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News Article | May 17, 2017
Site: www.eurekalert.org

CLEVELAND - Results from the DAWN stroke trial presented at the European Stroke Organization Conference (ESOC) provide compelling evidence that selected patients suffering a major ischemic stroke recovered significantly better with mechanical retrieval of the blood clot with medical therapy compared with medical therapy alone when initiated past the current guidelines of within 6 hours and up to 24 hours of the stroke. University Hospitals Cleveland Medical Center was one of the top seven recruiting sites in the multi-site study that enrolled a total of 206 patients in the nation. The results showed that patients treated with the retrieval system, known as mechanical thrombectomy, had significantly decreased post-stroke disability and improved functional independence at 90 days compared to medical management alone. "This is incredible," said Cathy Sila, MD, Director of UH's Comprehensive Stroke Center, and principal investigator of the study at the UH site. "Almost half of the patients (48.6 percent) receiving the thrombectomy therapy had a good outcome at 90 days after treatment--defined as the patients being independent in activities of daily living--as opposed to only 13.1 percent of the patients treated medically or with clot-busting drugs alone. This 35 percent difference may be higher than any level of benefit from any stroke trial." "Not only did the patients treated with mechanical thrombectomy dramatically improve during hospitalization, sometimes being able to walk and be discharged to home, but there was also a much lower risk of subsequent neurological worsening because of the poor blood flow to the brain," said Dr. Sila. "The number of patients needed to treat to achieve a good outcome was 2.8. This is a much greater chance of response than what was seen in trials that did not routinely use advanced brain imaging to guide treatment," she said. "We have long believed in the usefulness of MRI scans to define appropriateness of treatment. UH had been using a similar MRI protocol since 2010, five years before the DAWN trial began in 2015." Anthony Furlan, MD, Chairman of the Department of Neurology at UH and Case Western Reserve University School of Medicine, was on the DAWN study's steering committee and helped write the study protocol. "These results provide physicians who treat stroke with evidence of the benefits of thrombectomy even when administered out as far as 24 hours, and should help to make decisions clearer as to which patients to treat," said Dr. Furlan. "These positive outcomes of the DAWN trial represent a major change in patient selection for endovascular therapy for stroke," he said. In the study, researchers used neuroimaging to determine which patients would likely benefit from the procedure. According to Dr. Sila, they would examine how much brain tissue had suffered irreversible damage and how much might be able to be saved. If the amount of damaged tissue were no bigger than the size of a small apricot, researchers believed the patient could benefit from the therapy. Neuro-interventionists would then use a mechanical stent retriever called the Trevo Retriever to remove the blood clot, followed by treatment with the clot-busting medication. The study had been stopped earlier this year after an FDA-approved planned interim review by the independent Data Safety Monitoring Board (DSMB) of data from the first 200 patients enrolled nationally because there was such a dramatic difference between the two arms of the study. The study had been designed to enroll up to a maximum of 500 patients. Dr. Sila said that in Northeast Ohio, we have about 18,000 strokes per year. Stroke survivors commonly experience devastating disabilities and loss of independence due to impaired movement, paralysis, loss of speech and memory. Randomized clinical data has proven the benefit of mechanical thrombectomy with stent retrievers in helping patients with large vessel occlusion strokes, but these devices have only been indicated to reduce disability if used within six hours of stroke onset. "For patients presenting with stroke symptoms beyond six hours, the benefit of clot retrieval using a stent retriever was unknown," said Dr. Furlan. "Now we have evidence that for patients who present to the hospital outside of the six hour time window could have a better chance for an independent life with improved clinical outcomes. Although this is great news, earlier treatment is always better because with stroke 'time is brain.'" The study was supported by Stryker, which produces the Trevo Retriever, a tiny stent-shaped medical device that is attached to a thin wire. The retriever is designed to ensnare the blood clot to remove it from a blood vessel. UH is working with Case Western Reserve University to develop the Cleveland Brain Health Initiative, linking this kind of leading edge neuroscience work from CWRU, UH, Cleveland Clinic, MetroHealth Medical Center and the Louis Stokes Cleveland VA Medical Center to advance progress therapy and treatment of devastating neurological diseases. A video of a UH patient who was in the DAWN trial at: http://www. The DAWN trial is an international, multi-center, blinded endpoint assessment, randomized study. The purpose of the study is to demonstrate superior clinical outcomes at 90 days with Stryker's Trevo Retriever plus medical management compared to medical management alone in appropriately selected patients treated six to 24 hours after last seen well. The Trevo Retriever indication within the DAWN Trial is currently approved for investigational use only by the U.S. Food and Drug Administration in the United States under an Investigational Device Exemption (IDE) study approval. Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 40 outpatient health centers and 200 physician offices in 15 counties throughout northern Ohio. The system's flagship academic medical center, University Hospitals Cleveland Medical Center, located on a 35-acre campus in Cleveland's University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; University Hospitals MacDonald Women's Hospital, Ohio's only hospital for women; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including "America's Best Hospitals" from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals - part of The Harrington Project for Discovery & Development. UH is the second largest employer in northern Ohio with 26,000 employees. For more information, go to UHhospitals.org. The Trevo Retriever is a tiny stent-shaped medical device that is attached to a thin wire. In a minimally invasive procedure that utilizes X-ray, the physician navigates the retriever from the femoral artery (located in the upper leg) to the blocked blood artery in the brain. The retriever is designed to ensnare the blood clot and remove it from the body. Originally cleared by the FDA in 2012 for the revascularization of patients experiencing ischemic stroke, the Trevo Retriever has been used in thousands of patients worldwide. Stryker's Trevo Retriever was the only mechanical thrombectomy device used in this trial. An animation of Stryker's Trevo Retriever is available here: https:/ An ischemic stroke occurs when an artery in the brain becomes blocked by a blood clot or other substance such as plaque, a fatty material. Blood vessels carry blood, oxygen and nutrients throughout the body and to the brain. When the brain is deprived of blood and oxygen, it fails to work properly. Depending on the severity of the stroke and the area of the brain affected, loss of brain function or death may occur. According to the World Heart Federation, ischemic stroke contributes to nearly six million deaths around the globe. Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at http://www.


