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news.Genta has reported that the Data Safety Monitoring Board for Agenda, a Phase III trial of Genasense injection, has recommended that the trial be continued as originally planned after initial review of blinded safety data from the study.
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The study is designed to confirm certain safety and efficacy results from Genta’s prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients identified by a biomarker who have not previously received chemotherapy.
At the end of the first quarter, the trial had accrued approximately 50 patients with approximately 60% of planned investigative sites having been initiated. Countries with sites currently open for enrollment include the US, Canada, Australia, France, Germany, Austria, and the Czech Republic. The trial is planned to open at approximately 90 sites worldwide, and most remaining sites are expected to initiate within the next 30 days. Target accrual of 300 patients is expected to complete in the fourth quarter of 2008, with initial data expected shortly thereafter.
Loretta Itri, president, pharmaceutical development at Genta, said: “Investigator enthusiasm for Agenda is quite high, and we are currently recruiting at our expected rate. We believe the current rate, combined with enrollment from new sites that will open in the near future, should allow us to maintain our timelines for completion of accrual.”