Cerevast Therapeutics, Inc. Initiates Phase 3 Clotbust ER™ Clinical Study for the Treatment of Acute Ischemic Stroke
Published: Aug 01, 2013
REDMOND, Wash., Aug. 1, 2013 /PRNewswire/ -- Cerevast Therapeutics, Inc., a privately-held medical technology company, announced today that it has initiated patient enrollment in its Phase 3 clinical trial evaluating the use of the Company's proprietary Clotbust ERTM ultrasonic headframe for the treatment of acute ischemic stroke. This worldwide study intends to enroll up to 800 ischemic stroke patients in a randomized, double-blinded clinical trial designed to evaluate the efficacy and safety of the Clotbust ERTMultrasound device when used in combinationwith standard intravenous thrombolytic therapy (tissue plasminogen activator - tPA/Alteplase).
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.
"Initiation of the Clotbust ER Phase 3 study represents a significant milestone for Cerevast," said Bradford A. Zakes, Chief Executive Officer. "Clinical data in over 200 subjects has demonstrated that the addition of transcranial ultrasound to conventional IV tPA therapy has a favorable safety profile and results in significant improvements in vessel recanalization and 90-day clinical outcomes in ischemic stroke patients when compared to IV tPA therapy alone. We believe that this Phase 3 clinical study will further demonstrate the therapeutic potential of this proprietary technology as we continue to advance the Clotbust ERTM ultrasound device towards commercial approval in the U.S."
The Clotbust ER Phase 3 clinical study is being conducted at over 60 leading stroke centers in 14 countries worldwide. The trial will enroll ischemic stroke patients with baseline National Institute of Health Stroke Scale (NIHSS) scores of 10 or greater. Patients will be randomized (400 per arm) to either Clotbust ERTM ultrasound in combination with IV tPA therapy or standard IV tPA therapy alone. The primary endpoint of the study is 90-day functional outcome as measured by the percentage of patients that achieve a modified Rankin (mRS) score of 0-1 at 90 days post-treatment. The study will also evaluate complete vessel recanalization as a secondary endpoint in a subset of patients that undergo pre and post-treatment MRI or CT angiography. Two interim analyses are scheduled to be performed by the study's Data Safety Monitoring Board (DSMB) upon completion of one-third and two-thirds of enrollment.
"The body of clinical evidence demonstrating the clinical utility of transcranial ultrasound as a means of effectively augmenting conventional IV thrombolysis therapy for the treatment of acute ischemic stroke has been steadily increasing over the past several years," said Andrei Alexandrov, M.D., Professor of Neurology, Director, UAB Comprehensive Stroke Research Center and Global PI for the Clotbust ER study. "Based on strong interest level from the medical community, we are fortunate to have many of the world's leading stroke centers participating in this pivotal Phase 3 study to conclusively demonstrate the therapeutic benefit of this therapy and positively impact the future of emergency stroke treatment."
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.
"The medical community is eager to obtain access to new technologies to improve the outcomes of patients that are affected by the devastating effects of ischemic stroke," said Carlos Molina, M.D., Professor and Director of Neurology, Vall d'Hebron Hospital and Chairman of the Steering Committee for the Clotbust ER study. "There have been very few treatment advances since tPA was originally approved in the U.S. in 1996. If validated in this Phase 3 clinical study, the Clotbust ERTMwill serve as a major advancement in stroke care, providing clinicians with a new and novel treatment option to improve the clinical outcomes of stroke patients worldwide."
About Cerevast Therapeutics, Inc.
Cerevast Therapeutics, Inc. is a 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, and an extensive data package of pre-clinical and clinical studies. The Company is a privately held corporation headquartered in Redmond, WA. For more information, visit www.cerevast.com.
About SonoLysis Therapy
SonoLysis is the term used to describe the application of ultrasound energy to disrupt or "lyse" blood clots in the vasculature. In the setting of acute ischemic stroke, clinical studies have demonstrated that the combination of transcranial ultrasound with conventional thrombolytic therapy results in a significant improvement in both vessel recanalization and rate of complete recovery compared to conventional thrombolytic therapy alone a major advance in treatment.
About the Clotbust ERTM
The Clotbust ERTM is a first-in-class ultrasound device for the treatment of ischemic stroke that utilizes multiple transducers incorporated into a unique, operator-independent headframe. The Clotbust ERTM is designed to self-align the transducers based on common landmarks on the skull. Proprietary software controls the ultrasound parameters, which in turn allows the device to deliver consistent therapeutic levels of ultrasound energy necessary to enhance clot lysis within targeted regions of the brain without the need for a trained sonographer or vascular technician to perform the procedure.
For additional information, please contact:
Bradford A. Zakes
Chief Executive Officer
Phone: (206) 769-9219
SOURCE Cerevast Therapeutics, Inc.
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