Columbia Presbyterian Medical Center

Fort Washington, NY, United States

Columbia Presbyterian Medical Center

Fort Washington, NY, United States

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Results from the REVEAL AF Study Show That AF Would Have Gone Undetected in the Majority of Patients at High-Risk for AF and Stroke If Cardiac Monitoring Was Limited to 30 Days DUBLIN and CHICAGO - May 12, 2017 - Medtronic plc (NYSE: MDT) today announced results from a new clinical study showing Medtronic Insertable Cardiac Monitors (ICM) detected a high incidence of atrial fibrillation (AF) in patients previously undiagnosed but suspected to be at high-risk for AF and stroke. These data from the REVEAL AF (Incidence of AF in High Risk Patients) study were presented today during a late-breaking session at Heart Rhythm 2017, the Heart Rhythm Society's 38th Annual Scientific Sessions. The study found that at 18 months, continuous monitoring with either the Reveal® XT ICM or the Reveal LINQ(TM) ICM resulted in an AF detection rate of 29.3 percent among previously undiagnosed high-risk patients (based on clinical risk factors). The data showed continuous monitoring with an ICM detected AF beyond 18 months with a detection rate of 40 percent at 30 months. Additionally, 6.2 percent of patients were diagnosed with AF at 30 days, indicating that more than three-quarters of high risk patients with AF would have gone undetected with only 30 days of cardiac monitoring. The median time from device insertion to the first AF episode was 123 days, which is outside the range of conventional external monitoring. The Reveal AF study also evaluated how physicians managed patients when AF was found. At least one clinical action was taken in 75.7 percent of patients who were diagnosed with AF (at 18 months). More than half (56.3 percent) of patients diagnosed with AF were prescribed oral anticoagulation by their physicians, which has been shown to significantly reduce stroke risk. This suggests that the information provided by the Reveal ICM was clinically meaningful. "Detection of AF utilizing minimally invasive insertable cardiac monitors in a high-risk population combined with appropriate AF treatment could prevent many initial strokes," said James Reiffel, M.D., principal investigator of the REVEAL AF Study and professor emeritus of medicine, Department of Medicine, Division of Cardiology at the Columbia Presbyterian Medical Center in New York City. "Findings from the REVEAL AF study show that the rate of AF in patients at high-risk for AF and thus stroke but with no prior history of AF is significant, raising important public health implications on early screening and prevention of stroke in this demographic group." AF is a common cardiac condition impacting millions worldwide in which the heart beats irregularly or rapidly.1 Patients with AF are five times more likely to have a stroke2 due to small blood clots that may form in the heart and subsequently travel to the brain. Failure to recognize and treat AF can lead to strokes, however, because AF often has no symptoms and may occur infrequently, it may not be detected by conventional cardiac monitoring techniques such as in-hospital monitoring, electrocardiography or traditional ambulatory cardiac monitors such as a Holter.3-6 Unlike conventional monitoring methods, the Reveal LINQ ICM with TruRhythm(TM) Detection automatically and continuously detect and record abnormal heart rhythms for up to three years. "AF is often undetected with conventional methods and only first diagnosed after the occurrence of a serious complication such as stroke which can result in significant impact to quality of life and even death," said Robert Kowal, M.D., Ph.D., vice president and medical director of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. "The REVEAL AF study provides important information to influence how physicians monitor high-risk patients to screen and treat AF, potentially preventing stroke from occurring." REVEAL AF was a prospective, single-arm, multi-center study that sought to understand the incidence of adjudicated AF that lasted six minutes or more in high-risk patients who were previously undiagnosed with AF. The primary endpoint of the REVEAL AF study was AF detection rate at 18 months. A total of 385 patients received a Reveal XT ICM or a Reveal ICM and met the primary endpoint cohort definition. Patients were followed for a minimum of 18 months to monitor for AF, or up to a maximum of 30 months. One-third the size of an AAA battery (~1 cc), the Reveal LINQ ICM is inserted using a minimally invasive procedure and its presence is often nearly undetectable to the naked eye once the incision has healed. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink® network and is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed. Earlier this year, Medtronic received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ ICM with TruRhythm Detection which features improved accuracy to better identify abnormal heartbeats. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 1 Chugh S, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014; 129:837-847. 2 Wolf PA, et al. Stroke. 1991; 22: 983-988. 3 Healey JS, Connolly SJ, Gold MR, et al. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012;366:120-129. 4 Seet RC, Friedman PA, Rabinstein AA. Prolonged rhythm monitoring for the detection of occult paroxysmal atrial fibrillation in ischemic stroke of unknown cause. Circulation. 2011;124:477-486. 5 Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006;3:1445-1452. 6 Ziegler PD, Glotzer TV, Daoud EG, et al. Detection of previously undiagnosed atrial fibrillation in patients with stroke risk factors and usefulness of continuous monitoring in primary stroke prevention. Am J Cardiol.2012;110:1309-1314.


