[Proneuron1] Phase I ProCord Study Results Published J. Neurosurgery: Spine, September 2005 Issue

[proneuron1 at list.proneuron.com]

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

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 at 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 at proneuron.com.