Carlayne Jackson, Professor of Neurology at the University of Texas Health Science Center San Antonio and Chair of the DSMB
, stated "based on the laboratory data and reported adverse events to date, we are recommending continuation of the existing protocol and have no concerns about the safety or tolerability of both the intrathecal and intramuscular injections.
David Dodd, Chairman and CEO of Aeterna Zentaris, commented, This positive second recommendation from the DSMB
is an important milestone since it supports our continuation of the ZoptEC Phase 3 trial in endometrial cancer until its completion.
analyzed safety data 1-month post treatment of all patients randomized in the trial.
determined that the first dose of the vaccine is well tolerated in adults, adolescents and children, some of whom were pre-exposed to dengue viruses.
support received to proceed to third patient cohort (n=4, dose level 2)
In our research centre, the DSMB
play a crucial role in nephrology clinical research, protecting participant safety and clinical research integrity.
After the third planned analysis, the DSMB
concluded that the trial was
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "We are obviously disappointed with the outcome of the interim analysis as reported to us by the DSMB
, both from a patient and Company perspective.
According to the MACSI protocol, the DSMB
reviews safety data once every 100 patients complete the study's follow-up period.
analyses, the DSMB
recommended that the trial continue as planned.
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.
No Concerns Identified; DSMB
Recommends Trial Continues as Planned