Phase II Trials of ProCord

Published: January 1, 2004
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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.

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.

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”.

“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.

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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: [email]clinical.trial@proneuron.com[/email]; 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. -Thanks to Kenny Hosack for info