Aldagen Announces FDA Clearance of IND to Begin Phase 2 Study in Ischemic Stroke
News Jan 05, 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.
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE