Hospital Universitario

Rio de Janeiro, Brazil

Hospital Universitario

Rio de Janeiro, Brazil
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News Article | April 18, 2017
Site: www.prnewswire.co.uk

CARLSBAD, California, 18 de abril de 2017 /PRNewswire/ -- Thermo Fisher Scientific ha firmado un acuerdo con el Instituto de Genética Médica y Patología del Hospital Universitario de Basilea, Suiza, para establecer a la distinguida institución como primer socio del Next Generation Sequencing Companion Dx Center of Excellence Program (Programa de centro de excelencia de secuenciación de próxima generación y diagnósticos complementarios), una nueva iniciativa diseñada para desarrollar y perfeccionar las pruebas de investigación basadas en NGS de su cartera oncológica Oncomine™ con el propósito de introducirlos eventualmente en la clínica como diagnósticos complementarios. Como parte del acuerdo, ambas organizaciones trabajarán conjuntamente para forjar alianzas internacionales y asociaciones estratégicas con grupos biofarmacéuticos y otros a fin de acelerar los ensayos en oncología e inmuno-oncología. Además, el Instituto de Genética Médica y Patología, gestionado por el doctor en medicina Markus Tolnay, operará como una de las localizaciones internacionales del NGS Companion Dx Center of Excellence Program dedicadas a la investigación y validación de la cartera de productos NGS de Oncomine de Thermo Fisher. "El Instituto de Genética Médica y Patología del Hospital Universitario de Basilea se enorgullece de colaborar con Thermo Fisher Scientific actuando como centro de excelencia durante este momento crucial en el que la investigación científica se encuentra a la puertas de, potencialmente, tener una influencia decisiva en la forma en la que el cáncer puede ser afrontado en el siglo XXI", dijo Tolnay. "Gracias a este acuerdo, estamos seguros de que juntos lograremos avanzar enormemente para acelerar la participación en ensayos clínicos y desarrollar soluciones innovadoras que beneficiarán a los hospitales y a los pacientes a los que tratan en el futuro". El Instituto de Genética Médica y Patología del Hospital Universitario de Basilea es uno de los principales centros de diagnóstico de Suiza –con miles de muestras que ya han sido procesadas utilizando NGS– y forma parte del Swiss Excellence Forum, un 'influenciador' estratégico de estrategia de diagnóstico y patología suiza. La estrecha colaboración entre el instituto, que pertenece a la universidad más antigua de Suiza, Thermo Fisher y un equipo multidisciplinario de patólogos, posibilitará descubrimientos e innovaciones que se beneficiarán del rico entorno de investigación farmacéutica y en ciencias de la vida de Basilea. La creciente cartera de pruebas de investigación oncológica basadas en NGS selectiva bajo la marca Oncomine de Thermo Fisher funcionará como la 'caja de herramientas' central a partir de la que el laboratorio de Tolnay y sus colaboradores llevarán a cabo actividades relativas al centro de excelencia en desarrollo de NGS y diagnóstico complementario. "La demanda de tecnologías novedosas que puedan un día reducir los tiempos de prueba y proporcionar respuestas exactas a oncólogos y pacientes está impulsando el desarrollo de soluciones basadas en NGS selectiva para fomentar una medicina de precisión", declaró Mark Stevenson, presidente de Soluciones de Ciencias de la Vida de Thermo Fisher Scientific. "Estamos comprometidos a ser el socio preferido del sector en esta labor y Thermo Fisher continuará forjando nuevas alianzas estratégicas con organizaciones internacionales líderes que comparten nuestra visión de un mundo más saludable". Acerca de Thermo Fisher Scientific Thermo Fisher Scientific Inc. es el líder mundial al servicio de la ciencia, con unos ingresos de 18 mil millones de dólares estadounidenses y más de 55.000 empleados a nivel internacional. Nuestra misión consiste en capacitar a nuestros clientes para que conviertan el mundo en un lugar más saludable, limpio y seguro. Ayudamos a nuestros clientes a acelerar la investigación en ciencias de la vida, resolver desafíos analíticos complejos, mejorar los diagnósticos de paciente y aumentar la productividad de los laboratorios. A través de nuestras marcas principales –Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific y Unity Lab Services– ofrecemos una inigualable combinación de tecnologías innovadoras, comodidad de compra y asistencia integral. Para obtener más información, visite www.thermofisher.com.


