GAITHERSBURG, MD--(Oct 11, 2012) - 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.
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.
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
About Cytomedix, Inc.
Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel™ System, cleared by the FDA for wound care and the Angel® Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit www.cytomedix.com.
Safe Harbor Statement
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2011 and other subsequent filings. These filings are available at www.sec.gov.
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SOURCE: Cytomedix, Inc.