Flowonix Medical and Cerebral Therapeutics said today that the fifth patient was successfully treated in its Address trial, which features a micro-infusion device controlling drug delivery to a particular part of the brain in patients with medically refractory epilepsy.
The study is the first of its kind, according to the companies. The Address trial is designed to evaluate intra-cerebroventricular delivery of Valproate in patients with focal seizures with temporal lobe onset, with or without secondary generalization.
The trial’s first patient was treated in December last year.
“The study investigators are very encouraged with the results of the Address trial thus far,” Mark Cook, chair of medicine & director of neurosciences at St. Vincent’s Hospital in Melbourne, Australia, said in prepared remarks. “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.”
The therapy is delivered from the Prometra II programmable pump, which is implanted in the patient’s abdomen and pumps medication directly into the ventricle of the brain through a catheter.
“As a leader in the field of implantable targeted drug delivery, we are excited about the early successes in the Address trial,” Flowonix Medical president & CEO Larry Heaton said. “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.”
“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,” Cerebral Therapeutics CEO Dr. Dan Abrams added. “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.”