PRONEURON STARTS 2ND PHASE 1 SPINAL CORD INJURY CLINICAL TRIAL.

Proneuron Biotechnologies, Ness-Ziona, Israel, a privately held company, has initiated a second Phase 1 clinical trial of autologous activated macrophage therapy for patients with complete spinal cord injury. This trial will be conducted at the Erasme Hospital in Brussels, Belgium with the approval of the Hospital's Ethics Committee and after notification of the Belgian Ministry of Health, and is designed to assess the safety of autologous activated macrophage therapy. The new study is intended to complement and extend the observations in the company's first Phase 1 trial, conducted in Israel under a US Food and Drug Administration Investigational New Drug Application with the approval of the Israel Ministry of Health.

The first study is designed to study approximately eight complete spinal cord injury patients and follow their post-treatment course for one year or longer. "We are nearing completion of the enrollment phase of our first clinical trial. To date, we have been pleased by the safety of this therapy and encouraged by positive therapeutic outcomes," said Dr. Valentin Fulga, senior vice president of Development at Proneuron. "Although it is too early to make definitive statements, we have observed positive clinical outcomes in terms of sensory and motor improvement in patients who by definition have a very poor prognosis in recovery from their paralysis. The availability of a second clinical site in Brussels will make it easier to enroll patients throughout Europe and expand our Phase 1 patient population."

The principal investigator of the clinical trial will be Prof. Jacques Brotchi, chairman of the Department of Neurosurgery at the Erasme Hospital. According to Prof. Brotchi, "Patients with complete spinal cord injury have a poor chance of functional recovery. We are pleased to be able to participate in a clinical trial with an innovative cellular therapy that has shown promise in preclinical and early clinical studies." The new Belgian cell-processing center will operate in collaboration with the Unit of Cellular and Molecular Therapy (UTCM) headed by Prof. Michel Goldman.

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 administering activated macrophages.

Macrophages are white blood cells that play a beneficial role in wound healing and tissue regeneration throughout the body. However, within the brain and spinal cord, resident macrophage activity appears to be inhibited, severely restricting the capacity for spontaneous regeneration. The strategy employed by Proneuron is to overcome the restriction on nerve regeneration by collecting autologous (taken from the patient himself) macrophages directly from the blood, activating them in the laboratory and then implanting them in the site of the injury. 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.

In the new Belgian study, adults with a complete spinal cord injury in a segment from C6 to T11, and who can be treated within three weeks of their injury, may be eligible if they meet specified inclusion criteria. Macrophages are harvested from the patient, activated in a special facility and implanted surgically by the neurosurgeon. Following this procedure, patients will be intensively followed with safety monitoring and periodic assessments of neurological, radiographic and electrophysiological parameters. If results of the initial studies support additional clinical testing, a Phase 2 study will be initiated.

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.