GAITHERSBURG, MD -- (Marketwire) -- 12/06/12 -- Cytomedix, Inc. (OTCQX: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today the signing of an agreement with NIH to collaborate on a Phase 2 clinical study in patients with intermittent claudication (IC). IC is caused by peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles of the leg. The study is being funded by NHLBI/NIH and managed by the Cardiovascular Cell Therapy Research Network (CCTRN), which is also responsible for enrolling patients. The CCTRN is a network that includes seven centers in the United States with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases.
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.
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