Results from the REVEAL AF Study Show That AF Would Have Gone Undetected in the Majority of Patients at High-Risk for AF and Stroke If Cardiac Monitoring Was Limited to 30 Days DUBLIN and CHICAGO - May 12, 2017 - Medtronic plc (NYSE: MDT) today announced results from a new clinical study showing Medtronic Insertable Cardiac Monitors (ICM) detected a high incidence of atrial fibrillation (AF) in patients previously undiagnosed but suspected to be at high-risk for AF and stroke. These data from the REVEAL AF (Incidence of AF in High Risk Patients) study were presented today during a late-breaking session at Heart Rhythm 2017, the Heart Rhythm Society's 38th Annual Scientific Sessions. The study found that at 18 months, continuous monitoring with either the Reveal® XT ICM or the Reveal LINQ(TM) ICM resulted in an AF detection rate of 29.3 percent among previously undiagnosed high-risk patients (based on clinical risk factors). The data showed continuous monitoring with an ICM detected AF beyond 18 months with a detection rate of 40 percent at 30 months. Additionally, 6.2 percent of patients were diagnosed with AF at 30 days, indicating that more than three-quarters of high risk patients with AF would have gone undetected with only 30 days of cardiac monitoring. The median time from device insertion to the first AF episode was 123 days, which is outside the range of conventional external monitoring. The Reveal AF study also evaluated how physicians managed patients when AF was found. At least one clinical action was taken in 75.7 percent of patients who were diagnosed with AF (at 18 months). More than half (56.3 percent) of patients diagnosed with AF were prescribed oral anticoagulation by their physicians, which has been shown to significantly reduce stroke risk. This suggests that the information provided by the Reveal ICM was clinically meaningful. "Detection of AF utilizing minimally invasive insertable cardiac monitors in a high-risk population combined with appropriate AF treatment could prevent many initial strokes," said James Reiffel, M.D., principal investigator of the REVEAL AF Study and professor emeritus of medicine, Department of Medicine, Division of Cardiology at the Columbia Presbyterian Medical Center in New York City. "Findings from the REVEAL AF study show that the rate of AF in patients at high-risk for AF and thus stroke but with no prior history of AF is significant, raising important public health implications on early screening and prevention of stroke in this demographic group." AF is a common cardiac condition impacting millions worldwide in which the heart beats irregularly or rapidly.1 Patients with AF are five times more likely to have a stroke2 due to small blood clots that may form in the heart and subsequently travel to the brain. Failure to recognize and treat AF can lead to strokes, however, because AF often has no symptoms and may occur infrequently, it may not be detected by conventional cardiac monitoring techniques such as in-hospital monitoring, electrocardiography or traditional ambulatory cardiac monitors such as a Holter.3-6 Unlike conventional monitoring methods, the Reveal LINQ ICM with TruRhythm(TM) Detection automatically and continuously detect and record abnormal heart rhythms for up to three years. "AF is often undetected with conventional methods and only first diagnosed after the occurrence of a serious complication such as stroke which can result in significant impact to quality of life and even death," said Robert Kowal, M.D., Ph.D., vice president and medical director of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. "The REVEAL AF study provides important information to influence how physicians monitor high-risk patients to screen and treat AF, potentially preventing stroke from occurring." REVEAL AF was a prospective, single-arm, multi-center study that sought to understand the incidence of adjudicated AF that lasted six minutes or more in high-risk patients who were previously undiagnosed with AF. The primary endpoint of the REVEAL AF study was AF detection rate at 18 months. A total of 385 patients received a Reveal XT ICM or a Reveal ICM and met the primary endpoint cohort definition. Patients were followed for a minimum of 18 months to monitor for AF, or up to a maximum of 30 months. One-third the size of an AAA battery (~1 cc), the Reveal LINQ ICM is inserted using a minimally invasive procedure and its presence is often nearly undetectable to the naked eye once the incision has healed. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink® network and is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed. Earlier this year, Medtronic received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ ICM with TruRhythm Detection which features improved accuracy to better identify abnormal heartbeats. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 1 Chugh S, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014; 129:837-847. 2 Wolf PA, et al. Stroke. 1991; 22: 983-988. 3 Healey JS, Connolly SJ, Gold MR, et al. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012;366:120-129. 4 Seet RC, Friedman PA, Rabinstein AA. Prolonged rhythm monitoring for the detection of occult paroxysmal atrial fibrillation in ischemic stroke of unknown cause. Circulation. 2011;124:477-486. 5 Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006;3:1445-1452. 6 Ziegler PD, Glotzer TV, Daoud EG, et al. Detection of previously undiagnosed atrial fibrillation in patients with stroke risk factors and usefulness of continuous monitoring in primary stroke prevention. Am J Cardiol.2012;110:1309-1314.


