MOUNT OLIVE, N.J., Oct. 2, 2017 /PRNewswire/ -- Flowonix Medical, Inc. and Cerebral Therapeutics, Inc. announced today the successful implant of the fifth patient in the ADDRESS (Australian Direct Drug Administration for Refractory Epilepsy) trial. The jointly developed therapy features a micro-infusion device which tightly controls drug delivery to a region of the brain for patients with medically refractory epilepsy.
"The study investigators are very encouraged with the results of the ADDRESS trial thus far," stated Professor Mark Cook, Chair of Medicine and Director of Neurosciences at St. Vincent's Hospital in Melbourne, Australia. "With each day that passes, our clinical teams, the patients enrolled in the trial, and the patients' families and friends are seeing the types of improvements that get the medical community excited about an investigational therapy."
ADDRESS is the first prospective dose ranging study assessing intra-cerebroventricular (ICV) delivery of Valproate in patients with focal seizures, with temporal lobe onset with or without secondary generalization. In December 2016, the first patient was implanted in the trial, and she continues to receive the therapy today. Additional patients continue to be enrolled in the study in Australia.
"As a leader in the field of implantable targeted drug delivery, we are excited about the early successes in the ADDRESS trial," stated Larry Heaton, President and CEO, Flowonix Medical, Inc. "We are thrilled to be a part of this first-of-a-kind therapeutic advancement with our partners at Cerebral Therapeutics, and we hope this is the start of a long partnership that improves the lives of thousands of patients suffering from neurological disorders."
The epileptic therapy being evaluated in the ADDRESS trial includes an abdominal implant of the Prometra® II Programmable Pump with a catheter tunneled under the skin to the brain. The pump delivers Cerebral Therapeutics' medication from the pump through a tunneled catheter directly into the ventricle in the brain, thereby bypassing the blood-brain barrier.
"Though we are still early in the development of this epilepsy treatment, it is rewarding to know that there are now five patients who have had the opportunity to benefit from the therapy," stated Dan Abrams, M.D., CEO, Cerebral Therapeutics. "We look forward to enrolling additional subjects in our Australian study sites prior to turning our focus to gaining FDA approval in order to offer this therapy to Americans suffering from refractory epilepsy. As we look out even further, we believe direct-to-brain administration may offer hope for a variety of other neurological disorders, including Parkinson's, Post-Traumatic Stress Disorder, Glioblastoma, and Alzheimer's."
About the Prometra® II Programmable Infusion System
The Prometra Programmable Infusion System is FDA approved for intrathecal infusion of Infumorph® (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP). The Prometra II Pump is not approved for the ICV administration of Valproate in the USA or Australia, and is being studied as an investigational use only device in Australia.
About Flowonix
Flowonix Medical Inc. (www.flowonix.com), headquartered in Mt. Olive, New Jersey, is working with healthcare professionals to help ease suffering associated with chronic pain and enabling patients to improve their lives through innovation and therapy advancements. Our goal is to become the leading implantable drug delivery company in the world. Founded in 2005, Flowonix is working closely with physicians to enhance the capabilities of implantable drug delivery systems. For more information, please visit http://www.flowonix.com
About Cerebral Therapeutics
Cerebral Therapeutics, LLC (www.cerebraltherapeutics.com) is a privately-held company founded with the goal of addressing the well-recognized limitations of existing treatments for uncontrolled neurological diseases. Cerebral Therapeutics is combining advanced micro-dosing technology with proprietary medications to precisely deliver treatments to the other side of the blood-brain barrier to improve the lives of patients with uncontrolled neurological disease. With a promising route of administration, Cerebral Therapeutics offers a new approach to managing neurological diseases by means of delivering ideal dosing to targeted sites within the brain. Initially, Cerebral Therapeutics is focused on improving outcomes and propagation in the brain. Future cerebral therapeutic areas include obesity, Alzheimer's disease, Parkinson's disease, anxiety spectrum disorder, and brain cancer.
