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Ed Note: The following is
a press release from Proneuron and the Shepherd Center
March 9, 2004
Proneuron to Establish Cell Center in Atlanta to Support Shepherd's
Participation in this International, Multi-center, Randomized-controlled
Trial
Proneuron Biotechnologies ( http://www.proneuron.com/ ) and the Shepherd
Center ( http://www.shepherd.org/ ) announced today the receipt of a $3.2
million commitment by The Marcus Foundation. The commitment will help
finance the establishment of a cell-processing center in Atlanta and to
support Shepherd Center's participation in Proneuron's international,
multi-center, randomized-controlled Phase II study of ProCord, an
experimental procedure for acute spinal cord injury.
"We have been following the development of this experimental procedure,
ProCord, for more than a year and feel confident that the collaboration
between Shepherd and Proneuron will significantly contribute to the further
advancement of this research," said Bernie Marcus chairman of The Marcus
Foundation.
Shepherd Center is one of the world's leading centers for the treatment of
traumatic spinal cord and brain injuries. Each year, Shepherd Center sees
more newly injured spinal cord and brain injury patients than any other
hospital in the U.S. Since its founding in 1975, Shepherd Center has been
guided by a mission to help improve the lives of people who have experienced
catastrophic injuries of the central nervous system.
"This is the most exciting research project in which Shepherd Center has had
the opportunity to participate," said David Apple, Jr., MD, medical director
of Shepherd Center.
The Phase II trial commenced at Sheba Medical Center in Tel Hashomer,
Israel, in September 2003 and expanded to the U.S. at Craig Hospital in
Denver three months later in December. Following the necessary approvals,
The Mount Sinai Medical Center in NY and Kessler Institute for
Rehabilitation in West Orange, NJ will also begin to study this experimental
procedure in 2004.
"In line with our mission, Shepherd Center is committed to building the
capacity to become one of the first sites in the world to participate in
cutting edge research, including nerve cell regeneration, neurosurgical
advances, and innovative rehabilitation therapies," said Michael Jones, PhD,
vice president of research at Shepherd Center.
"We are delighted to be working with the Shepherd Center and of course we
are grateful to the Marcus Foundation for helping to make this liaison
possible. Together with the research teams at Craig Hospital, Shepherd
Center, The Mount Sinai Medical Center and Kessler Institute for
Rehabilitation, we hope to make great strides in the understanding of the
effects of ProCord, with the goal of developing this currently experimental
procedure for spinal cord injury patients worldwide," said Mr. Nir Nimrodi,
CEO of Proneuron.
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 central nervous system (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 currently evaluating the
safety and efficacy of ProCord, autologous incubated macrophages, in humans
in clinical trials. 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.
This experimental study is open to patients who meet eligibility criteria,
including but not limited to ASIA Grade A, C5-T11, within 14 days of injury.
This is a randomized-controlled clinical trial. 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. It is crucial that trial site 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.
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
Shepherd Center in Atlanta is the country's largest catastrophic care
hospital specializing in the treatment of people with spinal cord injury and
disease, acquired brain injury, multiple sclerosis and other neuromuscular
disorders and urological problems. Shepherd Center is the largest Model
Center for spinal cord injury in the country, serves as one of the largest
brain injury programs in Georgia, and is an official Multiple Sclerosis
Center, designated the National Multiple Sclerosis Society--Georgia Chapter.
Founded in 1975, the 100-bed not-for-profit hospital offers a continuum of
health care services, from intensive care through inpatient medical surgical
care, rehabilitation, day program, and outpatient and residential services.
For more information, visit http://www.shepherd.org/.
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 immune systems. The company's products are currently being evaluated in
several clinical studies located in the U.S., Belgium and Israel. These
include: an independently managed, international, multi-center,
randomized-controlled Phase II trial of ProCord, autologous incubated
macrophages, an experimental procedure for spinal cord injuries and a Phase
II program of Cop-1 for the treatment of Huntington's disease (HD), Glaucoma
and other neurodegenerative diseases. The latter is being managed by Teva as
part of the Proneuron's strategic collaboration for development and
commercialization of Cop-1 for various neurodegenerative indications. The
Company is also developing PN277 for the treatment of additional
neurodegenerative diseases.
Contacts
Proneuron Biotechnologies (Press)
Marjie Hadad, +972-55-365-220
Marjie.hadad@proneuron.com
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