Results from the REVEAL AF Study Show That AF Would Have Gone Undetected in the Majority of Patients at High-Risk for AF and Stroke If Cardiac Monitoring Was Limited to 30 Days DUBLIN and CHICAGO - May 12, 2017 - Medtronic plc (NYSE: MDT) today announced results from a new clinical study showing Medtronic Insertable Cardiac Monitors (ICM) detected a high incidence of atrial fibrillation (AF) in patients previously undiagnosed but suspected to be at high-risk for AF and stroke. These data from the REVEAL AF (Incidence of AF in High Risk Patients) study were presented today during a late-breaking session at Heart Rhythm 2017, the Heart Rhythm Society's 38th Annual Scientific Sessions. The study found that at 18 months, continuous monitoring with either the Reveal® XT ICM or the Reveal LINQ(TM) ICM resulted in an AF detection rate of 29.3 percent among previously undiagnosed high-risk patients (based on clinical risk factors). The data showed continuous monitoring with an ICM detected AF beyond 18 months with a detection rate of 40 percent at 30 months. Additionally, 6.2 percent of patients were diagnosed with AF at 30 days, indicating that more than three-quarters of high risk patients with AF would have gone undetected with only 30 days of cardiac monitoring. The median time from device insertion to the first AF episode was 123 days, which is outside the range of conventional external monitoring. The Reveal AF study also evaluated how physicians managed patients when AF was found. At least one clinical action was taken in 75.7 percent of patients who were diagnosed with AF (at 18 months). More than half (56.3 percent) of patients diagnosed with AF were prescribed oral anticoagulation by their physicians, which has been shown to significantly reduce stroke risk. This suggests that the information provided by the Reveal ICM was clinically meaningful. "Detection of AF utilizing minimally invasive insertable cardiac monitors in a high-risk population combined with appropriate AF treatment could prevent many initial strokes," said James Reiffel, M.D., principal investigator of the REVEAL AF Study and professor emeritus of medicine, Department of Medicine, Division of Cardiology at the Columbia Presbyterian Medical Center in New York City. "Findings from the REVEAL AF study show that the rate of AF in patients at high-risk for AF and thus stroke but with no prior history of AF is significant, raising important public health implications on early screening and prevention of stroke in this demographic group." AF is a common cardiac condition impacting millions worldwide in which the heart beats irregularly or rapidly.1 Patients with AF are five times more likely to have a stroke2 due to small blood clots that may form in the heart and subsequently travel to the brain. Failure to recognize and treat AF can lead to strokes, however, because AF often has no symptoms and may occur infrequently, it may not be detected by conventional cardiac monitoring techniques such as in-hospital monitoring, electrocardiography or traditional ambulatory cardiac monitors such as a Holter.3-6 Unlike conventional monitoring methods, the Reveal LINQ ICM with TruRhythm(TM) Detection automatically and continuously detect and record abnormal heart rhythms for up to three years. "AF is often undetected with conventional methods and only first diagnosed after the occurrence of a serious complication such as stroke which can result in significant impact to quality of life and even death," said Robert Kowal, M.D., Ph.D., vice president and medical director of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. "The REVEAL AF study provides important information to influence how physicians monitor high-risk patients to screen and treat AF, potentially preventing stroke from occurring." REVEAL AF was a prospective, single-arm, multi-center study that sought to understand the incidence of adjudicated AF that lasted six minutes or more in high-risk patients who were previously undiagnosed with AF. The primary endpoint of the REVEAL AF study was AF detection rate at 18 months. A total of 385 patients received a Reveal XT ICM or a Reveal ICM and met the primary endpoint cohort definition. Patients were followed for a minimum of 18 months to monitor for AF, or up to a maximum of 30 months. One-third the size of an AAA battery (~1 cc), the Reveal LINQ ICM is inserted using a minimally invasive procedure and its presence is often nearly undetectable to the naked eye once the incision has healed. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink® network and is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed. Earlier this year, Medtronic received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ ICM with TruRhythm Detection which features improved accuracy to better identify abnormal heartbeats. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 1 Chugh S, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014; 129:837-847. 2 Wolf PA, et al. Stroke. 1991; 22: 983-988. 3 Healey JS, Connolly SJ, Gold MR, et al. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012;366:120-129. 4 Seet RC, Friedman PA, Rabinstein AA. Prolonged rhythm monitoring for the detection of occult paroxysmal atrial fibrillation in ischemic stroke of unknown cause. Circulation. 2011;124:477-486. 5 Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006;3:1445-1452. 6 Ziegler PD, Glotzer TV, Daoud EG, et al. Detection of previously undiagnosed atrial fibrillation in patients with stroke risk factors and usefulness of continuous monitoring in primary stroke prevention. Am J Cardiol.2012;110:1309-1314.


