D-Pharm Ltd., announced that the Data and Safety Monitoring Board (DSMB) for the Membrane Activated Chelator Stroke Intervention (MACSI) study recommended that the study continue as planned. The DSMB conducted a comprehensive unblinded review of safety data from the first 200 patients that completed follow-up in the MACSI study, as well as a review of all Serious Adverse Event (SAE) data from previous DP-b99 clinical studies.
In the phase III MACSI study, DP-b99 is being tested for safety and for the ability to improve outcome in moderately severe acute ischemic stroke patients.
Dr Alex Kozak, D-Pharm’s CEO commented; “The outcome of this in depth safety review by an unblinded, unbiased team of independent experts is most reassuring and I’m delighted that the MACSI study can continue uninterrupted.”
According to the MACSI protocol, the DSMB reviews safety data once every 100 patients complete the study’s follow-up period. Additionally, the DSMB has reviewed data across the whole development program of DP-b99. The DSMB, which includes independent experts in stroke neurology and biostatistics, has recommended to the MACSI Steering Committee that the study continue in its present design without changes to the protocol. According to plan, the DSMB will next meet upon completion of enrollment and follow-up of the first 300 patients in the study.
The MACSI study is one on the largest randomized, double blind, placebo-controlled phase III stroke studies currently ongoing. Its 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 mRS score at day 90 which will be compared between treatment groups using a ‘shift’, or distribution, analysis.
The MACSI study is enrolling 770 patients, with recruitment in up to 170 clinical sites in North America, Europe, South America, South Africa and Israel. The protocol, published recently in the International Journal of Stroke, was agreed with the US FDA under the Special Protocol Assessment (SPA) procedure and the DP-b99 development programme has been granted Fast Track status by the US FDA.
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.
Every year around 1.5 million people in the US, Western Europe and Japan suffer an acute stroke. Stroke is a leading cause of death in the western world and around 50% of stroke survivors suffer from some form of severe disability. According to the American Heart Association (AHA) the annual economic burden of stroke in the US was around $ 70B in 2009. Currently, between 2-5% of stroke patients receive tissue plasminogen activator (tPA), the only drug currently approved for treatment of acute stroke in the US.
D-Pharm is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics, and has generated a rich pipeline of patent protected proprietary products.