News Article | May 17, 2017
Site: www.sciencedaily.com

Results from the DAWN stroke trial presented at the European Stroke Organization Conference (ESOC) provide compelling evidence that selected patients suffering a major ischemic stroke recovered significantly better with mechanical retrieval of the blood clot with medical therapy compared with medical therapy alone when initiated up to 24 hours of the stroke. University Hospitals Cleveland Medical Center was one of the top seven recruiting sites in the multi-site study that had a total of 206 patients in the nation. The results showed that patients treated with the retrieval system, known as mechanical thrombectomy, had significantly decreased post-stroke disability and improved functional independence at 90 days compared to medical management alone. "This is incredible," said Cathy Sila, MD, Director of UH's Comprehensive Stroke Center, and principal investigator of the study at the UH site. "Almost half of the patients (48.6 percent) receiving the thrombectomy therapy had a good outcome at 90 days after treatment -- defined as the patients being independent in activities of daily living -- as opposed to only 13.1 percent of the patients treated medically with clot-busting drugs alone. This 35 percent difference may be higher than any level of benefit from any stroke trial." "Not only did the patients treated with the device and the procedure have dramatic improvement during hospitalization, sometimes being able to walk and be discharged to home, there was also a much lower risk of them having subsequent neurological worsening because of the poor blood flow to the brain," said Dr. Sila. "The number of patients needed to treat to achieve a good outcome was 2.8. This is a much greater chance of response than what was seen in trials that did not routinely use advanced brain imaging to guide treatment," she said. "UH had been using this protocol since 2010, five years before the DAWN trial began in 2015." Anthony Furlan, MD, Chairman of the Department of Neurology at UH and Case Western Reserve University School of Medicine, was on the DAWN study's steering committee and helped write the study protocol. "These results provide physicians who treat stroke with evidence of the benefits of thrombectomy even when administered out as far as 24 hours, and should help to make decisions clearer as to which patients to treat," said Dr. Furlan. "These positive outcomes of the DAWN trial represent a major change in patient selection for endovascular therapy for stroke," he said. In the study, researchers used neuroimaging to determine which patients would likely benefit from the procedure. According to Dr. Sila, they would examine how much brain tissue had suffered irreversible damage and how much might be able to be saved. If the amount of damaged tissue were no bigger than the size of a small apricot, researchers believed the patient could benefit from the therapy. Neuro-interventionists would then use a mechanical stent retriever called the Trevo Retriever to remove the blood clot, followed by treatment with the clot-busting medication. The study had been stopped earlier this year after an FDA-approved planned interim review by the independent Data Safety Monitoring Board (DSMB) of data from the first 200 patients enrolled nationally because there was such a dramatic difference between the two arms of the study. The study had been designed to enroll up to a maximum of 500 patients. Dr. Sila said that in Northeast Ohio, we have about 18,000 strokes per year. Stroke survivors commonly experience devastating disabilities and loss of independence due to impaired movement, paralysis, loss of speech and memory. Randomized clinical data has proven the benefit of mechanical thrombectomy with stent retrievers in helping patients with large vessel occlusion strokes, but these devices have only been indicated to reduce disability if used within six hours of stroke onset. "For patients presenting with stroke symptoms beyond six hours, the benefit of clot retrieval using a stent retriever was unknown," said Dr. Furlan. "Now we have evidence that for patients who present to the hospital outside of the six hour time window could have a better chance for an independent life with improved clinical outcomes. Although this is great news, earlier treatment is always better because with stroke 'time is brain.'" The study was supported by Stryker, which produces the Trevo Retriever, a tiny stent-shaped medical device that is attached to a thin wire. The retriever is designed to ensnare the blood clot to remove it from a blood vessel. UH is working with Case Western Reserve University to develop the Cleveland Brain Health Initiative, linking this kind of leading edge neuroscience work from CWRU, UH, Cleveland Clinic, MetroHealth Medical Center and the Louis Stokes Cleveland VA Medical Center to advance progress therapy and treatment of devastating neurological diseases. A video of a UH patient who was in the DAWN trial at: http://www.uhhospitals.org/services/neurology-and-neurosurgery/institute/our-centers/comprehensive-stroke-center/patient-stories/bessies-story


