Geron Corporation (Nasdaq: GERN) announced that the U.S. Food and DrugAdministration (FDA) has granted clearance of the company's InvestigationalNew Drug (IND) application for the clinical trial of GRNOPC1 in patients withacute spinal cord injury. The clearance enables Geron to move forward withthe world's first study of a human embryonic stem (hESC) cell-based therapyin man.
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Geron plans to initiate a Phase I multicenter trial that is designed toestablish the safety of GRNOPC1 in patients with "complete" American SpinalCord Injury Association (ASIA) Grade A subacute thoracic spinal cordinjuries. Patients eligible for the Phase I trial must have documentedevidence of functionally complete spinal cord injury with a neurologicallevel of T3 to T10 spinal segments and agree to have GRNOPC1 injected intothe lesion sites between seven and 14 days after injury.
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NEWS: World's First Study of Human Embryonic Stem Cell-Based Therapy InMan
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Contact: FOR MORE INFORMATION, PLEASE CALL: MultiVu Media Relations,1-800-653-5313 EXT. 3For more information about GRNOPC1, please visit: http://www.geron.com SATELLITE FEEDS: Friday, January 23rd, 2009 Friday, January 23rd, 2009 9:30 AM - 9:45 AM ET 1:15 PM - 1:30 PM ET Galaxy 3C Galaxy 3C C-Band C-Band Transponder 8 Transponder 8 Downlink Freq. 3860 Vertical Downlink Freq. 3860 Vertical
SOURCE Geron Corporation
