Aldagen Announces FDA Clearance of IND to Begin Phase 2 Study in Ischemic Stroke With Regenerative Cell Therapy
First Stem Cell Therapy to Be Administered in a Clinical Study Approximately Two Weeks After the Stroke
DURHAM, NC--(Marketwire - January 5, 2011) - Aldagen, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to conduct a clinical trial using Aldagen's ALD-401, a unique stem cell population, for the treatment of stroke patients. It will be the first U.S. clinical trial in stroke patients to study a unique stem cell population as a regenerative therapy given two weeks after the stroke.
"We are excited to begin our first clinical stroke study. Stroke represents the leading cause of disability in the U.S. and the third leading cause of morbidity. The only product currently available for stroke treatment is an anti-clotting agent that must be administered within three hours of onset of the stroke. Because of this timing requirement, less than 5% of stroke patients
receive the treatment. ALD-401 will be delivered about two weeks after a stroke and therefore has the potential to treat a large group of patients who have no therapeutic options," said Lyle A. Hohnke, Ph.D., Chief Executive Officer of Aldagen.
The Phase 2 trial is designed to assess the safety of ALD-401 and its potential efficacy to improve clinical outcomes in patients with ischemic strokes when administered 13 and 19 days after the stroke. The trial size will be approximately 100 patients, with roughly 60% receiving an injection of ALD-401 into the carotid artery. Aldagen will perform its initial clinical study in a relatively homogenous population of stroke patients. Therefore, only patients with unilateral cortical ischemic strokes will be eligible to participate in the Phase 2 clinical trial. In addition, the patient must have an NIH stroke scale score between 7 and 22 prior to treatment.
Strokes are characterized by the rapidly developing loss of brain function due to a significant diminution in the blood supply to the brain. Strokes are typically classified into two major categories, ischemic and hemorrhagic. Ischemic strokes result from an inadequate supply of blood and oxygen to the brain due to blockage of an artery, such as by a blood clot, while hemorrhagic strokes result from rupture of a blood vessel or an abnormal vascular structure. The American Heart Association estimates that approximately 800,000 patients in the United States suffer a stroke each year, approximately 87% of strokes are ischemic, and the mean lifetime cost of ischemic stroke in the United States is approximately $140,000.
ALD-401 is the population of stem cells produced using Aldagen's proprietary technology to sort a specified quantity of bone marrow collected from the patient receiving the therapy. Preclinical research suggests that these stem cells may promote the repair of ischemic tissue damage. This is tissue damage caused by inadequate blood flow resulting from the obstruction of blood vessels supplying blood to the tissue. Investigators have completed preclinical research in which ALD-401 was administered two weeks after a stroke. This preclinical research showed improvements in motor function, improvements in the slowing of decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow, or perfusion, in the brain.
Aldagen is a clinical-stage biopharmaceutical company developing proprietary regenerative cell therapies. Our product candidates consist of a specific population of a patient's own stem cells, which are isolated using our proprietary technology and which we believe have the potential to promote the regeneration of multiple types of cells and tissues, including the growth of new
blood vessels. Our initial focus is on developing product candidates to address cardiovascular disease. Our clinical stage cardiovascular product candidates are ALD-301 for the treatment of critical limb ischemia, ALD-201 for the treatment of ischemic heart failure, and ALD-401 for the post-acute treatment of ischemic stroke.