News Article | May 15, 2017
Site: www.eurekalert.org

Lung cancer tumors were prevented in mice by a novel small molecule that directly activates a tumor suppressor protein. Goutham Narla, MD, PhD, Pardee-Gerstacker Professor in Cancer Research, Associate Professor at Case Western Reserve University School of Medicine and member of the Case Comprehensive Cancer Center in Cleveland, Ohio. Cells are constantly turning proteins on and off via molecular switches--phosphate molecules--that have become common drug targets. Said Dr. Narla, "All the drugs we currently have to treat our cancer patients target what we call kinases, which attach phosphate molecules to proteins. But equally important to this are the enzymes that take the phosphate off." One enzyme--PP2A--can "turn off" tumor proteins by removing phosphate molecules attached to them. But according to Dr. Narla, "This tumor suppressor is turned off in pretty much every major cancer. Its inactivation is essential for a normal cell to become a cancer cell." Narla and his team decided to take an unconventional approach to cancer drug development by seeking molecules that directly target PP2A, in an effort to reactivate its tumor suppressor properties. Forty-five researchers, including eight students from the Young Scientist Foundation and Mark R. Chance, PhD, Vice Dean for Research at Case Western Reserve School of Medicine, collaborated to screen a series of drug-like molecules for their ability to reactivate PP2A in lung cancer cells and prevent lung cancer tumors in mice. The prototype drug molecules were created from FDA-approved medications by Michael Ohlmeyer, PhD, Associate Professor at Icahn School of Medicine at Mount Sinai. The team found one particular prototype drug can attach to a subunit of the PP2A protein, effectively activating the enzyme. As Narla explained, the study is the first to use a small molecule to directly activate an enzyme that removes phosphate molecules. "There are indirect ways that have been shown to get at these kinds of enzymes, but this is the first example of a direct activation of one. Our drug actually binds to and turns on PP2A." The prototype drug also prevented lung cancer cells from proliferating in laboratory models, including mouse models. Mice injected with the drug had fewer lung cancer tumors and did not experience weight loss or behavioral abnormalities associated with other cancer medications. In the mouse models, the drug was comparably effective to currently available combination therapies used to slow lung cancer progression. To confirm exactly where the drug attaches to PP2A, the researchers also developed lung cancer cells with specific mutations at the putative drug binding site. Mice with tumors created from the mutated cancer cells did not benefit from the prototype drug, as the drug could not attach to and reactivate PP2A. The results confirmed that the prototype drug attaches to PP2A at two specific amino acids within a subunit of the enzyme, information that could help inform other drug developers. "This is the first example ever of a cancer drug that directly binds to and activates an enzyme that removes phosphate molecules. Therefore our findings could have broad applicability to the treatment of a large number of human cancers, including lung cancer as we demonstrated in this paper," Narla said. "There are some 2,000 plus papers on the role of PP2A in cancer. Breast cancer, prostate cancer, lung cancer, brain cancer, childhood cancers, ovarian cancer, endometrial cancer, every major cancer involves the inactivation of this protein," Narla noted. "Molecules that allow us to turn it back on, like the one in our study, have the potential to work in a broad range of cancer patients." "We are continuing to test our drug in a large series of animal models. If things continue to go well, we hope to start clinical trials next year with this drug. Our initial clinical trials would be quite broad, and would include a number of diverse cancer patients, including patients with lung cancer." Narla said. "The Young Scientists supported by the Young Scientist Foundation, http://www. , were integral to these discoveries," Narla added. "I think their contributions highlight, in an increasingly competitive funding environment, the importance of STEM and the benefit of engaging youth early on in biomedical research." The study included pre-clinical cell and animal models that may not necessarily translate to human lung cancer. Mice were implanted with lung cancer tumors, rather than developing them on their own, and treated with the drug for only four weeks. Long-term effects of the prototype drug remain unknown. The study was funded by the National Institutes of Health (NIH), Howard Hughes Medical Institute (HHMI), Case Western Reserve University (CWRU), University Hospitals through the Harrington Discovery Institute, and Dual Therapeutics. The Icahn School of Medicine at Mount Sinai on behalf of the authors GN, MO, NSD, DBK have filed patents covering composition of matter on the small molecules used in the study for the treatment of human cancer and other diseases. Dual Therapeutics LLC has licensed this intellectual property for the clinical and commercial development of this series of small molecule PP2A activators. The authors GN, MO, YI, NSD, DBK have an ownership interest in Dual Therapeutics LLC. GN and MO are consultants for Dual Therapeutics LLC. For more information about Case Western Reserve University School of Medicine, please visit: http://case. .


