Proneuron Biotechnologies, a developer of treatments for spinal cord injuries and other central nervous system (CNS) disorders, today announced it had begun enrolling patients in a phase II clinical trial of ProCord.
ProCord is a macrophage therapy for the treatment of patients with acute complete spinal cord injury (SCI) within 14 days of damage. Macrophages, the key component of the therapy, are types of white blood cells that crawl around in the body’s extracellular fluids, eating up microbes and other foreign material.
ProCord consists of macrophages isolated from the patient's own blood, activated through a proprietary process and then injected directly into the patient's injured spinal cord.
According to Proneuron, macrophages are quickly mobilized and begin removing cell debris following tissue injury. The macrophages then begin to secrete growth factors that promote a controlled inflammatory reaction, the initial phase of the wound healing process. While this process normally occurs in most tissues, including peripheral nerves, it does not occur in the CNS, including the spinal cord, says Proneuron.
Discoveries in pre-clinical studies, led by Prof. Michal Schwartz of the Weizmann Institute of Science, have shown that specially-treated macrophages promote recovery from spinal cord injury. Proneuron says that based on the findings, it is now developing ProCord as a clinical product to treat spinal cord injured patients.
Initially the treatment will be provided at Sheba Medical Center in Israel, the first of five locations to host this study.
Following the necessary approvals, three additional sites located in the US will also enroll patients. These are: Craig Hospital in Denver, Colorado; Mount Sinai Hospital in NYC; and Kessler Institute for Rehabilitation in West Orange, NJ. A fifth site will be named later.
"The Phase I studies in Israel and Belgium treated patients worldwide. These studies showed positive results in an encouraging number of the patients; from complete loss of feeling and movement to recovery of some feeling and movement below the level of injury… We hope that this current trial will lead to additional positive results that will ultimately enable us to offer a valuable treatment to patients," said Dr. Nachshon Knoller, principal investigator at Sheba Medical Center in Israel.
In the US alone, there are an estimated 11,000 new spinal cord injuries (SCI) per year, says Proneuron. Causes include motor vehicle accidents, acts of violence, falls, sports and other occurrences. SCI trauma usually results in significant morbidity, including respiratory failure, bladder and bowel dysfunction, and complete loss of motor function.
The Phase II study will include 61 patients between the ages of 16 and 65 years old, all with complete spinal cord injury.
"ProCord must be administered within 14 days of the injury. Therefore, it is crucial that the investigators in this trial are notified of a potential candidate within a few days of the incident in order to give ample time for Proneuron to conduct its proprietary procedures using the patient's own blood," said Dr. David Snyder, VP, Clinical Development at Proneuron. "We hope that ProCord will continue to deliver promising results and ultimately fill a major unmet clinical need."
Proneuron is privately held and based in Ness Ziona, Israel. The company is currently engaged in several clinical studies in the US, Belgium and Israel, including a trial of Cop-1 for the treatment of Huntington's disease (HD). In 2001, Proneuron entered into a strategic collaboration with Teva to develop and commercialize Cop-1 for various indications other than HD and Amyotrophic Lateral Sclerosis (Lou Gehrig's Disease), which are being independently developed by Proneuron. Proneuron is also developing PN277 for the treatment of additional neurodegenerative diseases.
Published by Globes [online] - www.globes.co.il - on 23 September, 2003