Cleveland, OH, United States
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CLEVELAND, Feb. 23, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced today a presentation featuring its MultiStem® cell therapy treatment for ischemic stroke at the International Stroke Conference 2017 this week in Houston. Dr. Kiyohiro Houkin, Professor and Chairman at Department of Neurosurgery of Hokkaido University Graduate School of Medicine, and Director of Hokkaido University Hospital, will present an overview of the Treatment Evaluation of Acute Stroke Using Regenerative Cell Elements (TREASURE) study, which is the Phase II/III trial of MultiStem (HLCM051) being conducted by HEALIOS K.K. in Japan. Athersys and Healios entered into a license agreement in January 2016 and have been collaborating on the development and commercialization of MultiStem for the treatment of stroke in Japan. Athersys completed a Phase II clinical study (MASTERS-1) of its proprietary MultiStem cell therapy for the treatment of ischemic stroke and is currently preparing for a registrational Phase III study that will be conducted in the U.S., Europe and Canada. Dr. Houkin’s presentation entitled, Treatment Evaluation of Acute Stroke Using Regenerative Cell Elements (TREASURE): A Randomized Controlled Phase II/III Trial of MultiStem (HLCM051), will take place during the session beginning at 6:15 PM CST today at the George R. Brown Convention Center, Hall E. “We are very excited to be commencing this clinical trial at Hokkaido University Hospital and then at other leading stroke centers across Japan,” said Dr. Houkin. “The need for safe, effective and clinically-practical treatments for ischemic stroke patients has never been greater. Based on the clinical results from the recently completed MASTERS-1 Phase II clinical study, many believe that innovative treatments like MultiStem cell therapy hold great promise for treating the devastating effects of a stroke and helping patients recover more effectively. Given the rapidly expanding aging population both in Japan and globally, safe and effective treatments that can reach a greater number of stroke victims could make a significant difference for many patients and their families.” In conjunction with the ISC 2017 conference, Athersys also announced an informational video featuring former NFL player and stroke survivor Tedy Bruschi. Available for viewing at https://www.youtube.com/user/AllianceRegenMed, the video focuses on the potential of increasing the post-ischemic stroke treatment window while chronicling the challenges facing doctors with today’s limited options. CBS broadcaster Solomon Wilcots moderates the video that includes stories of both Bruschi and a Houston stroke survivor who participated in the MASTERS-1 study. The International Stroke Conference is the world’s premier meeting dedicated to the science and treatment of cerebrovascular disease. Clinical Sessions focus on community risk factors; emergency care; acute neuroimaging; acute endovascular and acute nonendovascular treatment; diagnosis of stroke etiology; cerebral large artery disease; in-hospital treatment; clinical rehabilitation and recovery; and health services, quality improvement, and patient-centered outcomes. Basic Science Sessions focus on vascular biology in health and disease; basic and preclinical neuroscience of stroke recovery; and experimental mechanisms and models. Further specialized topics include pediatric stroke; intracerebral hemorrhage; nursing; preventive strategies; vascular cognitive impairment; aneurysms; subarachnoid hemorrhage; neurocritical care; vascular malformations; and ongoing clinical trials. Presentations on these topics attract a wide range of healthcare professionals and investigators including adult and pediatric neurologists; neurosurgeons; neuroradiologists and interventional radiologists; physiatrists; emergency medicine specialists; primary care physicians; hospitalists; nurses and nurse practitioners; rehabilitation specialists; physical, occupational, and speech therapists; pharmacists; and basic researchers spanning the fields of cerebrovascular function and disease. MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors produced in response to signals of inflammation and tissue damage.  MultiStem therapy’s potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The product represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent safety profile demonstrated in both preclinical and clinical settings, MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need. Athersys has forged strategic partnerships and a broad network of collaborations to develop MultiStem cell therapy for a variety of indications, with an initial focus in the neurological, cardiovascular and inflammatory and immune disorder areas. Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, cardiovascular, inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions to further develop its platform and products. More information is available at www.athersys.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," “suggest,” "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of ischemic stroke, acute myocardial infarction, spinal cord injury and acute respiratory distress syndrome and other disease indications, including graft-versus-host disease. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the success of our collaboration with Healios and others, including our ability to reach milestones and receive milestone payments, and whether any products are successfully developed and sold so that we earn royalty payments; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements; the success of our efforts to enter into new strategic partnerships or collaborations and advance our programs; our ability to raise additional capital; results from our MultiStem ongoing and planned clinical trials, including the MASTERS-2 Phase 3 clinical trial and the Healios TREASURE clinical trial in Japan; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials within the expected time frame or at all; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.