News Article | April 19, 2017
Site: www.eurekalert.org

In the United States, almost three of every 1,000 children are born with a detectable level of hearing loss in one or both ears. An early-stage researcher at Case Western Reserve University School of Medicine is receiving a major grant to help address the problem in an innovative way. Martin Basch, PhD, assistant professor of otolaryngology - head and neck surgery, has been named a recipient of a 2016 Hartwell Individual Biomedical Research Award. The award helps researchers pursue early-stage, cutting-edge biomedical pediatric research. With the award, Basch will pioneer the study of cell therapies to treat congenital strial deafness, with the goal of restoring hearing. The 2016 award, which provides $300,000 in direct costs for three years, is being given to 12 recipients from 10 institutions nationally. The Hartwell Foundation is a Memphis-based philanthropic institution that funds innovative biomedical research to benefit children of the United States. "I want to express my gratitude to The Hartwell Foundation for recognizing the important work of Dr. Basch and providing generous support for his future critical discoveries," said Lynn Singer, PhD, deputy provost and vice president for academic affairs at Case Western Reserve University. "The Foundation's commitment to supporting the next generation of pediatric researchers is paving the way for better health outcomes for children everywhere." "The Hartwell Foundation seeks to inspire innovation and achievement by offering individual researchers an opportunity to realize their professional goals. We provide an opportunity for those we support to make a difference and to realize their hopes and dreams," said Fred Dombrose, PhD, president of The Hartwell Foundation. With the grant, Basch will focus on developing a therapeutic approach for restoring hearing using a model of congenital strial deafness. Normal hearing requires the proper development of the cochlea, the hearing portion of the inner ear. The cochlea includes the auditory organ that contains the sensory hair cells responsible for sound detection and the stria vascularis, the "battery" that provides the energy for auditory hair cells to function. "Although 30 to 40 percent of congenital hearing loss is accounted for by defects in the stria, the regenerative potential of this complex tissue has been largely unexplored," Basch said. "Over the past decade, considerable and important efforts have been made to understand the biology of the sensory hair cells in the mammalian cochlea, with the aim of applying the principles of embryonic development to regenerative therapies. I will be adding a new focus on the stria vascularis to this vital work." Basch's hypothesis is that specialized cells isolated from the stria vascularis which have not fully differentiated and still preserve many characteristics from their progenitor cells retain the ability to differentiate into functional mature intermediate cells. He will research if such stem cells will restore hearing when injected into the lateral wall of the cochlea in a strial deafness mouse model. "If we are successful," Basch said, "it should be possible to generate equivalent human cell lines and conduct clinical trials, with the potential to benefit the large number of children affected with severe hearing loss due to defects in the stria." In addition to the Individual Biomedical Research Award, Case Western Reserve qualified for a Hartwell Fellowship of $100,000 to support a postdoctoral candidate for two years. CWRU will select its recipient later this spring. Case Western Reserve has seven other faculty members who are current or former Hartwell investigators: Basch, a native of Buenos Aires, Argentina, earned his doctorate in 2004 at the California Institute of Technology and joined the Department of Otolaryngology at CWRU School of Medicine in May 2015. For more information about Case Western Reserve University School of Medicine, please visit: http://case. .


News Article | November 17, 2016
Site: globenewswire.com

XBiotech's True Human antibodies Targeting IL-1 alpha (IL-1alpha) to be used in Researching Treatment for Inflammatory Bowel Disease (IBD) AUSTIN, Texas, Nov. 17, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), developer of True Human(TM) therapeutic antibodies, announced today commencement of a collaboration with a research team at Case Western Reserve University (CWRU) School of Medicine headed by leading gastroenterologist, Fabio Cominelli, M.D., Ph.D. Dr. Cominelli and his research team will conduct pre-clinical studies to help develop new treatments for Inflammatory Bowel Disease (IBD) using the company's pioneering approach to using natural human antibody therapy to neutralize harmful inflammation. Dr. Cominelli is a world-leading expert in inflammatory bowel disease. His group was the first to report that specific blockade of interleukin-1 (IL-1) was effective in reducing disease severity in colitis and that deregulated inflammation is a cause of auto-inflammatory diseases, including IBD. Dr. Cominelli is Chief of the Division of Gastroenterology and Liver Disease and Director of the Digestive Health Institute at CWRU School of Medicine in Cleveland and Chief Scientific Officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center. Dr. Cominelli is also the Hermann Menges Jr. Chair in Internal Medicine and Professor at CWRU School of Medicine. Dr. Cominelli has a professional interest in Crohn's disease, gastrointestinal (GI) cancer, IBD and ulcerative colitis. He is a member of the American Society for Clinical Investigation and Association of American Physicians. He has previously earned a NIH Merit Award. His work has been published in a number of peer-reviewed journals, such as Inflammatory Bowel Diseases and The Journal of Immunology. Dr. Cominelli earned his medical degree at Universita' Degli Studi di Firenze in Florence, Italy, where he also completed his internal medicine residency. He completed his gastroenterology fellowship at Harbor-UCLA Medical Center in Torrance, California. Dr. Cominelli stated, "I have researched IL-1's role in disease severity in colitis for many years, and am excited about the opportunity to be able to selectively inhibit IL-1 alpha to better define its role in IBD. These results will help shape the design of future clinical trials as we look for new and better treatments for this wide-spread condition." John Simard, the Company's President and Chief Executive Officer, commented, "Dr. Cominelli's past research has formed the foundation for clinical trials with important implications for new treatments for patients suffering from inflammatory diseases of the bowl. We are hopeful that this collaboration will provide for further advances in treatment." About Inflammatory Bowel Disease Inflammatory bowel disease (IBD) is a common condition involving chronic inflammation of the digestive tract. IBD primarily includes ulcerative colitis and Crohn's disease, both of which are typically associated with severe diarrhea, pain, fatigue and weight loss. IBD can have a devastating impact on quality of life and in some cases lead to life-threatening complications. There are approximately 1.6 million Americans and 5 million people worldwide suffering from IBD with as many as 70,000 new cases diagnosed yearly in the U.S1. About True Human(TM) Therapeutic Antibodies Unlike previous generations of antibody therapies, XBiotech's True Human(TM) antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech's True Human antibodies have the potential to harness the body's natural immunity to fight disease with increased safety, efficacy and tolerability. About XBiotech XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human(TM) proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


