Genta Initiates Phase III Trial of Genasense
Genta reported that it has enrolled the first patients in the Phase III trial of Genasense injection in advanced melanoma.
The double-blind, placebo-controlled AGENDA trial will randomize patients to receive either Genasense (oblimersen sodium) plus dacarbazine (DTIC), or DTIC alone, Genta said.
AGENDA will enroll approximately 300 patients and will be conducted at an estimated 100 sites worldwide, including North America, Europe and Australia. Accrual is expected to take approximately 18 months, with initial data expected shortly thereafter, the company added.
The company said its prior Phase III trial of this drug combination had shown that maximum benefit occurred in patients with normal baseline lactate dehydrogenase, a blood enzyme that strongly correlates with outcome. The AGENDA study is limited to patients whose baseline LDH is less than 0.8 times the upper limit of normal, the company added.