News Article | November 10, 2016
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 | November 24, 2016
(TORONTO, Canada - Nov. 24, 2016) - A team of researchers from the iDAPT labs at Toronto Rehabilitation Institute-University Health Network are dedicated to keeping Canadians safer this winter by offering evidence-based ratings on footwear that may reduce the risk of slips and falls on ice. The team has developed the first test of its kind in the world - the Maximum Achievable Angle (MAA) Testing Method - to validate slip resistant footwear on icy surfaces using real people in a simulated winter environment. With the help of WinterLab, an underground, state-of-the art research facility located at Toronto Rehab, researchers have tested the slip resistance of 98 winter boots, including both safety and casual footwear. The results have been published on http://www. - with only eight per cent of the 98 different types of footwear meeting the minimum slip resistance standards set out by the MAA test. For the first time, consumers will have winter slip resistance ratings available when they purchase winter footwear - similar to the ratings available for winter tires. Consumers are encouraged to request winter footwear they would like to see put to the test. It's estimated that more than 20,000 Ontarians visit the emergency room every year due to injuries related to falling on ice or snow. A recent Toronto Public Health report revealed that over 40 per cent of those aged 35-59 years and 60 per cent of those aged 60-85 years said they would go out less as a way to cope with the winter weather. "This is another example of how research at Toronto Rehab provides practical help to prevent accidents and disability. I expect that many serious and life-changing injuries will be prevented this winter by people choosing to buy better non-slip footwear," says Dr. Geoff Fernie, Research Director, Toronto Rehabilitation Institute. "I also expect the impact to grow with future winters as more manufacturers strive to develop products that score well in our system and can be recommended to consumers." WinterLab has the ability to recreate typical Canadian winter conditions, for example sub-zero temperatures, snow and ice covered surfaces and winds up to 30 km per hour. WinterLab can be tilted to create slopes, or can be moved suddenly to challenge a participant's balance while safely fastened into a harness. The MAA test is conducted in four basic steps: Testing in WinterLab is completed on both bare ice and melting ice to simulate diverse outdoor surfaces Canadians may come across in the winter months. Combined with walking uphill and downhill, four conditions are tested for each pair of footwear. The overall score is based on the minimum performance over the four conditions. Toronto Rehab has created a 'snowflake' scale to rate the slip-resistance of winter footwear. Ontario's accessibility guidelines specify a curb ramp of at most seven degrees. Footwear that achieves at least the minimum angle of seven degrees is awarded one snowflake. Two snowflakes are given for 11 degrees and three snowflakes for 15 degrees - although none of the footwear tested to-date has achieved two or three snowflakes. The most surprising finding was that 90 types of winter footwear tested failed to even achieve seven degrees and could not be awarded any snowflakes. Toronto Rehab researchers have found that two technologies stood out among successful MAA-approved boots - Green Diamond and Arctic Grip. Shoes outfitted with Green Diamond or Arctic Grip soles have special outsole materials designed to provide better traction on wet ice, which may reduce the risk of slips and falls on slippery icy surfaces. These shoes and boots were awarded one snowflake. Researchers are excited by the possibility of providing ratings for winter shoes and working with manufacturers to develop new footwear that functions well on snow and ice. They have been testing footwear prototypes that have scored two and, even, three snowflakes, and hope to see these available for sale within two years. As the world-leading rehabilitation research centre, Toronto Rehabilitation Institute is developing practical solutions to prevent illness and accidents, restore function following a disabling event, and to enable people to continue to live in their own homes and communities as they age. It integrates innovative patient care, ground breaking research and diverse education to build healthier communities and advance the role of rehabilitation in the health system. Toronto Rehab, along with Toronto General and Toronto Western Hospitals, the Princess Margaret Cancer Centre and The Michener Institute of Education at UHN is a member of the University Health Network and is affiliated with the University of Toronto. http://www.
