LOS ANGELES & NESS ZIONA, Israel--(BW HealthWire)--Aug. 13, 2002--Proneuron Biotechnologies Inc. today announced that it has received permission from the United States Food and Drug Administration to continue the accrual of patients with complete spinal cord injury for treatment with its experimental autologous macrophage therapy.
In February 2002, Proneuron completed the enrollment of patients to its Phase 1 FDA-approved clinical trial. Follow-up assessment of the first eight treated patients is still continuing, and final results of the study will be reported during 2003.
The FDA approval to treat additional patients was granted after Proneuron submitted a comprehensive report on the interim clinical results and the manufacturing and quality control procedures. The continuation accrual plan to treat additional patients was also authorized by the ethics committee of the Sheba Medical Center where the treatments are carried out.
Dr. Valentin Fulga, Proneuron's Senior VP of Development commented, "Based on our preliminary Phase 1 results we are cautiously confident that our Autologous Macrophage Therapy is sufficiently safe for patients with complete Spinal Cord Injuries. We are happy that the FDA is allowing us to administer the experimental cellular therapy to additional patients. Treating additional patients will broaden our knowledge and experience."
Pending FDA approval, Proneuron plans to conduct the next phase of clinical trials in several centers in North America and Europe. The first center in the U.S. will be Craig Hospital, Denver, Colorado, as announced earlier this year. A second trial to test the Macrophage Therapy is currently underway in Belgium complying with European regulatory requirements.
Note: Proneuron Biotechnologies Inc. is a privately held biopharmaceutical company developing products for the treatment of spinal cord injuries and other acute and chronic disorders of the central nervous system based on proprietary technology for modulating the interaction between the nervous and the immune systems. Proneuron has recently entered in to a strategic agreement with Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) to jointly develop a therapeutic vaccination for a number of neurological diseases including spinal cord injury. For more information please visit http://www.proneuron.com.