[Proneuron1] Proneuron Biotechnologies Inc. -- Hot News

Tue Sep 23 01:46:49 PDT 2003

Proneuron Biotechnologies Announces a Phase II IND Study

 of Macrophage Therapy (ProCord) for the Treatment of Complete Spinal Cord Injury 

Study investigators must be notified of a patient within a few days of injury

Los Angeles, CA and Ness Ziona, Israel, September 23, 2003 --- Proneuron Biotechnologies (www.proneuron.com), a leader in the development of medical treatments for spinal cord injuries and other disorders of the central nervous system, announced today it is now enrolling patients in a Phase II clinical trial of ProCord.  ProCord consists of autologous activated macrophage therapy for the treatment of patients with acute complete spinal cord injury (SCI) within 14 days of damage. 

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.

Following tissue injury, a type of white blood cell, called a macrophage, is quickly mobilized, and starts to remove cell debris. 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.  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 SCI. Based on these findings, Proneuron is now developing ProCord as a clinical product to treat spinal cord injured patients.  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. 

“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; i.e., American Spinal Injury Association (ASIA) grade A to ASIA grade B or ASIA grade C status.  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 U.S. alone, there are an estimated 11,000 new spinal cord injuries per year.  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 (ASIA grade A).  The trial will be a multi-center, randomized-control trial.  Controlled assessments will be made at six and 12 months.

“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, V.P., Clinical Development at Proneuron. “We hope that ProCord will continue to deliver promising results and ultimately fill a major unmet clinical need.”

About Proneuron Biotechnologies

Proneuron Biotechnologies, Inc. is a privately held biopharmaceutical company developing products for the medical treatment of spinal cord injuries and other disorders of the central nervous system.  Its products are based on a proprietary technology for modulating the interaction between the nervous and the immune systems. The company is currently engaged in several clinical studies in the U.S., Belgium and Israel.  These include: a trial of Macrophage therapy (ProCord) for the treatment of spinal cord injuries and 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 ALS, which are being independently developed by Proneuron. Proneuron is also developing PN277 for the treatment of additional neurodegenerative diseases.  

Patient, Immediate Family of Patient and/or Physician inquiries: 24 hour a day Call Center in the U.S.: 1-866-539-0767; Fax number: 1-866-214-7078. *Callers outside of the U.S., please use standard international dialing codes. 

Press inquiries: Marjie Hadad, Marjie.hadad at proneuron.com; Marjie at netvision.net.il; 

+972-55-365-220
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