Eunoe Initiates Alzheimer's Disease Clinical Trial; Tampa General Hospital Begins Patient Enrollment

Business Wire, Nov 13, 2001

Business Editors and Health/Medical Writers

REDWOOD CITY, Calif.--(BW HealthWire)--Nov. 13, 2001

Eunoe Inc. today announced it has initiated a multi-center clinical trial to investigate the use of its COGNIShunt(TM) System in Alzheimer's disease patients.

The COGNIShunt System is a proprietary device designed to increase the flow of cerebrospinal fluid (CSF) and improve clearance of neurotoxins from the CSF that are believed to contribute to the progression of Alzheimer's disease. Phase I/II feasibility study results, reported at the American Association of Neurological Surgeons Conference in July 2001, indicate that COGNIShunt may slow or stop the progression of Alzheimer's disease symptoms. This pivotal Phase III trial is designed to demonstrate the safety and efficacy of COGNIShunt.

"Recent clinical research suggests that impaired clearance of extracellular fluids in the brain and the resulting accumulation of neurotoxic proteins, may play a significant role in the progression of Alzheimer's disease," said Martin Farlow, M.D., Professor of Neurology, Clinical Core Director for the Indiana Alzheimer's Center and Vice Chairman for Research in Neurology, Indiana University School of Medicine and Principle Investigator. "Current FDA-approved treatments improve symptoms but are not thought to delay the underlying progression of the disease. Eunoe's approach is a new paradigm in treating and perhaps delaying the progression of Alzheimer's disease via clearance of potentially neurotoxic cytokines and other proteins in CSF, which is naturally replaced continuously with fresh CSF. We believe this approach may improve neuronal health and survival. I'm looking forward to investigating this important new treatment approach for Alzheimer's disease patients."

The nervous system produces CSF that bathes the brain, clears products of brain cell metabolism, and provides the optimal environment for brain cell function. In normal aging, CSF production declines. In Alzheimer's disease patients, changes of normal aging may be worsened by amyloid deposition in the cells that produce and clear CSF, leading to marked CSF stagnation. The resulting accumulation of toxic substances may be a leading contributor to the progression of Alzheimer's disease.

"Our first clinical trial showed stabilization of mental function in shunted patients," said Dawn McGuire, M.D., a neurologist and President of Eunoe. "Shunts have been used for years in adults and children to treat other conditions, such as hydrocephalus. We have developed a proprietary shunt that clears a limited amount of CSF from the brain, enabling the clearance of neurotoxins. These shunt modifications are designed to significantly reduce the side effects caused by overdrainage that are typical of off-the-shelf shunts."

Eunoe plans to enroll at least 256 patients at up to 25 sites across the U.S. Nine active sites are currently enrolling subjects. These sites include: Indiana University Medical Center, Indianapolis, IN; Tampa General Hospital, Tampa, FL; Legacy Health System, Portland, OR; Scottsdale Healthcare Osborn, Scottsdale, AZ; Scripps Memorial Hospital, La Jolla, CA; Baptist Hospital East, Louisville, KY; Roger Williams Medical Center, Providence, RI; New York Methodist Hospital, Brooklyn, NY; and United Regional Healthcare System, Wichita Falls, TX.

Early data from the Eunoe Phase I/II feasibility study support that the procedure and COGNIShunt System are safe and well tolerated in Alzheimer's disease patients. In this study, 29 patients with mild to moderate Alzheimer's disease were randomly assigned to either no active treatment or shunt implantation. Data showed a marked difference in mental function over time, with better preservation of mental ability in shunted patients versus the control group. In addition, CSF levels of the potentially neurotoxic proteins found in Alzheimer's disease brain lesions, such as MAP-Tau and (beta)-Amyloid (1-42), declined in shunted patients and remained lower than their initial levels, even after twelve months. Importantly, no subject had symptoms of overdrainage, the side effect the shunt was specifically designed to avoid.

The COGNIShunt System is an implanted, flow-controlled shunt, designed to increase flow of CSF and improve clearance of potential neurotoxins from the fluid bathing the brain. The specially engineered shunt diverts CSF from the brain to the peritoneal cavity, where it is absorbed by the body. The procedure involves placing a narrow catheter into the fluid-filled cavity of the brain, allowing the controlled drainage of a small quantity of fluid into the abdomen. The surgery is conducted under general anesthesia and patients typically go home the next day or the day of the surgery.

Eunoe Inc. is a San Francisco Bay-area medical device company focused on the treatment of neurological disorders through the management of cerebrospinal fluid. The company has developed the COGNIShunt System, a device-based treatment for Alzheimer's disease, to improve clearance of neurotoxins that may be significant in the progression of Alzheimer's disease. For additional company background, please visit the Eunoe Web site at www.eunoe-inc.com.