Proneuron Biotechnologies will initiate a second Phase 1 clinical trial of autologous activated macrophage therapy for patients with paralysis resulting from complete spinal cord injury. This trial will be conducted at the Erasme Hospital in Brussels, 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 FDA Investigational New Drug Application.

The new study will involve approximately eight adults with complete spinal cord injury in a spinal segment from C6 to T11, and who can be treated within three weeks of injury.

“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,” said CEO Dr. Valentin Fulga of clinical trials to date.

The use of autologous activated macrophages for nerve regeneration is based on technology developed in the laboratory of Prof. Michal Schwartz of the Weizmann Institute of Science and licensed to Proneuron. 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 essential to 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) macrophages directly from the blood, activating them in the laboratory and then implanting them in the site of the injury.