Phase I ProCord Study Results Published in the Journal of Neurosurgery: Spine September 2005 Issue

L.A., California, September 12, 2005 --- Proneuron Biotechnologies (www.proneuron.com) announced today the publication of the results of the first ProCord study in the September issue of the Journal of Neurosurgery: Spine in an article titled Clinical Experience using Autologous Incubated Macrophages as a Treatment for Complete Spinal Cord Injury-Phase I Study Results. Journal subscribers can access the article on-line at www.thejns-net.org .

The FDA-sanctioned study was an uncontrolled, Phase I clinical trial designed to assess the safety and tolerability of ProCord (autologous incubated macrophages), an experimental immune cell therapy. The article documents the results of eight acute spinal cord injury patients treated at Chaim Sheba Medical Center Israel, and followed for a year thereafter. ProCord proved to be well tolerated, with no observed side-effects. Preliminary efficacy results were also generated.

Patients were enrolled in the study within 14 days of their injury, and were evaluated accordingly with the American Spinal Injury Association (ASIA) scale. All eight were assessed as ASIA A, meaning complete loss of feeling and movement below the point of injury. Three of these patients recovered some feeling (ASIA B); and went on to recover limited movement below the level of injury (ASIA C).

“Overall, the study…represents a small, although potentially promising Phase I safety study. Although the conversion from ASIA A to C status in three patients is encouraging, one needs to exercise caution when interpreting the results obtained in an unblinded pilot study. Nonetheless, it is encouraging that the patients appeared to tolerate the treatment well without evidence of neurological deterioration,” wrote Michael G. Fehlings, MD, PhD, FRCSC in the editorial that precedes the article. Dr. Fehlings is a Professor of Neurosurgery, Krembil Chair in Neural Repair and Regeneration, McLaughlin Scholar in Molecular Medicine, University of Toronto, Chair, Spinal Cord Injury Committee, Section of Neurotrauma and Critical Care, American Association of Neurological Surgeons and Congress of Neurological Surgeons."

Besides the initial eight patients presented in this article, eight other patients have now been treated with ProCord, as part of a Phase I extension study and a Phase Ib study conducted in Belgium. The results of these additional studies further support the favorable safety profile of ProCord.

“The ProCord trial is truly a unique study, as it is currently the only advanced clinical investigation of an immune cell therapy proposed as a treatment for complete spinal cord injury where the endpoint is the assessment of functional progress. Though we are still early in the research, the initial results are encouraging enough for us to continue focusing our energies in this direction,” said Dr. Nachshon Knoller, Neurosurgeon, Head of Spinal Surgery Unit, Department of Neurosurgery, Chaim Sheba Medical Center, the Principal Investigator of the ProCord trial in Israel and one of the authors of the article.

Several scientists and physicians involved in the clinical trial and/or the development of Procord also contributed to the writing of the article, including Professor Michal Schwartz of the Weizmann Institute of Science. Professor Schwartz was the first to propose that immune cells could stimulate wound-healing in an immune privileged area like the central nervous system.

Procord is an experimental procedure that involves isolating immune cells called macrophages (a special type of white blood cell) from the patient’s blood, co-incubating them with a segment of autologous skin tissue, and then surgically injecting the resulting ProCord directly into the spinal cord, below the point of injury. ProCord, which received FDA orphan drug designation status in September 2004, is currently being studied in a Phase II, international, multi-center randomized-controlled clinical trial. Patients found eligible for the study are randomly assigned to either a treatment or non-treatment control group, two treatment patients for every control patient. Control patients will not receive the procedure. All treatment and non-treatment control patients receive standard spinal cord injury rehabilitation and follow-up testing for one year. Qualifying patients must be referred within 12 days of their injury in order to meet the 14-day study protocol window. For a full list of participating sites, please visit www.spinalcordtrial.com .

Patient, Immediate Family of Patient and/or Physician inquiries:

24 hour a day Patient Recruitment Center:

Email: clinical.trial@proneuron.com  
Telephone: 1-866-539-0767 (U.S. toll free) or 1-506-652-3486.
Fax: 1-866-214-7078

*Callers outside of the U.S., please use standard international dialing codes.

For complete details about the study: www.spinalcordtrial.com  or www.proneuron.com .


Press inquiries: Marjie Hadad, Media Liaison, Proneuron, +972-54-536-5220 or Marjie.hadad@proneuron.com .