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NEWARK, Calif., Nov. 10, 2016 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for indications with high unmet medical need, including rare and orphan diseases, today announced that it will host a Key Opinion Leader breakfast on the treatment of Primary Biliary Cholangitis (PBC) at 8:00 am Eastern Time on Wednesday, November 16 in New York City. The meeting will feature keynote presentations by renowned key opinion leaders Gideon Hirschfield, MD, Ph.D., and David Jones, MD, Ph.D., who will present an overview of PBC and the unmet needs that remain to be fulfilled for patients affected with this disease. They will also discuss results from a Phase 2 proof-of-concept study of MBX-8025 in patients with PBC that has been scheduled for late breaker presentation at this year’s Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).  MBX-8025 is an orally administered potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist.  The European Medicines Agency has granted CymaBay PRIority MEdicines (PRIME) status for MBX-8025 for the treatment of PBC. In addition, the FDA has recently granted MBX-8025 an orphan drug designation for the treatment of PBC. CymaBay’s Chief Medical Officer, Pol Boudes, M.D., will also provide an overview of the company’s next Phase 2 study of MBX-8025 in PBC which is expected to initiate by the end of the year. Dr. Hirschfield is a Senior Lecturer and Honorary Consultant Physician in the Centre for Liver Research at the University of Birmingham, UK, one of the largest such programs in Europe.  Dr. Hirschfield was previously a Staff Physician and Assistant Professor of Medicine at the University Health Network and University of Toronto, where he managed one of the largest autoimmune liver disease cohorts in North America. In conjunction with his colleague Prof. Kathy Siminovitch, he published the seminal genetic observations underpinning the IL-12 signaling axis as critical to the pathophysiology of PBC.  He now divides his time between translational research in autoimmune liver disease and his clinical Transplant/Hepatology practice at the Queen Elizabeth Hospital Birmingham, where he manages some of the largest international cohorts of patients with PBC, primary sclerosing cholangitis (PSC), and autoimmune hepatitis (AIH). Dr. Jones is a Professor of Liver Immunology at Newcastle University and an Honorary Consultant Hepatologist on the Liver Transplant Unit at the Freeman Hospital. He is also Director of the Institute of Cellular Medicine in Newcastle, an innovative and multi-disciplinary research institute focused on translational research. In addition, he is Director of Clinical Fellowships in Newcastle and Director of a Wellcome Trust Interdisciplinary Training Programme in Translational Medicine and Therapeutics for Clinicians.  Dr. Jones runs the largest autoimmune liver disease clinical service in the UK. He is a co-author of the European treatment guidelines for autoimmune liver disease. He also established the UK Autoimmune Liver Disease research oversight group, which brings together all of the research programmes in the UK in autoimmune liver disease (UK-PBC, UK-AIH and UK-PSC).  Dr. Jones's primary research interests are in immunology and autoimmune liver disease, including primary biliary cholangitis, primary sclerosing cholangitis and autoimmune hepatitis. The event is intended for institutional investors, sell-side analysts, and business development professionals only.  If you would like to attend in person, please contact Mac MacDonald at 212-915-2567 or via e-mail at Mac@LifeSciAdvisors.com to reserve a place. A live webcast of the event, with slides, will be available at http://lifesci.rampard.com/20161116/reg.jsp and the Investors section of the Company’s website at http://ir.cymabay.com. About CymaBay CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company developing therapies to treat diseases with high unmet medical need, including serious rare and orphan disorders. MBX-8025 is a potent, selective, orally active PPARδ agonist. CymaBay has recently completed a Phase 2 study of MBX-8025 in patients with primary biliary cholangitis as well as a pilot Phase 2 study in patients with homozygous familial hypercholesterolemia, establishing proof-of-concept in both indications.  Previously, a Phase 2 study of MBX-8025 in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile.  Arhalofenate, CymaBay’s other product candidate, is a potential Urate-Lowering Anti-Flare Therapy that has completed five Phase 2 studies in gout patients. Arhalofenate has been found to reduce painful flares in joints while at the same time promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia. Cautionary Statements The statements in this press release, including those statements regarding the structure and conduct of clinical trials, future performance of CymaBay's product candidates, the potential of MBX-8025 to treat primary biliary cholangitis, the therapeutic and commercial potential of CymaBay’s product candidates, and any of the targeted indications for the potential future development or commercialization of CymaBay’s product candidates are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of CymaBay’s product candidates could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials of MBX-8025 and arhalofenate; effects observed in trials to date which may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.


