Cytomedix Announces Expansion of Phase 2 Study to Treat Post-Acute Ischemic Stroke at Up to 15 U.S. Clinical Sites

GAITHERSBURG, MD--(Marketwire -05/16/12)- Cytomedix, Inc. (OTC.BB: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, announced that the independent Data Safety Monitoring Board (DSMB) reviewing the safety data from the ongoing RECOVER-Stroke trial has recommended that the Phase 2 trial of ALD-401, a unique and differentiated stem cell population derived from patients' own bone marrow, can continue as designed. This determination follows a review of the clinical safety data on the first 10 patients that were treated post-acutely for ischemic stroke.

The double-blind, placebo-controlled trial of 100 patients is designed to assess the safety and efficacy of ALD-401 to improve clinical outcomes in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of between 7 and 22 when administered between 13 and 19 days post the ischemic event. The primary endpoint of the study is safety and the secondary efficacy endpoint is neural function based on the modified Rankin Scale assessed at three months following treatment.

Currently being conducted at three clinical sites, the trial will now expand up to a total of approximately 15 U.S. clinical sites with this clearance by the DSMB. The study has gained Investigation Review Board ("IRB") approval from a number of leading healthcare institutions under the guidance of key opinion leaders in the field of ischemic stroke. Additional DSMB reviews are scheduled at 30 and 60 patients per the clinical protocol.

Commenting on the clearance to continue the Phase 2 trial, Martin P. Rosendale, Chief Executive Officer, stated, "We are very encouraged by the decision of the DSMB to recommend the continuation of the RECOVER-Stroke trial and look forward to expanding this important trial to additional leading stroke clinical sites across the U.S. The only currently approved treatment options (tissue plasminogen activator (tPA) and mechanical retrievers) must be used within a very short time frame from the onset of the stroke. Consequently, less than 5% of stroke patients receive any approved treatments. ALD-401 is being delivered to patients suffering from the often devastating effects of ischemic stroke approximately two weeks following the stroke.

"Strokes remain one of the leading causes of long-term disability. With the majority of strokes occurring in patients 65 years and older, it is also a major financial burden for our healthcare system. Preclinical research with ALD-401 has shown improvements in motor function, in mitigation of the decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow in the brain. We are hopeful that ALD-401 will continue to demonstrate these regenerative activities in this trial and look forward to advancing its clinical development," added Mr. Rosendale.

"We are grateful to our early investigators, which include the University of Texas Health Science Center at Houston, Duke University Medical Center, and the Los Angeles Brain and Spine Institute, for their support and guidance through the early enrollment of this trial. We also look forward to working with a number of premier academic and private health leaders as we expand the study. Importantly, we want to recognize the care and thoughtful guidance received from our independent DSMB," commented James Hinson, M.D., Cytomedix' Chief Medical Officer. "We just concluded an Investigator's Meeting and were especially pleased and encouraged to see the underlying enthusiasm for this potential treatment option among leading clinicians in stroke treatment and research."

About Stroke

According to the American Stroke Association, stroke is a disease that affects the arteries leading to and within the brain. It is the fourth leading cause of death and a leading cause of disability in the United States. A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts. When that happens, part of the brain cannot get the blood and oxygen it needs, so it starts to die. Strokes are typically classified into two major categories: ischemic and hemorrhagic. Approximately 800,000 patients in the United States suffer a stroke each year and approximately 87% of these strokes are ischemic.

About ALD-401

ALD-401 is the population of ALDHbr stem cells produced using Cytomedix' proprietary technology to sort a specified quantity of bone marrow collected from the patient receiving the therapy. These adult stem cells express high levels of the enzyme ALDH, and preclinical research suggests that they 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 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.

Cytomedix Announces Expansion of Phase 2 Study to Treat Post-Acute Ischemic Stroke at Up to 15 U.S. Clinical Sites

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