Their agreement to the protocol attests to the adequacy of the MACSI
trial design, and confirms that the MACSI
results, if positive, will be able to support a New Drug Application submission.
According to the MACSI protocol, the DSMB reviews safety data once every 100 patients complete the study's follow-up period.
The MACSI study is one on the largest randomized, double blind, placebo-controlled Phase III stroke studies currently ongoing.
The MACSI study is enrolling 770 patients, with recruitment in over 100 clinical sites in North America, Europe, South America, South Africa and Israel.
According to the MACSI protocol, a Data Safety Monitoring Board (DSMB), should periodically review safety data from patients enrolled into the study.
The forthcoming Phase III trial will be performed according to GCP and ICH guidelines in parallel with the MACSI trial.
D-Pharm's Phase III trial, MACSI, will enroll 770 moderate to severely affected ischemic stroke patients worldwide.
study is enrolling 770 patients, with recruitment ongoing at many, of over 100, clinical sites in North America, Europe, South America, South Africa, Israel and South Korea.
Alex Kozak, D-Pharm's CEO commented: "Success of the study in Asian volunteers and extension of MACSI
to South Korea is of strategic value, paving the way for DP-b99 to reach vast Asian markets.
Micro Warehouse began in 1987 and installed Smith-Gardner's MACSI
to automate its U.
study is as international, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial.
TASE: DPRM) announced today that the interim report for the DP-b99 MACSI
study is expected in February, 2012.