Aastrom Announces Results of Two Studies of Ixmyelocel-T Published in Stem Cell Research & Therapy
ANN ARBOR, Mich., Nov. 1, 2013 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that results from two separate research studies involving ixmyelocel-T, the company's lead product candidate, were published in the peer reviewed journal Stem Cell Research & Therapy.
Results from the first study, "Ixmyelocel-T, an Expanded Multicellular Therapy, Contains a Unique Population of M2-Like Macrophages", show that ixmyelocel-T contains M2-like macrophages characterized by expression of multiple, well-known M2 macrophage markers, decreased secretion of pro-inflammatory cytokines after inflammatory stimuli, and efficient removal of apoptotic cells. The population of macrophages generated in ixmyelocel-T is believed to play a role in tissue repair and regeneration.
"Our data demonstrate that ixmyelocel-T therapy contains a unique population of M2-like macrophages characterized by secretion of anti-inflammatory cytokines and expression of M2 markers CD206 and CD163. In addition to being involved in efficient removal of apoptotic cells, they also show elevated expression of MerTK, which is essential in limiting tissue injury and promoting repair. These findings provide further indication that these cells may play a key role in the treatment of diseases where tissue remodeling and immunomodulation are components of successful clinical outcomes," said Dr. Ronnda Bartel, chief scientific officer, Aastrom Biosciences. "We believe that this research also represents the first successful ex-vivo expansion of these anti-inflammatory cells."
In the second study, titled "Potential Beneficial Effects of Ixmyelocel-T in the Treatment of Atherosclerotic Diseases", ixmyelocel-T was treated with modified low-density lipoprotein (LDL) similar to that found in atherosclerotic plaques. The amounts of LDL uptake and expression of cytokines and key cholesterol transport genes were then measured in an attempt to mimic the pro-inflammatory environment in atherosclerotic lesions. The results of these analyses showed that ixmyelocel-T macrophages are able to influx modified cholesterol, remain anti-inflammatory in the face of lipid loading and inflammatory challenge, and display enhanced cholesterol efflux capabilities.
"This study indicates that the unique M2-like population of macrophages found in ixmyelocel-T is efficient at maintaining cholesterol homeostasis. As a result, ixmyelocel-T macrophages may exert highly beneficial effects and represent a potential new modality in the treatment of atherosclerotic disease," Dr. Bartel said.
Ixmyelocel-T is a patient-specific multicellular therapy expanded from a patient's own bone marrow. It is currently being evaluated in a Phase 2b clinical trial for treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The Phase 2a trial in DCM patients confirmed that ixmyelocel-T was well-tolerated and that efficacy observations were consistent with improved function of impaired myocardium. Health Canada recently approved the company's application to initiate this clinical trial in Canada. Aastrom is also continuing to follow patients treated in the REVIVE Phase 3 clinical trial of ixmyelocel-T in the treatment of critical limb ischemia. Preclinical studies of ixmyelocel-T are in progress in atherosclerosis and fibrosis. Researchers at the University of Michigan are also studying the use of ixmyelocel-T in the treatment of craniofacial augmentation. Ixmyelocel-T is manufactured using Aastrom's proprietary, highly automated, fully closed cell-processing system.
About Aastrom Biosciences
Aastrom Biosciences is the leader in developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases. The company's proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into late-stage clinical development, including a Phase 2b clinical trial in patients with advanced heart failure due to ischemic dilated cardiomyopathy. For more information, please visit Aastrom's website at www.aastrom.com.
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