SuperGen, Inc announced that encouraging preliminary data from a multi-center clinical study of the investigational anticancer compound Dacogen (decitabine) for injection suggests that the drug is active against Gleevec (imatinib mesylate), refractory chronic myelogenous leukemia (CML). Results involving the subset of patients in the study who enrolled at the University of Texas MD Anderson Cancer Center, under the supervision of principal investigator Dr. Hagop Kantarjian, were presented at the "Chemotherapy Foundation Symposium XXI - Innovative Cancer Therapy for Tomorrow" in New York city.
The Chemotherapy Foundation, The Page and William Black Post-Graduate School for Continuing Medical Education and the Mount Sinai School of Medicine jointly sponsored the event.
In the study of low-dose Dacogen, a total of 27 patients, in various phases of CML and all of who had failed treatment with imatinib mesylate, were enrolled and received either 15 mg/m2 or 10 mg/m2 intravenously for 10 days, depending on the stage of the disease. A hematologic response was achieved in 63 per cent (17/27) and a cytogenetic response was achieved in 40 per cent (11/27, with patients in the chronic phase achieving both hematologic and cytogenetic responses). No grade 3 or 4 non-hematological side effects were reported. Hematological toxicity was manageable with more than 50 per cent of patients experiencing thrombocytopenia or neutropenia with fever, both of which are reversible.
An additional clinical study, also conducted by Dr. Kantarjian, enrolled 10 patients who presented with untreated accelerated or blastic phase CML. Each patient was treated with a combination of Dacogen (15 mg/m2 intravenously for 10 days) and imatinib mesylate (600 mg orally daily). Of the ten patients enrolled, six are currently evaluable, with two patients having achieved a complete hematologic response and one patient having achieved a minor cytogenetic response to date. No toxicity data has been reported at this time.
"We are very encouraged by this preliminary data and believe that Dacogen, both as a single agent and in combination therapy, could become a valuable tool in the treatment of a number of hematological malignancies, including myelodysplastic syndrome, chronic myelogenous leukemia and acute myelogenous leukemia," said Hagop Kantarjian, MD, chairman and professor, Leukemia Department at the University of Texas MD Anderson Cancer Center.
The primary mechanism of action for Dacogen in cancer is thought to be modification of aberrant DNA methylation, a major mechanism for regulating gene expression and reversing resistance to chemotherapy treatment.