade 3 and 4 adverse events were hematological.