GAITHERSBURG, MD--(Marketwire - Dec 6, 2012) - Cytomedix, Inc. (
The Phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC. The primary endpoints of the study are safety and the change in peak walking time at 6 months compared to baseline. Additionally, changes in leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging (MRI) will be examined. These novel MRI techniques are incorporated into the study to assess perfusion, providing a unique set of data potentially supporting the angiogenic mechanism of Bright Cells. The clinical study has received Investigational New Drug approval from the U.S. Food and Drug Administration (FDA) and is expected to begin enrollment in Q1 2013 upon the Investigational Review Board approvals from the participating centers.
Martin P. Rosendale, Chief Executive Officer of Cytomedix, stated, "We are delighted that the CCTRN has chosen to collaborate with Cytomedix on this study. Our February acquisition of Aldagen and the Bright Cell technology has positioned us well to play a leading role in investigating promising clinical paths in regenerative medicine where there exists significant unmet medical need. We look forward to supplying a highly differentiated personalized cell therapy product to the participating CCTRN centers involved with this important PAD indication. Intermittent claudication is a serious consequence of arteriosclerosis which, if left untreated, will likely progress to pain at rest and possibly open wounds. Our experience with the AutoloGel product and the clinical treatment of lower extremity wounds resulting from CLI has provided us with a full appreciation of the difficult clinical outcomes associated with this compromised patient population. We are hopeful that improvements in lower leg blood flow will lead to increased peak walking time which has been accepted as an FDA approvable endpoint in pivotal Phase 3 trials in IC."
"This is the first randomized clinical trial to look at the benefits of autologous stem cell therapy in PAD patients with IC. It will collect important mechanistic and clinical information on the efficacy and safety of the direct injection of Bright Cells into these patients. It will also evaluate the utility of advanced imaging endpoints that could be used in the future to further understand the impact of novel therapies in this patient population," added Lem Moyé, M.D., Ph.D., professor of biostatistics at the University of Texas School of Public Health, Houston, and co-author of the study protocol.
PAD is a major unmet medical need affecting approximately 8 to 10 million patients in the U.S. IC is a significant subset of the PAD population and is characterized by pain in the lower legs while in motion that resolves upon rest. Critical limb ischemia (CLI) is the advanced form of PAD, and is associated with poor clinical outcomes and increased morbidity. An important goal of medical intervention is to attempt to prevent the progression of patients from IC to CLI. This clinical study builds on the strong data showing increased blood flow and improved clinical status from Cytomedix's previous Phase 1/2 study of ALD-301 in CLI published last year ("A Randomized, Controlled Study of Autologous Therapy with Bone Marrow-Derived Aldehyde Dehydrogenase Bright Cells in Patients with Critical Limb Ischemia" Catheterization and Cardiovascular Interventions 2011). In the PACE study, ALD-301 will be delivered in the same manner, via direct, intramuscular injection in a grid pattern of the affected lower limb. Cytomedix will be responsible for manufacturing ALD-301 for the clinical trial and will have certain rights to data generated during the trial.
About ALD-301/ALDH Bright Cells
ALD-301 is a population of autologous pluripotent stem cells isolated from the patients' bone marrow using Cytomedix' proprietary Bright Cell technology. These adult stem cells express high levels of the enzyme ALDH, an indicator of biological activity in heterogeneous early stage stem cells. Preclinical research suggests that ALD-301 may promote the repair of ischemic tissue damage by producing signaling molecules that are involved in cell recruitment, cell adhesion, and angiogenesis.
About Cardiovascular Cell Therapy Research Network (CCTRN) and NHLBI
The CCTRN includes seven main stem cell centers in the United States with experience and expertise in clinical trials studying treatments for cardiovascular diseases. They are the Texas Heart Institute, the University of Florida at Gainesville, Minneapolis Heart Institute, Stanford University, University of Louisville, University of Miami and the Vascular and Cardiac Center for Adult Stem Cell Therapy in Indianapolis, Indiana. The CCTRN has successfully completed and published the results of three adult stem cell trials to date (TIME, LateTIME, and FOCUS). Further information on CCTRN is available at: cctrn.org.
The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health. NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available at: nhlbi.nih.gov.
About Cytomedix, Inc.
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for 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® cPRP System, a blood processing device and disposable products used for the separation of blood and bone marrow 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 technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit 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.