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),
and Craig Hospital (
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@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@proneuron.com;
Marjie@netvision.net.il;
+972-55-365-220