Armstrong A.J.,Duke University | Eisenberger M.A.,Johns Hopkins University | Halabi S.,Duke University | Oudard S.,University of Paris Descartes | And 4 more authors.
European Urology | Year: 2012

Context: We have recently witnessed a rapid increase in the number of effective systemic agents for men with metastatic castration-resistant prostate cancer (CRPC), including novel hormonal therapies (abiraterone acetate and MDV3100), immunotherapies (sipuleucel-T), chemotherapies (cabazitaxel), and bone microenvironment targeting agents (denosumab, radium 223). Given the increasing complexity of treatment decisions for this disease, major research and clinical priorities are (1) finding biomarkers that enable an understanding of the natural history and complex biology of this heterogeneous malignancy, (2) defining predictive biomarkers that identify men most likely to benefit from a given therapy, and (3) identifying biomarkers of early response or progression to optimize outcomes. Objective: In this review, we discuss existing and potential biomarkers in CRPC and how they may currently inform prognosis, aid in treatment selection (predictive value), and relate to survival outcomes (surrogacy). Evidence acquisition: PubMed-based literature searches and abstracts through September 2011 provided the basis for this literature review as well as expert opinion. Evidence synthesis: We address blood and urine-based biomarkers such as prostate-specific antigen, lactate dehydrogenase, total and bone alkaline phosphatase and other bone turnover markers, hemoglobin, and circulating tumor cells in the context of prognosis, prediction, and patient selection for therapy. Given the inherent problems associated with defining progression-free survival in CRPC, the importance of biomarker development and the needed steps are highlighted. We place the discussion of biomarkers within the context of the design/intent of a trial and mechanism of action of a given systemic therapy. We discuss novel biomarker development and the pathway for surrogate or predictive biomarkers to become credentialed as useful tests that inform therapeutic decisions. Conclusions: A greater understanding of biomarkers in CRPC permits a more personalized approach to care that maximizes benefit and minimizes harm and can inform clinical trials tailored to men most likely to derive benefit. © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.