News Article | November 14, 2016
Patients with chronic obstructive pulmonary disease (COPD) would benefit if pulmonary function testing was used more consistently to diagnose the condition, according to a study in CMAJ (Canadian Medical Association Journal) COPD is the third leading cause of death worldwide and affects more than 10% of adults. Testing airflow with pulmonary function testing is a key tool in diagnosing COPD, but it is underused, with only 30% to 50% of people with physician-diagnosed COPD undergoing testing. "Given low rates of testing, these findings point to an opportunity to improve patient outcomes, reduce health services use and decrease health care costs by increasing rates of testing for suspected COPD," writes Dr. Andrea Gershon, Sunnybrook Research Institute and Institute for Clinical Evaluative Sciences (ICES), with coauthors. Researchers looked at data for 68 898 patients diagnosed with COPD between 2005 and 2012, including 16 798 patients with newly diagnosed COPD. Only 41% had received pulmonary function testing, and these patients were more likely to be younger, have seen a specialist and have a primary care physician who followed clinical guidelines for COPD. They were also less likely to have comorbidities. The researchers found that patients who underwent lung function testing as a diagnostic tool were 10.4% less likely to be hospitalized for COPD or to die of any cause compared with patients who did not undergo testing when other differences between these groups were controlled for. They also found an association between lung function testing and increased use of medication for COPD, a finding consistent with previous research. "Our results support the commonly held understanding that pulmonary function testing is key to the accurate diagnosis and quality care of people with COPD," state the authors. They suggest that using this testing more frequently to diagnosis suspected cases of COPD can improve patient outcomes, promote better use of health care services and cut costs. The study was conducted by researchers at ICES, the Sunnybrook Health Sciences Centre, The Hospital for Sick Children (SickKids), the University Health Network and the Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario; and the University of Ottawa, Ottawa, Ontario. It was supported by a grant from the Ontario Lung Association and Pfizer Canada.
PubMed | The Hospital for Sick Children, University Health Network and and University of Toronto
Type: Journal Article | Journal: Clinical journal of the American Society of Nephrology : CJASN | Year: 2015
Standard clinical assessments do not predict surgical intervention in patients with a moderate degree of upper tract hydronephrosis. This study investigated whether combined measures of renal calyceal dilation and anteroposterior diameter (APD) of the renal pelvis at the first postnatal ultrasound better predict surgical intervention beyond standard assessments of the APD or Society of Fetal Urology (SFU) grading system.A retrospective cohort of 348 children with antenatal hydronephrosis followed from 2003 to 2013 were studied. Using Cox regression, the risk for surgery by APD, SFU, and combined grading on the basis of the first postnatal ultrasound was calculated. The predictive capability of each grading system for surgery was determined by calculating the positive likelihood ratio (LR+).The combination of APD6-9 mm and diffuse caliectasis had a hazard ratio (HR) of 19.5 (95% confidence interval [95% CI], 3.94 to 96.9) versus 0.59 (95% CI, 0.05 to 6.53) for APD6-9 mm alone and a similar risk of 8.9 for SFU grade 3 (95% CI, 3.84 to 20.9). The combination of APD9-15 mm and diffuse caliectasis had an HR of 18.7 (95% CI, 4.36 to 80.4) versus 1.75 (95% CI, 0.29 to 10.5) for APD9-15 mm alone. The LR+ for surgery for diffuse caliectasis and APD6-9 mm was higher than for APD6-9 mm alone (HR=2.62; 95% CI, 0.87 to 7.94 versus HR=0.04; 95% CI, 0.01 to 0.32) and was higher for APD9-15 mm and diffuse caliectasis than APD9-15 mm alone (HR=2.0; 95% CI, 1.15 to 3.45 versus HR=0.14; 95% CI, 0.04 to 0.43). Both combined groups of moderate hydronephrosis (APD6-9 mm or 9-15 mm with diffuse caliectasis) had only slightly higher LR+ than SFU grade 3 (HR=1.89; 95% CI, 1.17 to 3.05).These results suggest a grading system combining APD and diffuse caliectasis distinguishes those children with moderate degrees of upper tract hydronephrosis that are at higher risk of surgery.