CYTOMEDIX ANNOUNCES EXPANSION OF PHASE 2 STUDY TO TREAT POST-ACUTE ISCHEMIC STROKE AT UP TO 15 U.S. CLINICAL SITE
CYTOMEDIX ANNOUNCES EXPANSION OF PHASE 2 STUDY TO TREAT POST-ACUTE ISCHEMIC STROKE AT UP TO 15 U.S. CLINICAL SITES
ALD-401 Phase 2 Study Clears Safety Assessment for First 10 Patients by DSMB
GAITHERSBURG, Md. (May 16, 2012) – 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.”
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 an autologous regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair. 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 and 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 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 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 ALD-401’s continuing to demonstrate regenerative capabilities in these upcoming trials, the Company’s ability to successfully manage and advance clinical development of ALD-401, the likelihood of positive reviews at 30 and 60 patient thresholds, the Company’s continuing ability to successfully integrate the Aldagen acquisition and underlying technologies the sustained interest and demand for the ALD-401 treatment option among stroke clinicians, 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.
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
(240) 499-2680 (212) 838-3777