SuperGen Comments on Preliminary Efficacy Update on EORTC Phase 3 Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic...(sign This Phase 3 open-label randomiz...),Health

This Phase 3 open-label, randomized, multicenter, controlled trial evaluated overall survival of patients receiving Dacogen plus BSC versus BSC only. The study involved 233 elderly patients, greater than or equal to 60 years of age, with predominantly high-risk or Intermediate-2 type MDS.

Patients included in the trial had primary or secondary MDS, with or without previous therapy with growth factors, immunosuppressive agents or hydroxyurea. In order to participate in the study, patients had to have bone marrow blast counts between 11 and 30 percent. Patients with blast counts below 10 percent were required to have had poor prognosis cytogenetics in order to be eligible for randomization.

About MDS

Myelodysplastic syndromes, or MDS, is a bone marrow disorder characterized by the production of poorly functioning and immature blood cells. People with MDS may experience a variety of symptoms and complications, including anemia, bleeding, infection, fatigue and weakness. Those patients with high-risk MDS may experience bone marrow failure, which may lead to death from bleeding and infection. Over time, MDS can progress to acute myelogenous leukemia (AML). The Aplastic Anemia and MDS International Foundation currently estimates that up to 30,000 new cases of MDS are diagnosed annually in the Unites States.

About Dacogen(R)

Dacogen(R) (decitabine) for Injection was developed through a pivotal Phase 3 study by SuperGen and partnered to MGI PHARMA, INC. (acquired by Eisai Co., Ltd.). MGI PHARMA subsequently sublicensed all Dacogen rights outside of North America to Janssen-Cilag, a Johnson & Johnson Company. Dacogen was approved by the U.S. Food and Drug Administration on May 2, 2006 and is indicated for the treatment of patients with MDS, including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with rings sideroblasts, refractory a
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