FLOWONIX and PROMETRA are registered trademarks of Flowonix Medical, Inc.INFUMORPH is a registered trademark of West-Ward Pharmaceuticals.
For more information contact:
Jeff ColellaFlowonix Medical, [email protected]
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"The study investigators are very encouraged with the results of the ADDRESS trial thus far," stated Professor Mark Cook, Chair of Medicine and Director of Neurosciences at St. Vincent's Hospital in Melbourne, Australia. "With each day that passes, our clinical teams, the patients enrolled in the trial, and the patients' families and friends are seeing the types of improvements that get the medical community excited about an investigational therapy."
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ADDRESS is the first prospective dose ranging study assessing intra-cerebroventricular (ICV) delivery of Valproate in patients with focal seizures, with temporal lobe onset with or without secondary generalization. In December 2016, the first patient was implanted in the trial, and she continues to receive the therapy today. Additional patients continue to be enrolled in the study in Australia.
"As a leader in the field of implantable targeted drug delivery, we are excited about the early successes in the ADDRESS trial," stated Larry Heaton, President and CEO, Flowonix Medical, Inc. "We are thrilled to be a part of this first-of-a-kind therapeutic advancement with our partners at Cerebral Therapeutics, and we hope this is the start of a long partnership that improves the lives of thousands of patients suffering from neurological disorders."
The epileptic therapy being evaluated in the ADDRESS trial includes an abdominal implant of the Prometra® II Programmable Pump with a catheter tunneled under the skin to the brain. The pump delivers Cerebral Therapeutics' medication from the pump through a tunneled catheter directly into the ventricle in the brain, thereby bypassing the blood-brain barrier.
"Though we are still early in the development of this epilepsy treatment, it is rewarding to know that there are now five patients who have had the opportunity to benefit from the therapy," stated Dan Abrams, M.D., CEO, Cerebral Therapeutics. "We look forward to enrolling additional subjects in our Australian study sites prior to turning our focus to gaining FDA approval in order to offer this therapy to Americans suffering from refractory epilepsy. As we look out even further, we believe direct-to-brain administration may offer hope for a variety of other neurological disorders, including Parkinson's, Post-Traumatic Stress Disorder, Glioblastoma, and Alzheimer's."
About the Prometra® II Programmable Infusion System
The Prometra Programmable Infusion System is FDA approved for intrathecal infusion of Infumorph® (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP). The Prometra II Pump is not approved for the ICV administration of Valproate in the USA or Australia, and is being studied as an investigational use only device in Australia.
About Flowonix
Flowonix Medical Inc. (www.flowonix.com), headquartered in Mt. Olive, New Jersey, is working with healthcare professionals to help ease suffering associated with chronic pain and enabling patients to improve their lives through innovation and therapy advancements. Our goal is to become the leading implantable drug delivery company in the world. Founded in 2005, Flowonix is working closely with physicians to enhance the capabilities of implantable drug delivery systems. For more information, please visit http://www.flowonix.com
About Cerebral Therapeutics
Cerebral Therapeutics, LLC (www.cerebraltherapeutics.com) is a privately-held company founded with the goal of addressing the well-recognized limitations of existing treatments for uncontrolled neurological diseases. Cerebral Therapeutics is combining advanced micro-dosing technology with proprietary medications to precisely deliver treatments to the other side of the blood-brain barrier to improve the lives of patients with uncontrolled neurological disease. With a promising route of administration, Cerebral Therapeutics offers a new approach to managing neurological diseases by means of delivering ideal dosing to targeted sites within the brain. Initially, Cerebral Therapeutics is focused on improving outcomes and propagation in the brain. Future cerebral therapeutic areas include obesity, Alzheimer's disease, Parkinson's disease, anxiety spectrum disorder, and brain cancer.
FLOWONIX and PROMETRA are registered trademarks of Flowonix Medical, Inc.INFUMORPH is a registered trademark of West-Ward Pharmaceuticals.
For more information contact:
Jeff ColellaFlowonix Medical, [email protected]
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SOURCE Flowonix Medical Inc.
