The members of the DSMB
approved unanimously the continuation of the trial having concluded that one month post treatment, C-Cure and C-Cathez shows no safety issue that compromises the continuation of the CHART-1 Phase III study.
It is crucial that all members of the research team understand the role and responsibilities of the DSMB
when conducting clinical research.
Food and Drug Administration (FDA), required that an initial group of patients be treated with 1500 mg of voxelotor to allow assessment by the DSMB
prior to enrolling adolescent patients age 12 to 17 into this ongoing Phase 3 study.
According to the company, the protocol and the DSMB
charter approved by regulators did not include interim analysis or futility analysis for survival.
Enrollment in the second cohort is expected to be completed in 2016 and, if the data are positive, it is anticipated that DSMB
approval to proceed to the third cohort will be received by the end of 2016.
reviewed safety data from the subjects enrolled in our two pivotal Phase III clinical trials and recommended that GTx continue with the trials as planned," said Mitchell S.
We are very pleased that the DSMB
recommended we continue enrolling our Phase 3 trial after their review of available safety and efficacy data," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics.
As in the Phase 1b portion of the study, initiation of each higher dose cohort will follow review of the data from the previous cohort and there will be a DSMB
review between the 25 mg and 50 mg CMX157 cohorts, concluded the company.
recommended that the study should continue as planned and identified no safety concerns.
7] Due to the dispute with the company, the study leadership was unable to obtain the final data, and published from the data submitted to the DSMB
, with updates during the summer of 1999.
Additionally, the DSMB
has authorized the Company to treat all three patients in the second cohort of its European trial for SMD.
Following review of the safety data, the DSMB
authorized that the clinical trial proceed with enrollment and dose escalation for the second cohort.