News Article | November 17, 2016
Site: globenewswire.com

AUSTIN, Texas, Nov. 17, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today commencement of a collaboration with a research team at Case Western Reserve University (CWRU) School of Medicine headed by leading gastroenterologist, Fabio Cominelli, M.D., Ph.D. Dr. Cominelli and his research team will conduct pre-clinical studies to help develop new treatments for Inflammatory Bowel Disease (IBD) using the company’s pioneering approach to using natural human antibody therapy to neutralize harmful inflammation. Dr. Cominelli is a world-leading expert in inflammatory bowel disease. His group was the first to report that specific blockade of interleukin-1 (IL-1) was effective in reducing disease severity in colitis and that deregulated inflammation is a cause of auto-inflammatory diseases, including IBD. Dr. Cominelli is Chief of the Division of Gastroenterology and Liver Disease and Director of the Digestive Health Institute at CWRU School of Medicine in Cleveland and Chief Scientific Officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center. Dr. Cominelli is also the Hermann Menges Jr. Chair in Internal Medicine and Professor at CWRU School of Medicine. Dr. Cominelli has a professional interest in Crohn's disease, gastrointestinal (GI) cancer, IBD and ulcerative colitis. He is a member of the American Society for Clinical Investigation and Association of American Physicians. He has previously earned a NIH Merit Award. His work has been published in a number of peer-reviewed journals, such as Inflammatory Bowel Diseases and The Journal of Immunology. Dr. Cominelli earned his medical degree at Universita’ Degli Studi di Firenze in Florence, Italy, where he also completed his internal medicine residency. He completed his gastroenterology fellowship at Harbor-UCLA Medical Center in Torrance, California. Dr. Cominelli stated, “I have researched IL-1’s role in disease severity in colitis for many years, and am excited about the opportunity to be able to selectively inhibit IL-1 alpha to better define its role in IBD. These results will help shape the design of future clinical trials as we look for new and better treatments for this wide-spread condition.” John Simard, the Company’s President and Chief Executive Officer, commented, “Dr. Cominelli’s past research has formed the foundation for clinical trials with important implications for new treatments for patients suffering from inflammatory diseases of the bowl. We are hopeful that this collaboration will provide for further advances in treatment.” About Inflammatory Bowel Disease Inflammatory bowel disease (IBD) is a common condition involving chronic inflammation of the digestive tract. IBD primarily includes ulcerative colitis and Crohn's disease, both of which are typically associated with severe diarrhea, pain, fatigue and weight loss. IBD can have a devastating impact on quality of life and in some cases lead to life-threatening complications. There are approximately 1.6 million Americans and 5 million people worldwide suffering from IBD with as many as 70,000 new cases diagnosed yearly in the U.S1. About True Human™ Therapeutic Antibodies Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability. About XBiotech XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


News Article | March 2, 2017
Site: www.eurekalert.org

Since the discovery of penicillin in 1928, antibiotics have made the world a much safer and healthier place. But Shakespeare was onto something when he asked if it's possible to have too much of a good thing. In the case of antibiotics, the answer is increasingly "yes." As a result, Case Western Reserve University School of Medicine and Louis Stokes Cleveland VA Medical Center are teaming up to take on the rising problem of antibiotic resistance. A new entity, Case VA CARES, will combine firepower from both organizations in the battle against antibiotic resistance. Staff will carry out new research, work to modify existing antibiotics, try and discover new ones, and use decoys to trick uncooperative bacteria. More and more, bacteria and other microorganisms are developing resistance to antibiotics which used to kill them off. This resistance, which evolves via natural selection through random mutation, is usually caused by excessive use of antibiotics, including in livestock animals raised as human food. In turn, infections which used to yield to antibiotics can persist and even worsen, putting patients in danger. Not only does antibiotic resistance imperil health, it also adds to healthcare costs as doctors try different medicines to find ones bacteria haven't become resistant to. Sometimes the stronger substitute antibiotics cause serious side effects such as kidney damage. More than two million people develop antibiotic-resistant infections in the U.S. ever year, leading to more than 23,000 deaths. Some experts say that without new inroads, the death toll could top that from cancer by mid-century. The financial costs are already enormous: as much as $20 billion in extra healthcare costs annually. Case VA CARES (CWRU-Cleveland VAMC Center for Antimicrobial Resistance and Epidemiology) will be located in the CWRU School of Medicine and Cleveland VA with collaborating partner laboratories located around the world. "An immediate goal of this initiative is to boost research into multidrug-resistant Gram negative organisms such as Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae and mycobacteria, which can cause tuberculosis and many other infections," said Pamela B. Davis, MD, PhD, dean of CWRU School of Medicine. "Understanding the mechanistic and molecular bases of resistance is crucial to properly treating patients with serious infections." In addition to research and drug discovery, experts at the center will work with scientists throughout the world to track outbreaks of resistant organisms, discover new drugs, and develop training for physicians, medical students, and residents to recognize and prevent overuse of antibiotics. The director of the center will be Robert A. Bonomo, MD, medicine service chief at the Louis Stokes Cleveland VA Medical Center. Faculty members of the new center will come from throughout both organizations including experts in infectious diseases, microbiology, molecular biology, biochemistry, pharmacology, proteomics, and bioinformatics. Experienced scientists with expertise in bacterial genome sequencing and bioinformatics analyses will be recruited to augment experts from the CWRU Department of Genetics. "In the search for new antibiotics and fresh strategies for existing ones, Case VA CARES will play a prominent role in leading and conducting research needed to design and conduct clinical trials, which will take place at the VA , University Hospitals, MetroHealth, and the Cleveland Clinic Foundation," said Dr. Bonomo, who is a member of the NIH-funded Antimicrobial Resistance Leadership Group (ARLG). The latter group is addressing national priorities for clinical research on antibiotic resistance. Case VA CARES will also benefit from strong working relationships with industry partners of both the School of Medicine, University Hospitals of Cleveland, MetroHealth, the Cleveland Clinic and the VA Medical Center. Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation's top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School's innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing healthcare environment of the 21st century. Nine Nobel Laureates have been affiliated with the School of Medicine. Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News & World Report's "Guide to Graduate Education." The School of Medicine is affiliated with University Hospitals Cleveland Medical Center, MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002. For more information, visit http://case. . The Louis Stokes Cleveland VA Medical Center is the hub of the Northeast Ohio VA Healthcare System, providing and coordinating primary, acute and specialty care for Veterans. Focusing on treating the whole Veteran through health promotion and disease prevention, the Northeast Ohio VA Healthcare System delivers comprehensive, seamless healthcare and social services for Veterans at 18 locations across Northeast Ohio. The Northeast Ohio VA Healthcare System contributes to the future of medicine through education, training and research programs. For more information visit http://www. .


