US drugmaker Genta says that the first patients have been enrolled in the confirmatory Phase III trial of Genasense (oblimersen sodium) injection in advanced melanoma. The AGENDA study is a randomized, double-blind, placebo-controlled investigation in which patients are randomly assigned to receive Genasense plus dacarbazine or DTIC alone.
According to the firm, AGENDA will enrol approximately 300 patients and will be conducted at 100 sites worldwide, including North America, Europe and Australia. Recruitment of patients is expected to take approximately 18 months, with initial data expected shortly thereafter.
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