[Proneuron1] Proneuron Expands Phase II Trial of ProCord to the U.S.

[Proneuron]

FOR RELEASE
Proneuron Biotechnologies Teams with Craig Hospital in Denver to Expand IND
Phase II Trial of ProCord for the Treatment of Spinal Cord Injuries to the
U.S. 
  _____  

Los Angeles, CA and Denver, CO, December 8, 2003
Proneuron Biotechnologies, Inc. (www.proneuron.com
<http://www.proneuron.com/News/NewsFiles/http//www.proneuron.com> ), and
Craig Hospital (www.craighospital.org <http://www.craighospital.org/> )
announced today that enrollment in Proneuron's IND Phase II trial of ProCord
is now open to patients at Craig Hospital in Denver, Colorado. Proneuron is
a leader in the development of treatments for patients with spinal cord
injuries and other acute and chronic disorders of the central nervous system
(CNS). Proneuron's processing Cell Center at Craig is the first U.S. site
that will test ProCord, which consists of autologous activated macrophage
therapy for a randomized controlled trial for patients with acute complete
spinal cord injury (SCI) within 14 days of injury. 

The trial commenced at Sheba Medical Center in Tel Hashomer, Israel, in
September 2003. Following the necessary approvals, three additional sites
located in the US will also study this experimental procedure including: the
Mount Sinai Medical Center in NYC; Kessler Institute for Rehabilitation in
West Orange, NJ and Shepherd Center in Atlanta, GA. This is the first step
in implementing Proneuron’s test of ProCord at multiple geographic clinical
sites in their goal to commercialize operations in North America. 


Daniel P. Lammertse, M.D., Medical Director of Craig Hospital and immediate
past president of American Spinal Injury Association, expressed optimism for
the potential of this treatment: "The Phase I trial suggests a positive
treatment effect, giving clinicians hope that this may prove to be a helpful
treatment in improving the outcomes of patients with spinal cord injury". 


Following tissue injury, a type of white blood cell, called a macrophage,
quickly starts to remove cell debris. These macrophages then start to
secrete growth factors that promote a controlled inflammatory reaction to
initiate the wound healing process. While this process occurs effectively in
most tissues including peripheral nerves, it does not occur effectively in
the CNS. Discoveries led by Prof. Michal Schwartz of the Weizmann Institute
of Science have shown in pre-clinical studies that specially treated
macrophages, however, promoted recovery from spinal cord injury (SCI). Based
on these findings, Proneuron is now developing ProCord as a clinical product
to treat patients with spinal cord injury. 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.
It is crucial that the investigators are notified of a potential candidate
within a few days of their spinal cord injury in order to give ample time
for patients to enroll and participate in the 14-day window of the clinical
trial. 


"We are honored to collaborate with Craig Hospital, one of the top treatment
centers in the world for spinal cord injury. We have established a working
relationship together in the follow-up rehabilitation of some of the
patients who participated in the Phase I trial. It is our hope that our
newly established ability to offer our experimental treatment to patients in
the U.S. will help us to better serve the patient population in the
Americas," said Proneuron's V.P. of Clinical Development Dr. David Snyder. 



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 code. 

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 proprietary technology for modulating the interaction between
the nervous and the immune systems. The company is currently engaged in
several clinical studies located in the U.S., Belgium and Israel.  These
include: a trial of Macrophage therapy 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. The Company is
also developing PN277 for the treatment of additional neurodegenerative
diseases.  


About Craig Hospital
Craig Hospital is one of the world’s leading rehabilitation and research
centers for spinal cord injury and traumatic brain injury and is designated
by the National Institute of Disability Rehabilitation & Research (NIDRR) as
a Model Systems Center for Spinal Cord Injury and Traumatic Brain Injury.
Since 1956, Craig Hospital has treated approximately 24,000 patients with
spinal cord injury and traumatic brain injury, more than any other single
U.S. facility. In 2002, Craig treated patients from all 50 states in the
U.S. 



Press inquiries: Marjie Hadad, Marjie.hadad at proneuron.com;
Marjie at netvision.net.il; +972-55-365-220 


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