News Article | November 21, 2016
Site: www.eurekalert.org

A Case Western Reserve University School of Medicine researcher has found that addiction treatment results improved when teens in a residential program stopped smoking. The findings are published in a new study in the November issue of the Journal of Substance Abuse Treatment. They hold important implications for success in treating addiction since up to three out of four people with such disorders are smokers, a significantly higher proportion than the overall national smoking rate of one out of every four Americans. The study found that teens who stopped smoking benefited from lower cravings for alcohol and drugs, and did as well as their peers who smoked in terms of treatment duration, 12-step participation, and global functioning (a numeric scale used by mental health professionals to rate how well clients respond to various psychological and social situations and difficulties). In contrast, young people in the study who smoked were discharged with significantly higher cravings for alcohol and drugs, which has been shown to increase the risk of relapse. Primarily because of smoking prohibitions on-site, 50 percent of participants in the study did not smoke during treatment. (Some requested and received nicotine patches, but the number was too few to evaluate the effects of this smoking-cessation aid). Those who smoked did so when on pass or attending local 12-step meetings outside of the treatment facility. "Our results suggest that quitting smoking is associated with lowered drug and alcohol cravings," said the study's lead author, Maria E. Pagano PhD, associate professor in the department of psychiatry at Case Western Reserve University School of Medicine. "Clearly, this is a positive finding for treating drug and alcohol addiction. However, smoking cessation activities are not typically included in drug and alcohol programs because of worries about overload. The concern is that drug and alcohol addiction is a challenging enough battle by itself, let alone trying to quit smoking at the same time. Our results suggest that this outlook may need to be modified." The findings, collected over a two-year period, are based on assessments of 195 young people, aged 14 to 18, who were court- and therapist- referred to a two-month residential treatment program for addiction. Each week, clients spent approximately 20 hours in therapeutic activities and attended up to ?ve, 12-step meetings in the local community. Two-thirds (67 percent) entered treatment smoking a half-a-pack of cigarettes a day on average. In addition, the study found that patients with attention deficit hyperactivity disorder (ADHD) did not experience similar success rates. "We found that these teens were less likely to quit smoking," said Pagano. "This could help explain their poorer drug and alcohol treatment outcomes." One reason for better treatment outcomes in clients who stopped smoking may be their higher involvement in service activities at 12-step meetings, such as greeting newcomers at the door, putting away chairs, and helping with coffee. Service activity is associated with reduced risk of relapse and going to jail in the year following treatment. "It may be that ADHD patients need even more action-oriented programmatic activities such as these, which offer a distraction from the symptoms of nicotine withdrawal," said Pagano. "Our study suggests that increasing these types of activities for all clients, and doing so at even higher levels for those with ADHD, may result in better recovery rates from addiction, not to mention the enormous personal health and societal benefits of reducing smoking in teens." Pagano also urged increased availability of nicotine patches: "To ease potential suffering caused by nicotine withdrawal, nicotine patches should be routinely offered to all teen smokers in residential treatment. This may increase the number of youths who quit smoking during treatment and get discharged with lower cravings for alcohol and drugs, ultimately improving treatment outcomes and lowering overall health care costs." In addition to Pagano, other CWRU researchers involved in the study were Christina Delos-Reyes, MD, and Kathleen Svala, MD. This research was supported in part by grants awarded to Pagano from the National Institute on Alcohol Abuse and Alcoholism (K01 AA015137) and The John Templeton Foundation. For more information about Case Western Reserve University School of Medicine, please visit: http://case.


