[Proneuron1] Experimental ProCord Procedure now available in New York & New Jersey

Tue Dec 7 01:58:40 PST 2004

PRONEURON'S PHASE II EXPERIMENTAL PROCORD PROCEDURE FOR COMPLETE SPINAL CORD
INJURY NOW AVAILABLE AT THE MOUNT SINAI MEDICAL CENTER IN NY & UNIVERSITY
HOSPITAL IN COLLABORATION WITH KESSLER INSTITUTE FOR REHABILITATION IN NJ

ProCord is an experimental procedure involving specially treated white
blood cells (macrophages) injected into the damaged spinal cord of a patient

Newark, NJ and NY, NY, December 7, 2004 --- Proneuron Biotechnologies
(www.proneuron.com) announced today that The Mount Sinai Medical Center and
University Hospital in collaboration with Kessler Institute for
Rehabilitation are now enrolling patients as treatment sites in the Phase II
study of ProCord for complete spinal cord injury. University Hospital
patients will receive post-procedure rehabilitation at Kessler Institute for
Rehabilitation in West Orange, NJ. Patients enrolled at the New York site
will receive all procedures at The Mount Sinai Medical Center. Progenitor
Cell Therapy, LLC (PCT, Hackensack, NJ) will provide the required cell
processing facility for the manufacturing of ProCord for both sites. The
Mount Sinai Medical Center and Kessler Institute for Rehabilitation became
referral sites in June 2004.

"There are two classifications for sites participating in the ProCord study,
treatment and referral. The Principal Investigators at the treatment sites
are specifically trained and have been well prepared to surgically inject
the experimental ProCord into a patient's injured spinal cord. Treatment
sites also either have a specially designed ProCord cell processing center
in house or located reasonably close in proximity. Referral sites actively
screen patients into the study and provide rehabilitation management for
those referrals who have been accepted into the trial. Both are crucial
functions to conducting a thorough and scientifically sound investigation.
We are proud to be working with all of the esteemed sites in the ProCord
study network," said Dr. David Snyder, V.P. of Clinical Development at
Proneuron. 

Following most types of tissue injury, white blood cells called macrophages
quickly start to remove cell debris. These macrophages then secrete growth
factors that help begin the healing process and promote regeneration. While
this process occurs effectively in most tissues including peripheral nerves,
it does not occur effectively in the spinal cord. Discoveries in
pre-clinical trials by Professor Michal Schwartz of Israel's Weizmann
Institute of Science suggest however that specially treated macrophages
promote recovery from spinal cord injury. Based on these findings, Proneuron
is evaluating the safety and efficacy of ProCord in human trials. ProCord
consists of macrophages isolated from the patient's own blood, activated
through Proneuron's proprietary process, and then injected directly into the
patient's injured spinal cord. 

This international, multi-center, randomized-controlled, experimental study
is open to patients who meet eligibility criteria, including but not limited
to an ASIA Grade A injury between C5-T11 vertebrae, within 14 days of
injury. ASIA Grade A is defined as patients who have no feeling or movement
below the point of injury. 

Patients found eligible for the study will be randomly assigned to either a
treatment or control group, two treatment patients for every one control
patient, on average. Control patients will not receive the procedure. All
control and treatment patients will receive standard spinal cord injury
rehabilitation and will receive follow-up testing for one year. Trial site
investigators need to be notified of a potential candidate within a few days
of his or her spinal cord injury in order to give ample time for patients to
be evaluated and potentially participate in the 14-day window of the
clinical trial.
Other treatment sites include: Craig Hospital in Denver, Colorado, Shriners
Hospitals for Children, Philadelphia and Chaim Sheba Medical Center in
Israel. Shepherd Center in Atlanta, GA, anticipated to become a treatment
site in early 2005, is already taking an active role in the study as a
referral and rehabilitation center. For a complete list of sites please
visit: www.spinalcordtrial.com.

PATIENT, IMMEDIATE FAMILY OF PATIENT AND/OR PHYSICIAN INQUIRIES:
24 hour a day Patient Recruitment Center:
E-mail: 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 the U.S., please use standard international dialing code
For additional information: www.proneuron.com

FOR ADDITIONAL INFORMATION: 

Marjie Hadad, Media Liaison, Proneuron, Marjie.hadad at proneuron.com,
+972-54-536-5220.

Debra Kaplan, Associate Director of External Relations, The Mount Sinai
School of Medicine, 212-659-9045 or debra.kaplan at mssm.edu

Robin Preisler, Executive Director, Marketing and Media Relations,
University Hospital, preislro at umdnj.edu,  (973)972-6273.

Gail Solomon, Director of Corporate Communications, Kessler Institute for
Rehabilitation, 973-243-6879; pager 973-705-6813, or
gsolomon at kessler-rehab.com

George S. Goldberger, Chief Business Officer, PCT,
ggoldberger at progenitorcell.net or 201-883-5314.