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S. oncology cooperative group, and was sponsored by the National Cancer Institute. In this trial, all patients received standard chemotherapy with daunorubicin and cytarabine ( | | | ), and they were randomly assigned to receive Genasense or no additional therapy.

Genasense was given during initial therapy and in two additional chemotherapy cycles after achieving complete remission ( | | | ). This trial enrolled patients over the age of 59 who had not previously received chemotherapy. Due to the accumulation of additional genetic mutations, these patients are known to have an inferior outcome with standard chemotherapy, achieving lower rates of CR that result in shorter survival.

The primary endpoint in the trial is a comparison of overall survival; secondary endpoints include percent CR, remission duration, safety, and other assessments. The CALGB has also conducted a number of correlative laboratory tests in this trial, including measurements of Bcl-2, the biochemical target of Genasense. A minimum target of 500 patients was prospectively specified for accrual, a goal that has now been reached.

Data from this trial are expected in 2007. Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment.

Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.