News Article | November 16, 2016
Site: www.eurekalert.org

Developing nations may soon be in a better position to finally conquer malaria, thanks to a team of researchers at Case Western Reserve University School of Medicine Malaria has killed more people than any disease caused by a single organism, including small pox and the plague. Symptoms include high fever, copious sweating, nausea and vomiting, and shaking chills. While the industrialized world has been essentially malaria-free for more than half a century, the mosquito-borne malady continues to harm health and jeopardize lives in nearly one hundred largely tropical and subtropical nations worldwide. One of the biggest barriers to eradication has been the absence of a quick, inexpensive, and accurate test. Now, thanks to a team of Case Western Reserve University researchers, developing nations will soon be in a better position to finally conquer malaria. The secret: a portable, battery-operated device that uses magnets and lasers to quickly and inexpensively detect the presence of the disease in the bloodstream. The invention - the Magneto-Optical Detector (MOD) - earned a Patent for Humanity award last month from the U. S. Commerce Department's United States Patent and Trademark Office and will be recognized in a formal ceremony in Washington DC this month. "With MOD, we wanted to close a big gap in identifying people with malaria," said Brian Grimberg, PhD, assistant professor of international health at the CWRU School of Medicine and co-leader of the development team. "It is hard to diagnose malaria accurately using current technology. The standard microscope test can generate up to 36 percent false positives and 18 percent false negatives. This means that many infected people are untreated and can die. Many others who don't have the disease get anti-malarial drugs unnecessarily, which wastes tight resources and contributes to drug resistance." MOD is significantly more accurate than current point-of-care tests and can diagnose all forms of malaria at even very low concentrations. The cost is about $1 per test and results are reported in around a minute. (The current rapid malaria test takes 20 minutes. Microscopic tests take about an hour when conducted by a trained laboratory technician or pathologist.) Although preventable and treatable, malaria is now actively transmitted within 97 countries, according to the World Health Organization. Half of the world's population, an estimated 3.4 billion people, is at risk. Of these, 1.2 billion are at high risk. According to the latest WHO estimates, there were 214 million reported cases worldwide in 2015 and 438,000 reported deaths. Pregnant women are at special risk and fetal development may be compromised. About one in four child survivors of a severe brain-based form of malaria suffers long-term cognitive impairment. The CWRU MOD team is led by Dr. Grimberg and Robert Brown, PhD, distinguished university professor in physics, with key research and development by senior research scientist Robert Deissler, PhD, mechanical designer/machinist Richard Bihary, visiting scientist William Condit, and undergraduate/technician Jason Jones, a CWRU alumnus. Except for Dr. Grimberg, all are members of the CWRU Department of Physics. When malaria parasites consume red blood cells, they release iron-containing crystals called hemozoin - which possess magnetic properties - into the bloodstream. Magnets in MOD are placed near the blood sample, causing the randomly oriented crystals to align, reducing the amount of laser light that can slide through. The resulting laser change allows MOD to determine if someone is infected as well as establish the level of infection. And it only needs a single drop of blood. "The Department of Physics at CWRU regularly conducts advanced research in fields ranging from dark matter to MRI," said Dr. Brown. "My colleagues on the malaria team and I work extensively in magnetic field research and fluid dynamics of magnetic and partially magnetic particles, making it a natural fit to become involved with this project. It is truly rewarding to be addressing fundamental physics problems and developing applications for improved human health." Dr. Grimberg estimates that MOD can save anti-malaria organizations $1.2 billion annually on direct diagnostic savings, increased workforce productivity, and more efficient allocation of prevention and treatment resources. Also, MOD testing is easily administered outside of laboratory facilities, including in community and remote settings. As a result, care workers can bring accurate testing and diagnosis to towns and villages, instead of requiring patients to travel as many as 30 hours each way to a health clinic. Currently a MOD prototype is in use in rural locations in Peru and Kenya, with scaled-up screenings starting in January in Kenya. Collaboration with CWRU's Office of Research and Technology Management and Hemex Health Dr. Grimberg and his colleagues are collaborating with Portland, Oregon-based Hemex Health, which provided funding and licensed MOD for commercialization and wider use. Next steps include shrinking the current shoe-box sized device further and equipping it to operate on solar power. Some of Dr. Grimberg's earliest funding came from the school's Clinical and Translational Science Collaborative, which contributed almost $50,000 to his efforts. Most recently, the Case Western Reserve University Office of Research and Technology Management helped in securing patent protection and connected the MOD team with Hemex Health, which plans to have the final version in trials in 2017 and released with regulatory approvals in late 2018. "This has been a true collaboration," said Dr. Grimberg. "That includes developing MOD with the Physics Department team, enlisting the invaluable support of the CWRU Office of Research and Technology Management, and taking advantage of the roll-out expertise of Hemex Health." The result is an interlocked team poised to dramatically alter how malaria is detected, paving the way for ultimate worldwide eradication. For more information about Case Western Reserve University School of Medicine, please visit: http://case. .


