MGI Pharma, SuperGen data show Dacogen may help MDS, AML, CML patients

By Jennifer Chiou

New York, Dec. 12 - MGI Pharma, Inc. and SuperGen, Inc. presented data on Dacogen, including an alternative dosing study and phase 2 trial, that show the injection may assist patients with various diseases at the American Society of Hematology (ASH) 47th annual meeting.

The alternative dosing study applied to patients with myelodysplastic syndromes (MDS) and the phase 2 trial was for elderly acute myeloid leukemia patients.

"The data presented at ASH continue to support that Dacogen injection may represent a potential new therapeutic option for patients suffering from MDS and we look forward to an FDA [Food and Drug Administration] decision on Dacogen injection for this indication in early 2006," MGI president and chief executive officer Lonnie Moulder said in a news release.

"Additionally, Dacogen injection has shown clinical activity in a broad range of other hematologic malignancies, as both a monotherapy and in combination with other anti-cancer agents."

In the 96-patient alternative dosing study, the companies said the overall response rate was 47% and added their data supports the hypothesis that alternative Dacogen regimens are active in treating MDS patients and may offer dose-scheduling flexibility.

The companies tested best response, progression-free survival and toxicity in the 29-patient phase 2 trial for acute myeloid leukemia patients, finding 14% experienced a complete response, 17% had a partial response and 10% had stable disease. MGI Pharma and SuperGen said the interim results suggest Dacogen injection may be tolerated and may show activity in elderly patients with acute myeloid leukemia.

Additional phase 2 and 3 trials that test Dacogen's safety and efficacy showed MDS patient responses. Phase 2 data demonstrated Dacogen in combination with imatinib in patients with chronic myelogenous leukemia may be an active regimen for the patients, including those who have previously been treated with imatinib, the companies said.

The Dacogen injection New Drug Application is under review by the FDA for the treatment of MDS.

SuperGen is a Dublin, Calif., pharmaceutical company focused on therapies for solid tumors, hematological malignancies and blood disorders. It has Orathecin capsules for pancreatic cancer and Nipent for the hairy-cell leukemia.

Atlanta-based MGI Pharma is an oncology and acute care-focused biopharmaceutical company. It markets Aloxi injection and Gliadel Wafer in the United States.

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