Publication outlines strong rationale for combining TGR-1202 and carfilzomib in the recently announced combination study in both indolent and aggressive lymphomas NEW YORK, Oct. 27, 2016 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) announced the publication of preclinical data describing the synergy of the Company’s next generation, once daily, PI3K-delta inhibitor, TGR-1202, with the proteasome inhibitor carfilzomib and the unique effects of the combination to silence c-Myc in various preclinical lymphoma and myeloma models.  In addition, the manuscript also, for the first time, reports on TGR-1202’s unique complimentary mechanism of inhibiting the protein kinase casein kinase-1 (CK1) epsilon, which may contribute to the silencing of c-Myc and explain TGR-1202’s clinical activity in aggressive lymphoma, including Diffuse Large B-cell Lymphoma (DLBCL). The preclinical data are described further in the manuscript titled, “Silencing c-Myc Translation as a Therapeutic Strategy through Targeting PI3K Delta and CK1 Epsilon in Hematological Malignancies,” which was published online yesterday in the First Edition section of Blood, the Journal of the American Society of Hematology.  The online version of the article can be accessed at www.bloodjournal.org. "We want to thank Dr. Deng, Dr. O’Connor, and the team from Columbia Presbyterian Medical Center and the Center for Lymphoid Malignancies for their exhaustive and comprehensive interrogation of TGR-1202 and the elucidation of this novel complimentary mechanism.  For quite some time we have been presenting the differentiated safety profile observed with TGR-1202 and the differentiated chemical structure compared to other PI3K-delta inhibitors.  This preclinical work demonstrates that TGR-1202 not only potently targets PI3K-delta but in addition uniquely targets a relatively novel kinase, CK1-epsilon, which perhaps offers another rationale for the differentiated activity and safety effects we have seen in patients.  We look forward to exploring this exciting concept further in the recently launched clinical trial,” stated Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer. “The data in this paper clearly demonstrates that TGR-1202 and carfilzomib in combination is markedly synergistic and selectively silenced c-Myc compared to combinations with idelalisib and bortezomib.  In addition, we were excited to identify and elucidate the previously unknown mechanism of TGR-1202 and its effect on CK1 epsilon which was not exhibited by either idelalisib or duvelisib based on a kinome profiling platform analyzed.  We believe this research may help explain in part the preliminary activity demonstrated by TGR-1202 in DLBCL.  Given TGR-1202’s distinct safety profile as a single agent and its uniquely demonstrated ability to be used in combination with other agents, we look forward to bringing this novel combination to the clinic in our recently announced Phase 1 study of TGR-1202 and carfilzomib in patients with lymphoma,” stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center. Based on this extensive preclinical work, the Company recently announced the launch of a Phase 1/2 study to evaluate the safety and efficacy of TGR-1202 in combination with carfilzomib, in patients with relapsed or refractory lymphoma, particularly c-Myc driven lymphomas which are aggressive in nature.  This study is currently open to enrollment at the Center for Lymphoid Malignancies, Columbia Presbyterian Medical Center, New York, NY.  More information on this clinical study can be found at www.clinicaltrials.gov. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has preclinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Some of the statements included in this press release, particularly those with respect to current or future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete preclinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies; the risk that early preclinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies or combination trials which include any of the aforementioned product candidates will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior preclinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


SAN DIEGO, Dec. 05, 2016 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), announced the presentation yesterday of two preclinical data sets, one oral presentation and one poster presentation, for TGR-1202, the Company’s once-daily PI3K delta inhibitor, at the 58th American Society of Hematology (ASH) annual meeting in San Diego, California. Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, stated, "We want to thank the teams at Columbia and Moffitt for their extensive laboratory work on TGR-1202 to better understand the mechanism of action and impact on the immune system.  The preclinical data they have generated helps to better explain and perhaps offer a rationale for the differentiated safety profile seen with TGR-1202 as compared to earlier generation PI3K delta inhibitors.  We believe these preclinical findings along with the robust safety and efficacy data we have observed in the clinic, support our belief that TGR-1202 is a differentiated best in class PI3K delta inhibitor.  We look forward to continuing our research collaborations with Columbia and Moffitt and to presenting updated safety and efficacy data for TGR-1202 to further confirm its unique profile.” “Dr. Deng's presentation today has really begun to shed some long-needed light on the important differences among the PI3K delta inhibitors. His work has identified that a novel kinase important in the PI3K pathway, CK-1epsilon, is uniquely inhibited by TGR-1202, which may explain the drug’s effects on c-Myc. These chemical differences may also help to explain the important immunologic differences in the safety profiles of these agents,” stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center. The following summarizes the oral presentation and poster presentation which occurred yesterday: Oral Presentation: Silencing c-Myc Translation as a Therapeutic Strategy through Targeting PI3K Delta and CK1 Epsilon in Hematological Malignancies (Abstract Number 291) This oral presentation includes data from the manuscript titled, “Silencing c-Myc Translation as a Therapeutic Strategy through Targeting PI3K Delta and CK1 Epsilon in Hematological Malignancies,” which was recently published in Blood, the Journal of the American Society of Hematology.  The presentation was delivered by Changchung Deng, MD, PhD of Columbia Presbyterian Medical Center and included the following highlights: Poster Presentation: Modulation of T Cell Compartment in a Preclinical CLL Murine Model By a Selective PI3K Delta Inhibitor, TGR-1202 (Abstract Number 3236) This poster presentation included preclinical data describing the differential regulation of human T-cells by TGR-1202 in a preclinical CLL murine model. Highlights from this poster include: PRESENTATION DETAILS: Copies of the above referenced presentations are available on the Company’s website at www.tgtherapeutics.com, located on the Publications page. TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS: TG Therapeutics will also host an investor and analyst reception on Monday, December 5th, 2016 beginning at 8:00pm PT.  The event will take place at the Marriott Gaslamp, in San Diego, California, in the Presidio AB Ballroom.  NOTE: This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review.   This event will also be broadcast via conference call.  In order to access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics 2016 Investor & Analyst Event. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete preclinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies; the risk that early preclinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior preclinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. TGTX - G


