Cerevast Therapeutics, Inc. Announces Outcome Of First Interim Analysis Of Phase 3 CLOTBUSTER Trial For The Treatment Of Acute Ischemic Stroke
REDMOND, Wash., Sept. 23, 2014 /PRNewswire/ -- Cerevast Therapeutics Inc., a privately held medical technology company, announced today the outcome of the first interim analysis of its ongoing Phase 3 clinical trial evaluating the Company's proprietary Clotbust ERTM ultrasonic headframe for the treatment of acute ischemic stroke. The independent Data Safety Monitoring Board (DSMB) has recommended the trial continue enrollment as planned.
"Clearing the pre-specified futility threshold and four independent safety reviews represents a significant step towards the continued advancement of Cerevast's Clotbust ER as a potential new therapy for stroke patients," said Andrei V. Alexandrov, M.D., Professor and Chairman of the Department of Neurology at the University of Tennessee Health Science Center in Memphis and Global PI for the CLOTBUSTER study.
The first interim analysis was conducted on 250 randomized patients. The primary efficacy endpoint of the analysis was 90-day functional recovery as measured by the modified Rankin Scale (mRS) a validated and widely used clinical outcome measure for stroke clinical trials. Upon completion of the analysis, the DSMB instructed Cerevast to continue enrollment in the clinical trial without modification to the study protocol.
"We are pleased with the DSMB recommendation to continue enrollment in the clinical study without modification," said Bradford A. Zakes, Chief Executive Officer at Cerevast. "With over fifty percent of the required subjects for the study now enrolled, we look forward to reaching the second interim analysis as our next major milestone."
The CLOTBUSTER Phase 3 clinical study is a randomized, double-blind trial evaluating the efficacy and safety of the Clotbust ERTMultrasound device when used in combination with standard intravenous thrombolytic therapy (tissue plasminogen activator - tPA/Alteplase). The study is designed to randomize up to 800 evaluable ischemic stroke patients on a 1:1 basis to either Clotbust ERTM ultrasound in combination with IV tPA therapy or standard IV tPA therapy alone. In addition to evaluating 90-day functional recovery as the primary efficacy endpoint, the study measures the incidence of symptomatic intracranial hemorrhage (sICH) as the primary safety endpoint. The study also evaluates complete vessel recanalization as a secondary endpoint in a subset of patients that undergo pre and post-treatment MRI or CT angiography. The trial is being conducted at over 60 leading stroke centers in 14 countries worldwide.
To date over 460 subjects have been randomized in the study. The second interim analysis will be conducted after 90-day functional recovery data has been collected on approximately 540 subjects. Prior to performing the first interim analysis, the DSMB conducted four separate un-blinded safety reviews after 50, 100, 200 and 300 subjects had been enrolled. Following each safety review, the DSMB instructed Cerevast to continue enrollment without modification to the study protocol.
Approximately 795,000 strokes occur in the United States each year. Stroke represents the third leading cause of death in the United States and is the leading cause of serious long-term disability, currently impacting over three million Americans with an economic burden to the U.S. healthcare system of greater than $73 billion dollars each year. tPA remains the only FDA approved treatment for ischemic stroke. Based on the limited treatment options, ischemic stroke is recognized worldwide as a significant unmet medical need.
About Clotbust ERTM
Clotbust ERTM is a first-in-class ultrasound device for the treatment of ischemic stroke, representing a novel product with the potential to serve as the most significant advancement in stroke care since tPA was approved in 1996. Designed for rapid deployment in the emergency room setting, the device has been engineered to non-invasively deliver therapeutic ultrasound energy to the region of the occluded vessel in the brain. Clinical data from five independent studies has demonstrated that combining the acoustic energy of ultrasound with conventional intravenous (IV) tPA therapy dissolves blood clots more completely and provides patients with better long term clinical outcomes compared to IV tPA therapy alone. Based on the results of these studies, the Clotbust ERTMreceived European CE mark clearance in December 2011.
About Cerevast Therapeutics, Inc.
Cerevast Therapeutics, Inc. is a late-stage medical technology company focused on the development of SonoLysis for the treatment of acute ischemic stroke and other vascular disorders. Cerevast is a recognized leader in the field of SonoLysis with a dominant intellectual property estate comprising more than 75 issued patents. The Company is a privately held corporation based in Redmond, Washington. For more information, visit www.cerevast.com.
SOURCE Cerevast Therapeutics, Inc.