KFDA Grants IND Approval for Phase III MACSI Study of DP-b99 in Korea
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."
The MACSI protocol, published recently in the International Journal of Stroke, was agreed with the U.S. FDA under the Special Protocol Assessment (SPA) procedure and the DP-b99 development program has been granted Fast Track status by the U.S. FDA. In the MACSI study, DP-b99 is being tested for safety and for the ability to improve outcome in moderately severe acute ischemic stroke patients. A total of 770 patients will be recruited. The primary objective is to evaluate the safety and therapeutic effects of intravenous 1.0mg/kg/day DP-b99, initiated within nine-hours of stroke onset in patients with moderately severe hemispheric acute ischemic stroke. The primary efficacy outcome is the modified Rankin Scale (mRS) score at day 90 which will be compared between treatment groups using a 'shift', or distribution, analysis.
DP-b99 is a unique broad-spectrum neuroprotective drug that addresses an array of brain damaging processes occurring in stroke patients. Both preclinical and clinical Phase I and II studies indicate a favorable efficacy and safety profile for DP-b99. In the Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window.
D-Pharm (http://www.dpharm.com) is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics, and has generated a rich pipeline of patent protected proprietary products. D-Pharm's pipeline includes advanced clinical stage products, DP-b99 for treatment of ischemic stroke patients and DP-VPA, a novel drug for treatment of epilepsy, bipolar disorder and prophylaxis of migraine. DP-VPA, is in Phase II clinical development. DP-460 is in preclinical development intended as an oral, disease-modifying therapy for Alzheimer's disease. Other mimics of bioactive lipids, LipidoMimetix, are at an earlier developmental stage for cancer.
Statements in this press release that are not historical facts are forward-looking information, as defined in the Securities Law, based on information available to D-Pharm at the time of this press release. The estimations could, some or all, be unrealized, or could be realized in significantly different ways than expected.
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SOURCE D-Pharm Ltd