News Article | December 22, 2016
Site: globenewswire.com

Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company"), a medical technology company with a pioneering navigated non-invasive brain stimulation system, today announces a business update for the year ending 31 December 2016. Navigated Brain Stimulation Customer adoption of Navigated Brain Stimulation (NBS) systems for brain mapping is increasing and current users continue to adopt and incorporate the technology into their clinical practice. New customers at various prestigious institutions, world-wide purchasing the technology include: The University of Iowa; Dell Children's Hospital in Austin, Texas; Vivantes Klinikum Neukölln in Germany; Queen Elizabeth Hospital Birmingham in UK, and; Aarhus University Hospital in Denmark. The NBS technology was highlighted in multiple clinical presentations at various scientific congresses including: Society for Neuro-Oncology Annual Meeting; 8th International Symposium on Navigated Brain Stimulation in Neurosurgery and Neuromodulation; Congress of Neurological Surgeons Annual Meeting; Deutsche Gesellschaft für Neurochirurgie; 20th Scandinavian Course in Neurosurgery; European Association of Neurosurgical Societies Congress; 10th Meeting of the European Low Grade Glioma Network; American Epilepsy Society Meeting, and; American Association of Neurological Surgeons Annual Meeting. In line with the Company's strategic direction, progress is being made to partner with independent distributors in the U.S. to advance commercial efforts for Nexstim's NBS for brain mapping. Navigated Brain Therapy As separately announced yesterday, Nexstim received a positive response and comments from the US Food and Drug Administration on its limited size trial protocol for the proposed Post-Stroke Motor Recovery Trial. The positive response paves the way for a new 60 patient trial with Nexstim's Navigated Brain Therapy (NBT®) in 2017 and Nexstim expects to receive de novo 510(k) clearance in Q4 2018. In Europe, commercial steps are being conducted around NBT®, working with early adopter clinicians. Financing The financing arrangement in the form of a joint deal with Bracknor and Sitra continues on track. Since the beginning of the arrangement announced on 18 August 2016, Nexstim has issued new shares worth EUR 7.7 million in total. The current cash and cash generated from sales, the financing arrangements with Bracknor and Sitra, combined with the strategic changes in the organisation, is estimated to finance the Company until early 2018. The full year 2016 financial results will be published on Tuesday, February 28, 2017. Commenting on the business update, Martin Jamieson, CEO of Nexstim, said: "2016 has been a very important year for the Company with significant clinical and financial developments. We continue to make good progress in many key areas and look forward to moving these forward in 2017." Further information is available on the website www.nexstim.com or by telephone: About Nexstim Plc Nexstim is a medical technology company which has pioneered its technology in brain diagnostics with the Navigated Brain Stimulation (NBS) system. It is the first and only FDA cleared and CE marked system based on navigated Transcranial Magnetic Stimulation (nTMS) for pre-surgical mapping of the speech and motor cortices of the brain. Based on the same technology platform, the Company has developed a system called Navigated Brain Therapy (NBT®) which is CE marked for the treatment of chronic neuropathic pain, major depression and stroke. Nexstim shares are listed on the Nasdaq First North Finland and Nasdaq First North Sweden. For more information please visit www.nexstim.com


Stockley R.A.,Queen Elizabeth Hospital Birmingham | Turner A.M.,University of Birmingham
Trends in Molecular Medicine | Year: 2014

The recognition of α-1-antitrypsin deficiency, its function, and its role in predisposition to the development of severe emphysema was a watershed in our understanding of the pathophysiology of the condition. This led to the concept and development of intravenous replacement therapy used worldwide to protect against lung damage induced by neutrophil elastase. Nevertheless, much remained unknown about the deficiency and its impact, although in recent years the genetic and clinical variations in manifestation have provided new insights into assessing impact, efficacy of therapy, and development of new therapeutic strategies, including gene therapy, and outcome measures, such as biomarkers and computed tomography. The current article reviews this progress over the preceding 50 years. © 2013 Elsevier Ltd.


Sharif A.,Queen Elizabeth Hospital Birmingham | Borrows R.,Queen Elizabeth Hospital Birmingham | Borrows R.,University of Birmingham
American Journal of Kidney Diseases | Year: 2013

Delayed graft function continues to pose a significant challenge to clinicians in the context of kidney transplantation. With the present disparity between supply and demand for organs, transplantation is proceeding with more marginal kidneys and therefore the problem of delayed graft function is likely to increase in the future. Although our understanding of the mechanism and risk factors for delayed graft function has improved, translation of this understanding into targeted clinical therapy to attenuate or manage established delayed graft function has been elusive. Based on current trends, the use of kidneys from expanded criteria or cardiac death donors will continue to expand, which will increase the prevalence of delayed graft function in the immediate postoperative setting. The aim of this article is to discuss and critique the available clinical evidence for targeted intervention in the prevention and management of delayed graft function and review emerging and experimental therapies. © 2013 National Kidney Foundation, Inc.


Forbes S.J.,University of Edinburgh | Newsome P.N.,Queen Elizabeth Hospital Birmingham | Newsome P.N.,University of Birmingham
Journal of Hepatology | Year: 2012

There is an increasing range of potential applications of stem cells in liver diseases, with many clinical studies already undertaken. We identify four of the main areas which we propose stem cell therapy could be a realistic aim for in the future: (1) to improve regeneration and reduce scarring in liver cirrhosis by modulating the liver's own regenerative processes, (2) to down-regulate immune mediated liver damage, (3) supplying hepatocyte-like cells (HLCs) derived from stem cells for use in extracorporeal bio-artificial liver machines, and (4) to use stem cell derived HLCs for cell transplantation to supplement or replace hepatocyte function. © 2011 Published by Elsevier B.V. on behalf of the European Association for the Study of the Liver.


