OctoPlus N.V.
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Publicatie datum
27 jul 2008 - 19:40
Statutaire naam
OctoPlus N.V.
Titel
OctoPlus proves efficacy of OP-145 in Phase II ear infection study
Bericht
OctoPlus N.V. (“OctoPlus” or the “Company”) (Euronext: OCTO), the drug delivery and development company, announces today that efficacy of OP-145, a novel therapy for the treatment of chronic middle ear infection (otitis media), was demonstrated in an interim analysis of the Phase II study. As a result, OctoPlus will close the study because its goal has been achieved.
An independent Data and Safety Monitoring Board (DSMB) completed a formal interim analysis of safety and efficacy data from the Phase II study. This interim analysis shows that treatment with OP-145 is safe and effective, with statistically significant improvement of otoscopic scores. As a result, the DSMB advised OctoPlus to close the study because clinical endpoints were achieved. OctoPlus will follow the recommendation of the Board and close the study at this stage. Complete and final study results are expected to be available by the end of 2008.
Datum laatste update: 17 december 2025