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Shepherd Center And Proneuron Biotechnologies, Inc. (US Branch) Receive $3.2 Million Commitment From The For Phase II Study Of ProCord, An Experimental Procedure For Acute Spinal Cord Injury


10/19/2005 5:10:21 PM

ATLANTA & LOS ANGELES--(BUSINESS WIRE)--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 ( www.proneuron.com ) and the Shepherd Center ( 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 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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