Patent
Athersys and Oregon Health And Science University | Date: 2014-01-15

Isolated cells are described that are not embryonic stem cells, not embryonic germ cells, and not germ cells. The cells can differentiate into at least one cell type of each of at least two of the endodermal, ectodermal, and mesodermal lineages. The cells do not provoke a harmful immune response. The cells can modulate immune responses. As an example, the cells can suppress an immune response in a host engendered by allogeneic cells, tissues, and organs. Methods are described for using the cells, by themselves or adjunctively, to treat subjects. For instance, the cells can be used adjunctively for immunosuppression in transplant therapy. Methods for obtaining the cells and compositions for using them also are described.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 224.72K | Year: 2014

DESCRIPTION (provided by applicant): This is a resubmission of a Phase I-Phase II Fast-Track application for the clinical use of MultiStem in patients with acute respiratory distress syndrome (ARDS). ARDS is defined as acute onset hypoxemia, bilateral radiographic pulmonary infiltrates and lack of atrial pressure hypertension. A novel and exiting possibility is the use of cells as part of the therapy in lung injury. We and other groups have demonstrated that exogenous infusion of isolated mesenchymal stem cells (B-MSC) prevents inflammation and aberrant repair after lung injury. These and other observations suggest that B-MSC is a potentially safe and effective therapeutic intervention in lung injury. Progress toward B-MSC as a cell therapy for ARDS in humans requires completion of preclinical studies and validation in animal models. We propose to evaluate the therapeutic effect of a GMP-produced human adherent bone marrow derived stem cell (MultiStem) in a sheep model of endotoxin-induced moderate-sever


Grant
Agency: GTR | Branch: Innovate UK | Program: | Phase: Collaborative Research & Development | Award Amount: 2.00M | Year: 2015

MUST-ARDS (MultiStem® for the Treatment of Acute Respiratory Distress Syndrome) is a phase 1/2 clinical trial designed to investigate a novel adult cell therapy for ARDS. MultiStem is an allogeneic, adult, multipotent progenitor stem cell that is currently being investigated in phase 2 clinical trials to treat ischemic stroke and ulcerative colitis. Athersys, Ltd., a SME and clinical stage biotechnology company, has been developing the MultiStem cell therapy platform for multiple disease indications. MultiStem cells exhibit a drug-like profile in that they act primarily through the production of multiple factors that regulate the immune system, protect damaged or injured tissue, promote tissue repair and healing and enhance the formation of new blood vessels in regions of ischemic injury. Athersys and the Cell Therapy Catapult through MUST-ARDS determine if MultiStem can reduce mortality, shorten hospital stay and improve patient outcomes for those suffering from ARDS.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.71M | Year: 2015

DESCRIPTION provided by applicant Cardiovascular disease CVD represents a significant unmet medical need with over million patients in the United States suffering from acute myocardial infarction AMI each year This epidemic of heart attacks also represents a risk factor for further cardiovascular disease with over million individuals suffering from chronic heart failure CHF and andgt new patients diagnosed with CHF annually in the United States CHF is associated with high morbidity and mortality as well as high cost of care In fact taken together CVD is the leading cause of death in the United States and is responsible for an estimated $ billion dollars annually in direct and indirect costs according the American Heart As the population ages and the incidence of diabetes and obesity increase the incidence and associated cost of care for CVD Is expected to rise as well By the number of people in US age and over will increase by Despite the high cost of care and prevalence the medical options to treat both AMI and CHF are limited Based on the current clinical data it would appear highly likely that cell therapy will play a role in the prevention ad treatment of cardiac dysfunction in the ensuing years In this study we proposed to develop in the Phase I portion of this proposal an adult bone marrow derived cell therapy product MultiStem that can formulated in a cryovial for rapid thaw and delivery to treat acute ischemic injury For the Phase II portion we plan to investigate the effects of cell therapy in a specific nd novel population of patients with cardiovascular disease those patients with heart attacks that present as non ST elevated myocardial infarcts NSTEMI to determine if we can reduce the morbidity and mortality and provide functional benefit to the heart Importantly the NSTEMI population is growing in prevalence unlike the clinical population of first time ST elevation AMI which has been steadily declining over the past decade Successful completion of these studies will provide the data required for a Phase III registration trial that will be required to market MultiStem for the treatment of acute cardiovascular injury PUBLIC HEALTH RELEVANCE The development of cell therapy for the treatment of acute cardiovascular injury will provide a novel therapeutic for one the leading causes of death in the world


