Athersys, Inc., an international biotechnology company, focuses primarily in the field of regenerative medicine. The company engages in the discovery and development of therapies designed to extend and improve the quality of human life. The company has established a portfolio of therapeutic product development programs to address significant unmet medical needs in multiple disease areas. The company’s MultiStem cell therapy, a patented and proprietary allogeneic stem cell product, is the company’s major platform product and in later-stage clinical development. The company’s clinical development programs are focused on treating neurological conditions, cardiovascular disease, inflammatory and immune disorders, certain pulmonary conditions and other conditions. These represent major areas of clinical need, as well as substantial commercial opportunities. Programs The company’s programs in the clinical development stage include the following: Ischemic Stroke: The company completed its Phase 2 study of MultiStem treatment of subjects suffering a moderate to severe ischemic stroke. In 2015, the company announced the interim results from the clinical study, and in 2016, it announced the one-year follow-up data from the study. Analysis of biomarker data obtained from samples of study subjects indicated that MultiStem treatment reduces post-stroke inflammation compared to placebo, and it appears that this effect is more pronounced for subjects receiving MultiStem earlier than 36 hours post-stroke. This effect is consistent with its hypothesis regarding mechanisms of action and related preclinical data, and with the clinical data suggesting faster recovery for MultiStem-treated patients. Further analyses are being undertaken, and the company is preparing for the next stage of clinical development of this program. Acute Myocardial Infarction (AMI): The company initiated a Phase 2 clinical study in the United States for the administration of MultiStem cell therapy to patients that have suffered an AMI. It previously evaluated the administration of MultiStem to patients that suffered an AMI in a Phase 1 clinical study. The results of this study demonstrated a favorable safety profile and encouraging signs of improvement in heart function among patients that exhibited severely compromised heart function prior to treatment. The company is enrolling patients in its Phase 2 clinical study, evaluating the safety and efficacy of MultiStem treatment in subjects who have a non-ST elevated myocardial infarction. The study is double-blind, sham-controlled and is being conducted at major cardiovascular centers in the United States. Acute Respiratory Distress Syndrome (ARDS): The company has also initiated a clinical study for the treatment of ARDS in the UK and in the United States. ARDS is a serious immunological and inflammatory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, or other trauma and represents a major cause of morbidity and mortality in the critical care setting. The Phase 2a clinical trial is being conducted with the assistance of Catapult and is currently enrolling patients. Hematopoietic Stem Cell Transplant/graft-versus-host disease (GvHD): The company completed a Phase 1 clinical study of the administration of MultiStem cell therapy to patients suffering from leukemia or certain other blood-borne cancers in which patients undergo radiation therapy and then receive a hematopoietic stem cell transplant. Such patients are at significant risk for serious complications, including GvHD, an imbalance of immune system function caused by transplanted cells that trigger an attack against various tissues and organs in the patient. The company is granted orphan drug designation by the United States Food and Drug Administration (FDA) and the the European Medicines Agency (EMA) for MultiStem treatment in the prevention of GvHD. In 2015, the MultiStem product was granted Fast Track designation by the FDA for prophylaxis therapy against GvHD following hematopoietic cell transplantation. Subsequently, its registration study design received a positive opin
(ATHX:Consolidated Issue listed on NASDAQ Capital Market)
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