Home > Press > CWRU researchers make biosensor 1 million times more sensitive: Advance aims at detecting cancers earlier, improving treatment and outcomes Abstract: Physicists and engineers at Case Western Reserve University have developed an optical sensor, based on nanostructured metamaterials, that's 1 million times more sensitive than the current best available--one capable of identifying a single lightweight molecule in a highly dilute solution. Their goal: to provide oncologists a way to detect a single molecule of an enzyme produced by circulating cancer cells. Such detection could allow doctors to diagnose patients with certain cancers far earlier than possible today, monitor treatment and resistance and more. "The prognosis of many cancers depends on the stage of the cancer at diagnosis" said Giuseppe "Pino" Strangi, professor of physics at Case Western Reserve and leader of the research. "Very early, most circulating tumor cells express proteins of a very low molecular weight, less than 500 Daltons," Strangi explained. "These proteins are usually too small and in too low a concentration to detect with current test methods, yielding false negative results. "With this platform, we've detected proteins of 244 Daltons, which should enable doctors to detect cancers earlier--we don't know how much earlier yet," he said. "This biosensing platform may help to unlock the next era of initial cancer detection." The researchers believe the sensing technology will also be useful in diagnosing and monitoring other diseases as well. Their research is published online in the journal Nature Materials. It was a terrific teamwork, Strangi said. He worked with postdoctoral researchers Kandammathee Valiyaveedu Sreekanth and Efe Ilker, PhD students Yunus Alapan and Mohamed ElKabbash, Assistant Professor of Physics Michael Hinczewski, Assistant Professor of Aerospace and Mechanical Engineering Umut Gurkan (co-PI) and Antonio De Luca, who was a visiting research scholar in Strangi's lab during this study and is now an associate professor of physics at the University of Calabria in Italy. The science The nanosensor, which fits in the palm of a hand, acts like a biological sieve, isolating a small protein molecule weighing less than 800 quadrillionths of a nanogram from an extremely dilute solution. To make the device so sensitive, Strangi's team faced two long-standing barriers: Light waves cannot detect objects smaller than their own physical dimensions, which range down to about half a micron. And molecules in dilute solutions float in Brownian motion and are unlikely to land on the sensor's surface. By harnessing nanotechnology tools and by coupling a microfluidic channel with an engineered material called a metamaterial, the scientist overcame the limits. The microfluidic channel restricts the molecules' ability to float around and drives them to the sensing area on the surface of the metamaterial. The metamaterial is made of a total of 16 nanostructured layers of reflective and conductive gold and transparent aluminum oxide, a dielectric, each 10s of atoms thick. Light directed onto and through the layers is concentrated into a very small volume much smaller than the wavelength of light. The top gold layer is perforated with holes, creating a grating that diffuses light shone on the surface into two dimensions. The incoming light, which is several hundreds of nanometers in wavelength, appears to be confined and concentrated in a few nanometers at the interface between the gold and the dielectric layer. As the light strikes the sensing area, it excites free electrons causing them to oscillate and generate a highly confined propagating surface wave, called a surface plasmon polariton. This propagating surface wave will in turn excite a bulk wave propagating across the sensing platform. The presence of the waves cause deep sharp dips in the spectrum of reflecting light. The combination and the interplay of surface plasmon and bulk plasmon waves are what make the sensor so sensitive. Strangi said. By exciting these waves through the eight bilayers of the metamaterial, they create remarkably sharp resonant modes. Extremely sharp and sensitive resonances can be used to detect smaller objects. "It's extremely sensitive," Strangi said. "When a small molecule lands on the surface, it results in a large local modification, causing the light to shift." The potential Depending on the size of the molecule, the reflecting light shifts different amounts. The researchers hope to learn to identify specific molecules, beginning with biomarkers for different cancers, by their light shifts. To add specificity to the sensor, the team added a layer of trap molecules, which are molecules that bind specifically with the molecules they hunt. In tests, the researchers used trap molecules to catch two different biomolecules: bovine serum albumin, with a molecular weight of 66,430 Daltons, and biotin, with a molecular weight of 244 Daltons. Each produced a signature light shift. Other researchers have reported using plasmon-based biosensors to detect biotin in solutions at concentrations ranging from more than 100 micromoles per liter to 10 micromoles per liter. This device proved 1 million times more sensitive, finding and identifying biotin at a concentration of 10 picomoles per liter. Testing and implications In Cleveland, Strangi and Nima Sharifi, MD, co-leader of the Genitourinary Cancer Program for the Case Comprehensive Cancer Center, have begun testing the sensor with proteins related to prostate cancers. "For some cancers, such as colorectal and pancreatic cancer, early detection is essential," said Sharifi, who is also the Kendrick Family Chair for Prostate Cancer Research at Cleveland Clinic. "High sensitivity detection of cancer-specific proteins in blood should enable detection of tumors when they are at an earlier disease stage. "This new sensing technology may help us not only detect cancers, but what subset of cancer, what's driving its growth and spread and what it's sensitive to," he said. "The sensor, for example, may help us determine markers of aggressive prostate cancers, which require treatments, or indolent forms that don't." Strangi's lab is working with other oncologists worldwide to test the device and begin moving the sensor toward clinical use. "We consider this just the beginning of our research," he said. For more information, please click If you have a comment, please us. Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

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