Cauley K.A.,Columbia Presbyterian Medical Center | Cataltepe O.,University of Massachusetts Medical School
American Journal of Roentgenology | Year: 2014

OBJECTIVE. Hydrocephalus causes changes in the diffusion-tensor properties of periventricular white matter. Understanding the nature of these changes may aid in the diagnosis and treatment planning of this relatively common neurologic condition. Because ventricular size is a common measure of the severity of hydrocephalus, we hypothesized that a quantitative correlation could be made between the ventricular size and diffusion-tensor changes in the periventricular corona radiata. In this article, we investigated this relationship in adult patients with hydrocephalus and in healthy adult subjects. MATERIALS AND METHODS. Diffusion-tensor imaging metrics of the corona radiata were correlated with ventricular size in 14 adult patients with acute hydrocephalus, 16 patients with long-standing hydrocephalus, and 48 consecutive healthy adult subjects. Regression analysis was performed to investigate the relationship between ventricular size and the diffusion-tensor metrics of the corona radiata. Subject age was analyzed as a covariable. RESULTS. There is a linear correlation between fractional anisotropy of the corona radiata and ventricular size in acute hydrocephalus (r = 0.784, p < 0.001), with positive correlation with axial diffusivity (r = 0.636, p = 0.014) and negative correlation with radial diffusivity (r = 0.668, p = 0.009). In healthy subjects, axial diffusion in the periventricular corona radiata is more strongly correlated with ventricular size than with patient age (r = 0.466, p < 0.001, compared with r = 0.058, p = 0.269). CONCLUSION. Axial diffusivity of the corona radiata is linearly correlated with ventricular size in healthy adults and in patients with hydrocephalus. Radial diffusivity of the corona radiata decreases linearly with ventricular size in acute hydrocephalus but is not significantly correlated with ventricular size in healthy subjects or in patients with long-standing hydrocephalus. © American Roentgen Ray Society.


Nikulina V.,John Jay College of Criminal Justice | Nikulina V.,Columbia Presbyterian Medical Center | Widom C.S.,John Jay College of Criminal Justice | Czaja S.,John Jay College of Criminal Justice
American Journal of Community Psychology | Year: 2011

This study examines the roles of childhood neglect and childhood poverty (family and neighborhood) in predicting Posttraumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD), academic achievement, and crime in young adulthood. Using existing data from a prospective cohort design study, 1,005 children with documented histories of neglect (N = 507) and matched controls (N = 497) were interviewed in young adulthood (mean age 29). Official criminal histories were also used to assess outcomes. Data were analyzed using logistic and ordinary least squares regressions and hierarchical linear modeling (HLM) to control for neighborhood clustering. Results from HLM revealed that childhood neglect and childhood family poverty uniquely predicted PTSD and adult arrest, MDD was predicted only by childhood family poverty, and a significant interaction between childhood family poverty and childhood neighborhood poverty predicted academic achievement for the control group only. Childhood neglect, childhood family poverty, and childhood neighborhood poverty each contribute to poor outcomes later in life. While interventions should be developed for neglected children to prevent negative outcomes, the current findings suggest that it is also important to consider the ecological context in which these children are growing up. © 2010 Society for Community Research and Action.


Byram I.R.,Columbia Presbyterian Medical Center | Kim H.M.,Columbia Presbyterian Medical Center | Levine W.N.,Columbia Presbyterian Medical Center | Ahmad C.S.,Columbia Presbyterian Medical Center
American Journal of Sports Medicine | Year: 2013

Elbow arthroscopic surgery can now effectively treat a variety of conditions that affect athletes. Advances in instrumentation, increased surgeon familiarity, and expanded indications have led to significant growth in elbow arthroscopic surgery in the past few decades. While positioning, portal placement, and specific instruments may vary among surgeons, anatomic considerations guide surgical approaches to minimize neurovascular compromise. Arthroscopic procedures vary in difficulty, and surgeons should follow stepwise advancement with experience. Removal of loose bodies, debridement of synovial plicae, and debridement of the extensor carpi radialis brevis for lateral epicondylitis are considered simple procedures for novice elbow arthroscopic surgeons. More advanced procedures include management of osteochondritis dissecans, valgus extension overload in the throwing athlete, and capsular release. With proper technique, a variety of athletic elbow conditions can be treated arthroscopically with predictable results and minimal morbidity. © 2013 The Author(s).