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase II | Award Amount: 450.04K | Year: 2016

DESCRIPTION provided by applicant This is a resubmission of a Phase I Phase II Fast Track application for the clinical use of MultiStem in patients with acute respiratory distress syndrome ARDS ARDS is defined as acute onset hypoxemia bilateral radiographic pulmonary infiltrates and lack of atrial pressure hypertension A novel and exiting possibility is the use of cells as part of the therapy in lung injury We and other groups have demonstrated that exogenous infusion of isolated mesenchymal stem cells B MSC prevents inflammation and aberrant repair after lung injury These and other observations suggest that B MSC is a potentially safe and effective therapeutic intervention in lung injury Progress toward B MSC as a cell therapy for ARDS in humans requires completion of preclinical studies and validation in animal models We propose to evaluate the therapeutic effect of a GMP produced human adherent bone marrow derived stem cell MultiStem in a sheep model of endotoxin induced moderate severe ARDS To our knowledge there are no published references on the use of this animal model to evaluate the effect of cell therapies for ARDS making these pre clinical studies unique and highly novel This proposal is the result of a close collaboration between the McGowan Institute of Regenerative Medicine the Division of Pulmonary Allergy and Critical Care and the Division of Cardiothoracic Transplantation at the University of Pittsburgh with Athersys Inc a biotechnology company specialized in the generation of an allogeneic GMP grade bone marrow derived adherent stem cells termed MultiStem We propose that a partnership between academia and industry will accelerate and validate the use of human GMP produced MultiStem in patients with ARDS Our groups have the infrastructure and expertise required to assure successful completion of this project Our goal is to complete the necessary pre clinical studies required to obtain an Investigational New Drug IND Based on a pre IND meeting with the FDA their suggestions have been incorporated in the present proposal {Determination of the biological consequences of intrabronchial or intravenous delivery of MultiStem on the sheep model of LPS induced ARDS} and Specific Aim Phase II to demonstrate the safety of MultiStem in patients with ARDS in a Phase I clinical trial PUBLIC HEALTH RELEVANCE Acute Respiratory Distress Syndrome ARDS is a very common clinical entity and a major cause of morbidity and mortality in the critical care setting with limited therapeutic options The development of cell therapy for the treatment of ARDS will provide a novel therapeutic for this significant disease


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 300.00K | Year: 2012

DESCRIPTION (provided by applicant): Previously performed and published studies have demonstrated that MultiStem(R), Athersys' patented adult adherent stem cell product, modulates the inflammatory component of secondary brain injury in rodent models of traumatic brain injury (TBI). Further, there are supporting published data illustrating the efficacy of MultiStem in other CNS injury models including stroke, hypoxic-ischemic injury, and spinal cord injury among others. Athersys, Inc., and the University ofTexas Medical School at Houston have a collaborative research agreement in place for the development of proof-of-concept studies in vivo and in vitro for the treatment of TBI and stroke. The ultimate goal of this relationship is to translate these initialpositive findings into clinical trials and novel therapeutic approaches for neurological injury. The specific objective of this SBIR Fast-Track Research Proposal is to define and successfully execute pivotal pre-clinical safety and efficacy studies required for a successful Investigational New Drug submission to the FDA for an optimized cellular therapy regimen for treatment of TBI and its related outcomes. This application proposes an initial GLP toxicity study in Phase 1, followed by sequential studies to address clinically relevant translational issues in progenitor cell therapy for neurological injury/disease. The specific aims are: Phase 1: Define the safety profile of MultiStem delivered intravenously after TBI with both short and long-term GLP toxicity/pathology-necropsy evaluation. The rationale for the proposed groups is that safety must be defined in naive and injured animals, since injury affects biodistribution secondary to chemo-attractant signals from injured tissues. NO GO decision will be based principally on the development of ectopic tissue in any organ (not just cell presence), or significant exacerbation of inflammation/organ function. Phase 2a: The goal of Phase 2a is the completion of comprehensive toxicity studies in TBI, with doses shown to be efficacious in our previous proof-of-concept efficacy testing in rodents. Comprehensive toxicity and anatomic pathology studies will need to be completed at higher doses/multiple doses based on previous proof- of-concept studies. GO/NO GO decisions will be made by assessing the dose toxicity profiles (compared to Controls) relative to previous proof-of-concept efficacy data. Phase 2b: The goal of the Phase 2b portion of the proposal is to establish the optimal dosing scheme based on primary and secondary outcomes measures, after clearing safety studies in Phase 1 and Phase 2a. Translational issues of catheter delivery systems and osmolarity of the cell infusion environment will be evaluated in terms of affecting cell survival and potency. Phase 2c:The primary goals of this sub-phase are (1) IND submission for both adult and pediatric protocols using intravenous MultiStem for severe TBI, and (2) addressing/revising the submissions in response to any critiques, and (3) approval and local IRB submission to allow initiation of the clinical trials.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 212.80K | Year: 2015