Aims: To create an inclusive and accurate registry of all percutaneous coronary intervention (PCI) procedures performed in the UK for audit to assess quality of care, drive improvements in this care and to provide data for research. Interventions: Feedback to PCI centres with 'live' online data analysis and structured monthly and quarterly reports of PCI activity, including process of care measures and assessment of risk-adjusted outcome. Annual national reports focused on the structure of the provision of PCI across the UK, the appropriateness and process of its delivery and outcomes. Setting: All hospitals performing PCI in the UK. Years: 1994 to present. Population: Consecutive patients treated by PCI. Approximately 80 000 new procedures each year in recent years. Startpoints: All attempts to perform a PCI procedure. This is defined as when any coronary device is used to approach, probe or cross one or more coronary lesions, with the intention of performing a coronary intervention. Baseline data: 113 variables defining patient demographic features, indications for PCI, procedural details and outcomes up to time of hospital discharge. Data capture: Data entry into local software systems by caregivers and data clerks, with subsequent encryption and internet transfer to central data servers. Data quality: Local validation, range checks and consistency assessments during upload. No external validation. Feedback of data completeness to all units. Access to data: Available for research by application to British Cardiovascular Intervention Society using a data sharing agreement which can be obtained at http://www.bcis.org.uk.


Stockley R.A.,Queen Elizabeth Hospital Birmingham
International Journal of COPD | Year: 2014

The field of biomarker research has almost reached unmanageable proportions in chronic obstructive pulmonary disease (COPD). The developments of new technology platforms have generated a huge information data base, both cross sectionally and increasingly, longitudinally. The knowledge emerging provides an enormous potential for understanding the disease pathophysiology, for developing markers specific for long-term outcomes, and for developing new therapeutic strategies. However, the excitement must be tempered with an understanding of the limitations of the data collection techniques, and of the variations in disease state, activity, impact, and progression. Nevertheless, the most crucial aspect in interpreting the current literature is the recognition of the relatively superficial characterization of what is a complex group of pathological processes with a common end point of airflow limitation. The current review explores some of these issues together with those areas where real progress appears to have been made, and provides caution on interpretation. © 2014 Stockley.


Stockley R.A.,Queen Elizabeth Hospital Birmingham
Chest | Year: 2013

The first five cases of α1-antitrypsin deficiency were originally published in 1963. This changed our whole concept about the pathophysiology of emphysema, including the role of inflammation and, in particular, the role of proteolytic enzymes. However, the observation also had a significant 50-year impact on many aspects of protein biochemistry, genetics, cell biology, and disease concepts outside the lung as well as the study of COPD in general. © 2013 American College of Chest Physicians.


Perera M.T.P.R.,Queen Elizabeth Hospital Birmingham
Current Opinion in Organ Transplantation | Year: 2012

PURPOSE OF REVIEW: Follow-up data from donors following cardiac death (DCD) liver transplants suggest an increased risk of graft failure and morbid complications, and the risk increased with grafts from marginal donors. Donor warm ischaemia (dWIT) stands out as the common aetiological factor. Aim of this review is to examine if super-rapid technique had developed sufficiently enough to improve the effects of dWIT that had been started since treatment withdrawal in category III DCD marginal donors. RECENT FINDINGS: The recent findings suggest limited evolvement, but these have not been contributed to reduce dWIT significantly. Evidence suggests hypoperfusion and circulatory stop occurring well before electrophysical inactivity; hence, dWIT is probably underestimated. Time spent since cardiac death to aortic cross clamp is directly linked to ischaemic complications; limited modifications to surgical technique alone have failed to make an impact on these complications. Marginal grafts generally perform worse, increasing the overall financial cost of patient management. SUMMARY: Irrespective of the speed at which aortic perfusion is instituted, the technical developments have not been able to improve outcomes/utility of marginal DCD grafts. The future of the DCD programmes should explore the means of reviving organ damage incurred during dWIT that are incorporated to the super-rapid technique of organ harvest. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Stockley R.A.,Queen Elizabeth Hospital Birmingham
Clinics in Chest Medicine | Year: 2014

Alpha1-antitrypsin (AAT) deficiency was first described in 1963 together with its associations with severe early-onset basal panacinar emphysema. The genetic defects leading to deficiency have been elucidated and the pathophysiologic processes, clinical variation in phenotype, and the role of genetic modifiers have been recognized. Strategies to increase plasma (and hence tissue) concentrations of AAT have been developed. The only recognized specific therapeutic strategy is regular infusions of the purified plasma protein, and evidence confirms its efficacy in protecting the lung (at least partially). Early detection and modification of lifestyle remains crucial to the management of AAT deficiency. © 2014 Elsevier Inc.

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