CYTOMEDIX ANNOUNCES PUBLICATION IN AMERICAN HEART JOURNAL HIGHLIGHTING POSITIVE PHASE I CLINICAL DATA USING ALD-201 TO TREAT ISCHEMIC HEART FAILURE
GAITHERSBURG, Md. (March 15, 2012) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that positive data from a Phase 1 clinical trial of ALD-201 to treat ischemic heart failure were published in the March 2012 online edition of the American Heart Journal. In the study, ALD-201 was considered safe and demonstrated initial evidence of improved blood flow and improved clinical status. ALD-201 is a population of biologically instructive adult stem cells (aldehyde dehydrogenase bright cells, or ALDHbr) that are selected from the patient’s own bone marrow using the ALDH enzyme as a marker.
The article is entitled, “Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase–bright stem cells in patients with ischemic heart failure.” The abstract may be accessed online at: http://www.ahjonline.com/article/S0002-8703(11)00878-7/abstract.
The randomized, double-blind, placebo-controlled Phase 1 study included 20 heart failure patients with no treatment options. The primary end point was safety and secondary end points included several well-accepted clinical measurements. The patients received either an injection of ALD-201 directly into the heart muscle, or an injection of an equivalent volume of placebo using the same catheter delivery system. Investigators assessed patients for endpoints for the first six months after the injection and then followed them for an additional six months.
In the study ALD-201, including injection into the myocardium, was considered to be safe and well tolerated. After six months, the subjects who received ALD-201 demonstrated an improvement in MaxVO2, a measure of the body’s ability to take up oxygen during exercise, while the placebo group did not. These findings support the ability of ALDHbr cells to promote angiogenesis and restore blood flow to the ischemic heart muscle.
Commenting on the results of the Phase 1 study, Principal Investigator, Emerson C. Perin, M.D., Ph.D., Director of the Stem Cell Center at the Texas Heart Institute at St. Luke's Episcopal Hospital, and the Adult Cardiology Texas Heart Institute at St. Luke's Episcopal Hospital in Houston, noted, “The preliminary evidence suggests improved perfusion and a trend toward improved functional capacity in no-option heart failure patients treated with ALDHbr cells. Importantly, we presented a unique approach for selecting a diverse population of active cells for cell therapy by using a physiologic rather than a single phenotypic marker, which may result in the isolation of a more efficacious population comprising the multiple cell types required for ischemic repair.”
“We are very encouraged by these positive data as they corroborate both the preclinical research and other clinical studies that suggest ALDHbr cells specifically migrate to sites of ischemic damage and induce the formation of new blood vessels at those sites,” noted Martin P. Rosendale, Chief Executive Officer of Cytomedix. “We look forward to continuing to advance our development efforts with this very promising regenerative technology platform in a number of important clinical indications, including ischemic stroke for which we are currently in Phase 2 clinical trials.”
About Ischemic Heart Failure
Ischemic heart failure is caused by a reduction of blood flow to the muscles of the heart, which is most commonly caused by an obstruction of the arteries feeding blood to the heart tissue. As a result, the insufficient provision of oxygen and nutrients reduces the heart’s ability to pump blood efficiently to the rest of the body. Current treatment options for ischemic heart failure include surgical procedures, bi-ventricular pacers, drug therapies, implantable cardiac defibrillators, and ventricular assist devices. For some patients, these treatments are not effective or appropriate. Once ischemic heart failure patients have exhausted all potential revascularization options, their only other option is a heart transplant, if they are eligible.
About Cytomedix, Inc.
Cytomedix, Inc. develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit www.cytomedix.com
Safe Harbor Statement
Statements contained in this communication 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 many among others, risks and uncertainties related to the Company’s ability to successfully integrate this 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 intergrated 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, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
Cytomedix, Inc. Investor Inquiries
Martin Rosendale, Chief Executive Officer Anne Marie Fields
Andrew Maslan, Chief Financial Officer LHA
David Jorden, Executive Chairman (email@example.com
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