DESCRIPTION provided by applicant One out of every fifty people living in the United States suffers from some form of paralysis a total of almost million Americans This proposal outlines the translational development of a cellular therapeutic already in clinical trials with a novel regenerative peptide to be used in combination for treatment of spinal cord injury SCI and associated dysfunction Preclinical data from Athersys has demonstrated that acute intravenous administration of bone marrow derived multipotent adult progenitor cells MAPC provides immediate and durable neuroprotection after SCI Benefit to locomotor recovery was seen beginning at one week post injury as well as significant sparing of white matter tracts Dr Silver and his colleagues have identified the glial scar as a significant impediment to long distance regeneration specifically inhibitory molecules known as chondroitin sulfate proteoglycans CSPGs After discovering the receptor and signaling pathways associated with this pathway Dr Silverandapos s laboratory has developed a novel peptide Intracellular Sigma Peptide ISP which modulates the key receptor in this pathway In a preclinical study long term subcutaneous treatment with this peptide initiated in the acute phase following spinal cord injury allowed for delayed recovery of locomotion and bladder behaviors following SCI Interestingly while ISP treatment resulted in recovery it had no neuroprotective effects In the month time frame of this Phase I project we propose to combine the use of MAPC with ISP treatment following a translationally relevant rodent model of contusive SCI with the therapeutic aims of i promoting enhanced neuroprotection and ii enhancing sprouting regeneration by altering the response of regenerating axons to inhibitory extracellular matrix We will evaluate the synergistic effects of treatment by analyzing improvements in motor hind limb recovery return of coordinated control of the lower urinary tract and quantification of neuronal sprouting regeneration Dr Silver and collaborators have been investigating the ability of ISP peptide to induce sympathetic neural regeneration and alleviate arrhythmia following myocardial ischemia reperfusion injury This data suggests that ISP could also be utilized in other disorders in which CSPGs play a critical inhibitory role such as traumatic brain injury multiple sclerosis and stroke The fact that MAPC has already proven efficacious in preclinical models of acute myocardial infarction multiple sclerosis traumatic brain injury and stroke dramatically expands the impact that this combinatorial therapy could have in the field of regenerative medicine If MAPC and ISP administration can be shown to be effective in ameliorating SCI associated deficits and dysfunction this therapy could relieve some of the economic burden on the direct and indirect costs associated with SCI related care and more importantly provide meaningful improvement to SCI patients Both treatments are non invasive and systemic making them highly attractive therapeutic options for clinical use PUBLIC HEALTH RELEVANCE This proposal outlines the translational development of a cellular therapeutic already in clinical trials with a novel regenerative peptide to be used in synergy for treatment of contusive spinal cord injury SCI and associated dysfunction We propose to test the combined use of two non invasive and systemic therapeutics in a rodent model with the therapeutic aims of i promoting enhanced neuroprotection and ii enhancing regeneration If successful this combinatorial therapy could relieve a significant portion of the economic burden on the direct and indirect costs associated with SCI related care and more importantly provide meaningful improvement to SCI patients


The present invention generally relates to a series of compounds, to pharmaceutical compositions containing the compounds, and to use of the compounds and compositions as therapeutic agents. More specifically, compounds of the present invention are tricyclic indeno-pyrrole compounds. These compounds are serotonin receptor (5-HT) ligands and are useful for treating diseases, disorders, and conditions wherein modulation of the activity of serotonin receptors (5-HT) is desired (e.g. anxiety, depression and obesity).


The invention relates to the treatment of various injuries, disorders, dysfunctions, diseases, and the like with MAPCs, without the need for adjunctive immunosuppressive treatment.

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