Proneuron Biotechnologies announces initiation of phase I clinical trial in complete spinal cord injury.
July 31, 2000

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NESS ZIONA, Israel,

First Patient Treated with Activated Macrophage Therapy for Nerve Regeneration.

Proneuron Biotechnologies, a privately-held company, today announced the enrollment of the first patient in a Phase 1 study to assess the safety of autologous activated macrophage therapy in the treatment of patients with complete spinal cord injury. The study, conducted in Israel under a US Food and Drug Administration Investigational New Drug Application and with the approval of the Israel Ministry of Health, is designed to study approximately eight complete spinal cord injury patients and follow their post-treatment course for one year or longer.

The use of autologous activated macrophages for nerve regeneration is based on technology developed in the laboratory of Prof. Michal Schwartz, Weizmann Institute of Science, Israel and licensed to Proneuron. Prof. Schwartz and her team study the role of immunity within the central nervous system in the development of neurological disorders. Her research has demonstrated significant recovery of neurological function in animal models of spinal cord injury by activating and administering macrophages, a type of immune cell.

Macrophages are white blood cells that play a beneficial role in wound healing and tissue regeneration throughout the body. However, within the central nervous system (CNS), macrophage activity appears to be naturally diminished and the brain and spinal cord are incapable of spontaneous regeneration. The strategy employed in this present trial is to induce nerve regeneration by enhancing the natural macrophage response in injured spinal cord tissue by directly implanting activated autologous cells (taken from the patient himself/herself). If the positive results of extensive animal experiments can be repeated in humans, the use of this therapeutic approach would be of significant clinical value even if only partial recovery can be achieved.

Dr. Nachshon Knoller, Senior Neurosurgeon, Sheba Medical Center, Tel Hashomer, Israel, a principal investigator in this study commented, "In view of the impressive published preclinical results obtained with autologous activated macrophages, I am pleased to have performed the first such human procedure to test the safety of the technique. Complete spinal cord injury is a devastating neurological condition and therapies aimed at spinal cord regeneration are vitally needed."

In the current study, adults with complete lower cervical (C5-7) or thoracic (T1-T10) spinal cord injury who meet specified inclusion and exclusion criteria are eligible if they can be treated within 14 days of their injury. Macrophages are harvested from the patient, activated in a special facility by Proneuron scientists and implanted surgically by one of the participating neurosurgeons. Following this procedure, patients will be intensively followed with safety monitoring and periodic assessments of clinical, radiographic and electrophysiological parameters. If results, which are not expected earlier than 9 to 12 months from the time of treatment, support additional clinical testing, a Phase 2 study will be initiated.

Contact Proneuron (Israel):
+972-8-940-9550
Valentin Fulga, M.D.
Senior Vice President Clinical and Regulatory Affairs

Proneuron Biotechnologies is a biopharmaceutical company developing therapeutic products for the treatment of acute and chronic diseases of the central nervous system based on proprietary technology for modulating the interaction between the nervous and the immune systems.