SuperGen Inc., a pharmaceutical company dedicated to the discovery, rapid development and commercialization of therapies for solid tumours and haematological malignancies, commented on the preliminary efficacy data from a trial, initiated in 2002, comparing Dacogen (decitabine) for injection to best supportive care (BSC) in elderly patients with myelodysplastic syndromes (MDS).

The data did not demonstrate a statistically significant advantage of Dacogen treatment on median survival compared to BSC, the primary endpoint of the study. However, response rates were similar to those observed in other clinical trials of Dacogen in patients with MDS. The trial, conducted by the European Organisation for Research and Treatment of Cancer (EORTC), administered Dacogen on a three-day dosing schedule in which the number of treatment cycles was limited. MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells.

Subsequent to database lock and the completion of data analysis, comprehensive results of the study, including secondary efficacy endpoints and safety data, will be presented by EORTC at an upcoming scientific forum.

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.

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 anaemia, 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 leukaemia (AML). The Aplastic Anaemia and MDS International Foundation currently estimates that up to 30,000 new cases of MDS are diagnosed annually in the Unites States.

Dacogen (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 US 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 anaemia, refractory anaemia with rings sideroblasts, refractory anaemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukaemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups.

Eisai Inc. is conducting a series of clinical trials in the service of Dacogen's development to further understand the optimal treatment for MDS and related conditions. Currently, more than 30 clinical studies of Dacogen are being conducted, including a phase 3 pivotal trial to evaluate Dacogen in patients with AML.