LOS ANGELES & WEST ORANGE, N.J.--(BUSINESS WIRE)--Oct. 8, 2003--
Principal Investigators Meeting Held at the Kessler Institute for Rehabilitation in N.J.
Proneuron Biotechnologies (www.proneuron.com), a leader in the development of medical treatments for spinal cord injuries and other disorders of the central nervous system, announced today the completion of its three-day investigator's meeting of its IND Phase II study of macrophage therapy (ProCord) for the treatment of acute complete spinal cord injury. The principal investigators, along with key participants from the clinical centers, met at Kessler Institute for Rehabilitation in West Orange, NJ, for instruction on the implementation of the clinical protocol and training of the clinical specialists who will assess the study endpoints.
As of now, the treatment is provided at Sheba Medical Center in Israel, the first of five locations to host this study. Craig Hospital in Denver, Colorado, Principal Investigator, Dr. Daniel P. Lammertse, is soon to enroll patients. Following the necessary approvals, Mount Sinai Hospital in NYC, Principal Investigator, Dr. Kristjan Ragnarsson; Shepherd Center in Atlanta, GA, Principal Investigator, Dr. David Apple; and Kessler Institute for Rehabilitation in West Orange, NJ, Principal Investigator, Dr. Steven Kirshblum, will also be enrolling patients.
"By bringing together the medical science, the technology and the clinical insight of researchers and physicians, the ProCord project offers great potential in advancing the care and treatment of individuals with acute spinal cord injury," noted Dr. Steven Kirshblum, Associate Medical Director/Director of Spinal Cord Injury Services, Kessler Institute for Rehabilitation. "It was an honor for Kessler to host this important meeting of the Phase II investigators and we look forward to collaborating with our colleagues across the country and around the world on this exciting project."
The meeting sessions included a review of the scientific rationale and proof of concept pharmacology studies, Phase I safety and efficacy results, the Phase II protocol, the role and responsibilities of the Independent Data Monitoring Committee and the 24-hour call center and patient recruitment flow. "The Principal Investigators' meeting was productive and informative. All involved are now well versed and ready for the next steps. It is our hope that ProCord will continue to produce promising results and in turn begin to fill an unmet clinical need. In the meantime, I would like to emphasize that investigators must be notified of a patient within a few days of the injury and that ProCord must be administered within 14 days of the injury," said Dr. David Snyder, V.P. Clinical Development at Proneuron.
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 a proprietary technology for modulating the interaction between the nervous and the immune systems. The company is currently engaged in several clinical studies in the U.S., Belgium and Israel. These include: a trial of Macrophage therapy (ProCord) 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, indications that are being independently developed by Proneuron. Proneuron is also developing PN277 for the reatment of additional neurodegenerative diseases. 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.
Contacts
Proneuron Biotechnologies, Inc.
Marjie Hadad, +972-55-365-220
Marjie.hadad@proneuron.com