GAITHERSBURG, MD -- (Marketwire) -- 10/11/12 -- Cytomedix, Inc. (OTCQX: CMXI) (the "Company"), a leading developer of biologically active regenerative therapies, today announced that safety data from the first 10 patients in the Phase II RECOVER-Stroke study of ALD-401, a unique and differentiated stem cell population derived from patients' own bone marrow, are being presented today at the World Stroke Congress in Brazil. This initial part of the study, primarily designed to assess the safety of ALD-401, showed no severe adverse events. The study was expanded to a target enrollment of 100 patients following a review of these initial data by an independent Data Safety Monitoring Board (DSMB) earlier this year.
The study data are being presented today by Sean Savitz, M.D., professor of neurology and director of the stroke program at the University of Texas Health Science Center at Houston (UTHealth). Ten patients who had suffered MCA ischemic stroke were enrolled and randomized to one of two groups: 1) a bone marrow harvest followed by intra-carotid infusion of purified ALDHbr cells or 2) a sham harvest followed by sham angiography. As this is the only randomized, double-blind, intra-arterial stem cell trial of its kind in the world, patients were monitored very closely for any adverse effects. Safety of the procedure was assessed by laboratory studies, neurological examinations and serial neuroimaging. No serious adverse events were reported. Data on ALDHbr cells will be presented at the meeting.
The ongoing expanded Phase II RECOVER-Stroke trial will enroll an additional 90 patients at up to 15 U.S. clinical sites. It 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. 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.
"The World Stroke Congress is a great opportunity for Dr. Savitz to introduce ALD-401 to a wide audience of clinicians," stated Martin P. Rosendale, Chief Executive Officer of Cytomedix. "Patients currently have very limited treatment options which are only useful within a very short time frame from the onset of the stroke. With ALD-401 we are developing a novel treatment that may provide therapeutic benefit two weeks after the initial event. The expanded RECOVER-Stroke trial is designed to give us more insight into the product's safety and efficacy."
The 8th World Stroke Congress is taking place Oct 10th - 13th in Brazilia, Brazil. It was established to provide leading medical professionals with the opportunity to discuss all aspects of stroke and to discover late-breaking research from world experts.
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