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Lawrence Wechsler, M.D.
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University of Pittsburgh to Begin Second Phase of Cell Implant Study for Stroke Patients

PITTSBURGH, March 15, 2001 — Physicians at the University of Pittsburgh Medical Center have begun the second phase of an investigational clinical research study to evaluate the safety and efficacy of implanting nerve cells to reverse the neurologic deficits of stroke patients. Layton BioScience Inc. of Sunnyvale, Ca., is sponsoring the study and manufactures the cells, called LBS-Neurons. Stanford University Medical Center also is participating in the study.

An earlier study by University of Pittsburgh researchers found that the procedure was safe and feasible and that one year after implant half of the 12 stroke patients who underwent neuronal transplantation showed improvement in motor function. PET scan images, a measurement of metabolic activity in the area of the stroke, improved in six patients.

"We are encouraged by our initial studies," said Douglas Kondziolka, M.D., professor of neurological surgery and radiation oncology at the University of Pittsburgh department of neurological surgery and principal investigator on the study. "If therapy with LBS-Neurons proves effective in improving the neurologic deficits of stroke, it would have important health, quality of life and economic benefits for thousands of people."

"The University of Pittsburgh was the first in the world to undertake this pioneering research, which has the potential to make a significant impact on the way stroke is treated in the future," said L. Dade Lunsford, M.D., Lars Leksell professor and chairman of the department of neurological surgery and co-director of the Center for Image-Guided Neurosurgery at the University of Pittsburgh School of Medicine. "It represents a major change in stroke medicine by addressing the issue of reversing neurological deficits from stroke."

Patients in the FDA-approved phase IIb study will range in age from 18 to 75 years and must have had a stroke in the basal ganglia region of the brain, between one and six years prior to the implant, that caused permanent major weakness or partial paralysis. Participants must not have other severe or uncontrolled systemic illnesses. The study is randomized and will include 18 patients. For every seven patients implanted with the nerve cells, two participants will receive no implants. All participants will receive eight weeks of rehabilitative physical therapy. In this study, seven participants will receive five million cells and seven will receive 10 million cells injected in and around the area damaged by the stroke.

"Participants in the study will be closely monitored," said Lawrence Wechsler, M.D., professor of neurology and neurosurgery at the University of Pittsburgh School of Medicine, director of the University of Pittsburgh Medical Center Stroke Institute and a co-investigator on the study. "Their neurologic status will be assessed before surgery and at numerous follow-up visits using various stroke measures. Their functional disability and quality of life also will be evaluated."

"We are delighted to be continuing to work with UPMC in the clinical development of LBS-Neurons, a novel therapy for the treatment of fixed neurologic deficit resulting from stroke," said Gary L. Snable, president and CEO of Layton BioScience Inc.

Layton BioScience is a leading neural cellular biopharmaceutical company whose mission is to develop, produce and market novel therapeutic products for the treatment of disorders of the central nervous system. It produces LBS-Neurons through a patented process that uses several chemicals to transform cells from a human teratocarcinoma into fully differentiated non-cancerous, non-dividing human neuronal cells that can be used in clinical applications. In extensive pre-clinical testing, implants of LBS-Neurons were shown to be safe and to reverse cognitive and motor deficits in animals in which stroke had been induced. The LBS-Neurons are Layton BioScience's lead product.

Stroke is the third leading cause of death and the most common cause of adult disability in the United States, according to the National Institutes of Health. Each year, 700,000 Americans suffer a stroke. Thirty percent die, and 20 to 30 percent become severely and permanently disabled. The total cost for caring for all aspects of stroke is estimated at $42 billion annually in the United States. Currently, rehabilitation through physical and occupational therapy is the only treatment available for patients with established stroke. No direct treatment is recognized as safe and effective for reversing the neurologic damage months after the event.

The procedure to implant LBS-Neurons begins with the placement of a stereotactic frame on the head of the patient. The frame is a standard tool in neurosurgery to provide a fixed way to find specific locations within the brain. The patient then receives a CT or MRI scan of the brain and the neurosurgical team makes its final decision for location of cell implantation.

Concurrently, the University of Pittsburgh immunologic monitoring and diagnostic laboratory team thaws the human neuronal cells that were frozen by and transported from Layton BioScience Inc. to Pittsburgh. In the operating room, the cells are transferred to a long-needled syringe, and using the CT scan as a guide, neurological surgeons inject the cells through a small opening in the skull to the site of the damaged brain tissue. Patients are discharged from the hospital within 24 to 48 hours.

With the start of the second phase of the study, neurological surgeons and physicians in the University of Pittsburgh Medical Center Stroke Institute are now reviewing the many hundreds of stroke patients who are on a waiting list of potential study participants.

For more information on the study, please access the web site for the University of Pittsburgh Department of Neurological surgery at http://www.neurosurgery.pitt.edu.

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