REHOVOT, Israel, August 24, 2011 /PRNewswire/ --
D-Pharm Ltd., (TASE: DPRM) announced today that the Korean Food & Drug Administration (KFDA) approved the Investigational New Drug (IND) application for the Phase III MACSI study of DP-b99 in Korea. The IND has been submitted by D-Pharm's co-development partner in South Korea, Yungjin Pharmaceutical Company Ltd. (YJP). Currently, MACSI, a randomized, double blind, placebo-controlled DP-b99 Phase III stroke study, is ongoing in over 150 clinical sites worldwide.
In 2006 D-Pharm granted an exclusive license to YJP to develop, register and market DP-b99 in South Korea for treatment of patients with acute ischemic stroke. To achieve KFDA approval of the IND application, YJP sponsored a pharmacokinetics and safety study of DP-b99, for the first time, in healthy Asian volunteers. The study was successfully completed early in 2011 and demonstrated no safety issues. The dosing regimen of DP-b99, intended for routine clinical use, yielded in Asian subjects a pharmacokinetic profile comparable to that in the corresponding Caucasian population. Successful completion of the safety and pharmacokinetics study allowed YJP to gain KFDA approval to participate in MACSI. YJP will sponsor the Korean part of the MACSI study.
Dr. 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."