NEW YORK, Feb. 21, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) announced the publication of clinical data from a Phase 1/2 trial of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) previously exposed to rituximab. The data demonstrates single agent TG-1101 to be well tolerated with the most common adverse event observed being grade 1/2 infusion related reactions (IRR), with no grade 3/4 IRRs.  TG-1101 monotherapy was active, with a 45% overall response rate (ORR) observed among heavily pretreated patients with NHL and CLL, including those who were refractory to prior anti-CD20 based therapy.  These data are described further in the manuscript titled, “A phase 1/2 trial of ublituximab, a novel, glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab,” which was published online today in the British Journal of Haematology. The online version of the article can be accessed at http://onlinelibrary.wiley.com/doi/10.1111/bjh.14534/full. “We want to thank Dr. Owen O’Connor, and the team from Columbia Presbyterian Medical Center and the Center for Lymphoid Malignancies for their work on this Phase 1/2 trial of single agent TG-1101 and congratulate them on the publication of these data.  Since the inception of our Company, we have been focused on developing best-in-class agents with the goal of building novel combination therapies.  This single agent data illustrates that TG-1101 is a safe and highly-active anti-CD20 monoclonal antibody on top of which additional treatments can be layered.  The safety profile, speed of infusion, and response rates observed, with single agent TG-1101, especially in rituximab-refractory patients, serve as a foundation for our belief that TG-1101 is a best-in-class anti-CD20 monoclonal antibody,” stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics.  Mr. Weiss continued, “These Phase 1/2 data, as well as the combination data of TG-1101 plus ibrutinib published in the British Journal of Haematology late last year, further support our Phase 3 GENUINE trial of TG-1101 in combination with ibrutinib and we look forward to presenting top-line data from this study in the first half of this year.” “The addition of an anti-CD20 monoclonal antibody to other treatments, whether chemo-based or novel targeted therapies, has demonstrated to be an impactful way to enhance responses for patients with NHL and CLL.  Acquired resistance to rituximab is a significant clinical issue for which many patients need an alternative effective agent to overcome the resistance. We are highly encouraged by the results we have seen in the clinic with ublituximab and believe the drug’s safety profile, as well as shortened infusion times as compared to other anti-CD20s, can provide meaningful benefit to patients,” stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Some of the statements included in this press release, particularly those with respect to anticipating the timing of the completion of the GENUINE study, timing of top-line data for the GENUINE study, the usability of the results from GENUINE for accelerated approval, timing of initial data from the UNITY-DLBCL study, timing of the release of data and commencement of our MS pivotal program may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete the GENUINE, the UNITY-CLL or the UNITY-DLBCL trials; the risk that the clinical results from the GENUINE, UNITY-CLL and/or UNITY-DLBCL studies will be not positive and/or will not support regulatory approval of TG-1101 or TGR-1202; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk that we will not file a BLA for TG-1101 or an NDA for TGR-1202 based on either the GENUINE or the UNITY-CLL; the risk that despite early positive trends in enrollment in the UNITY-CLL study that enrollment will be delayed beyond our projections; the risk that the planned interim analysis will not allow early closure of the single agent arms in the UNITY-CLL study, necessitating enrollment beyond the projected 450 patients, which would extend enrollment beyond our projections; the risk that safety issues or trends will be observed in the GENUINE study, the UNITY-CLL and/or the UNITY-DLBCL study that prevent approval of either TG-1101 and/or TGR-1202 or require us to terminate either the GENUINE study or the UNITY-CLL or the UNITY-DLBCL study prior to completion; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that the GENUINE study, as amended or the UNITY-CLL or the UNITY-DLBCL studies, or any of our other registration-directed clinical trials as designed or amended may not be sufficient or acceptable to support regulatory approval; the risk that trials will take longer to enroll than expected; the risk that the projected cost savings to be realized by amending the GENUINE trial will not be realized; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

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