Dacogen (decitabine) for injection is being developed as a potential treatment for acute myeloid leukemia (AML) and chronic myelogenous leukemia (CML). Dacogen for injection is not approved for use in patients with AML or CML; safety and efficacy have not been determined in these populations.

How Dacogen Injection Works

Methylation is a process that acts like a switch to inactivate or “silence” genes through the addition of methyl (CH3) groups to certain regions of DNA. In many types of cancer, aberrant addition of methyl groups can result in genes that are “switched” off or on incorrectly. Dacogen for injection is believed to work by incorporating into DNA to reverse aberrant DNA methylation patterns, resulting in re-expression of tumor suppressor genes. By modifying the cause of disease, Dacogen for injection may give patients a new option for therapy and improved outcome.

In clinical trials, Dacogen for injection has been shown to have a broad spectrum of activity in several hematological malignancies as well as solid tumors. One phase 3 trial and two phase 2 trials of Dacogen for injection in patients with MDS have been completed. Additional trials in patients with MDS, as well as trials in patients with acute myelogenous leukemia (AML) are currently underway. A pivotal phase 3 study of Dacogen for injection in AML also initiated in 2005. A three-arm study designed to evaluate 3 different dosing regimens for Dacogen for injection in patients with MDS, including two shorter intravenous infusions and a subcutaneous administration, is currently underway.

Patients and health care providers seeking information regarding clinical trials may call MGI PHARMA toll-free at 1-800-562-5580 and press 1 to access our Medical Communications Help Line.