Currently, MACSI, a randomised, double-blind, placebo-controlled DP-b99 Phase III stroke study, is ongoing in over 150 clinical sites worldwide.
Successful completion of the safety and pharmacokinetics study allowed YJP to gain KFDA approval to participate in MACSI, D-Pharm said, adding that YJP will sponsor the Korean part of the MACSI study.
The jointclinical program includes a Phase III clinical study of DP-b99 in acutestroke patients similar to MACSI
. Wanbang will finance the first 450 patientsrecruited into the study and D-Pharm may elect to fund recruitment ofadditional patients.
The MACSI trial involves medical centers in USA, Canada, Europe, Israel, South Africa, South Korea and Brazil.
The MACSI study is as international, multicenter, randomised, double-blind, placebo-controlled Phase III clinical trial.
Service utilization and cost data were collected from the state's claims database, the Multi-Agency Community Services Information System (MACSIS
), a collaborative effort involving Ohio's departments of mental health, substance abuse, and community drug boards, via the county Alcohol and Drug Addictions Services Board (ADASB).