News Article | April 18, 2017
Site: www.prnewswire.com

CARLSBAD, California, 18 de abril de 2017 /PRNewswire/ -- Thermo Fisher Scientific ha firmado un acuerdo con el Instituto de Genética Médica y Patología del Hospital Universitario de Basilea, Suiza, para establecer a la distinguida institución como primer socio del Next Generation Sequencing Companion Dx Center of Excellence Program (Programa de centro de excelencia de secuenciación de próxima generación y diagnósticos complementarios), una nueva iniciativa diseñada para desarrollar y perfeccionar las pruebas de investigación basadas en NGS de su cartera oncológica Oncomine™ con el propósito de introducirlos eventualmente en la clínica como diagnósticos complementarios. Como parte del acuerdo, ambas organizaciones trabajarán conjuntamente para forjar alianzas internacionales y asociaciones estratégicas con grupos biofarmacéuticos y otros a fin de acelerar los ensayos en oncología e inmuno-oncología. Además, el Instituto de Genética Médica y Patología, gestionado por el doctor en medicina Markus Tolnay, operará como una de las localizaciones internacionales del NGS Companion Dx Center of Excellence Program dedicadas a la investigación y validación de la cartera de productos NGS de Oncomine de Thermo Fisher. "El Instituto de Genética Médica y Patología del Hospital Universitario de Basilea se enorgullece de colaborar con Thermo Fisher Scientific actuando como centro de excelencia durante este momento crucial en el que la investigación científica se encuentra a la puertas de, potencialmente, tener una influencia decisiva en la forma en la que el cáncer puede ser afrontado en el siglo XXI", dijo Tolnay. "Gracias a este acuerdo, estamos seguros de que juntos lograremos avanzar enormemente para acelerar la participación en ensayos clínicos y desarrollar soluciones innovadoras que beneficiarán a los hospitales y a los pacientes a los que tratan en el futuro". El Instituto de Genética Médica y Patología del Hospital Universitario de Basilea es uno de los principales centros de diagnóstico de Suiza –con miles de muestras que ya han sido procesadas utilizando NGS– y forma parte del Swiss Excellence Forum, un 'influenciador' estratégico de estrategia de diagnóstico y patología suiza. La estrecha colaboración entre el instituto, que pertenece a la universidad más antigua de Suiza, Thermo Fisher y un equipo multidisciplinario de patólogos, posibilitará descubrimientos e innovaciones que se beneficiarán del rico entorno de investigación farmacéutica y en ciencias de la vida de Basilea. La creciente cartera de pruebas de investigación oncológica basadas en NGS selectiva bajo la marca Oncomine de Thermo Fisher funcionará como la 'caja de herramientas' central a partir de la que el laboratorio de Tolnay y sus colaboradores llevarán a cabo actividades relativas al centro de excelencia en desarrollo de NGS y diagnóstico complementario. "La demanda de tecnologías novedosas que puedan un día reducir los tiempos de prueba y proporcionar respuestas exactas a oncólogos y pacientes está impulsando el desarrollo de soluciones basadas en NGS selectiva para fomentar una medicina de precisión", declaró Mark Stevenson, presidente de Soluciones de Ciencias de la Vida de Thermo Fisher Scientific. "Estamos comprometidos a ser el socio preferido del sector en esta labor y Thermo Fisher continuará forjando nuevas alianzas estratégicas con organizaciones internacionales líderes que comparten nuestra visión de un mundo más saludable". Acerca de Thermo Fisher Scientific Thermo Fisher Scientific Inc. es el líder mundial al servicio de la ciencia, con unos ingresos de 18 mil millones de dólares estadounidenses y más de 55.000 empleados a nivel internacional. Nuestra misión consiste en capacitar a nuestros clientes para que conviertan el mundo en un lugar más saludable, limpio y seguro. Ayudamos a nuestros clientes a acelerar la investigación en ciencias de la vida, resolver desafíos analíticos complejos, mejorar los diagnósticos de paciente y aumentar la productividad de los laboratorios. A través de nuestras marcas principales –Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific y Unity Lab Services– ofrecemos una inigualable combinación de tecnologías innovadoras, comodidad de compra y asistencia integral. Para obtener más información, visite www.thermofisher.com.


News Article | June 4, 2017
Site: www.sciencedaily.com

Breastfeeding after a caesarean section (C-section) may help manage pain, with mothers who breastfed their babies for at least 2 months after the operation three times less likely to experience persistent pain compared to those who breastfed for less than 2 months, according to new research being presented at this year's Euroanaesthesia Congress in Geneva (3-5 June). C-sections account for around a quarter of all births in the UK, USA, and Canada. Chronic pain (lasting for more than 3 months) after C-section affects around 1 in 5 mothers. It is widely accepted that breast milk is the most important and appropriate nutrition in early life, and WHO, the UK Department of Health, and US Department of Health and Human Services all recommend exclusive breastfeeding up to 6 months of age. But until now, little has been known about the effect of breastfeeding on a mother's experience of chronic pain after C-section. The study, by Dr Carmen Alicia Vargas Berenjeno and colleagues from the Hospital Universitario Nuestra Señora de Valme in Sevilla, Spain, included 185 mothers who underwent a C-section at the hospital between January 2015 and December 2016. Mothers were interviewed about breastfeeding patterns and the level of chronic pain at the surgical site in the first 24 and 72 hours after C-section, and again 4 months later. The researchers also looked at the effect of other variables on chronic pain including surgical technique, pain in the first 24-72 hours, maternal education and occupation, and anxiety during breastfeeding. Almost all (87%) of the mothers in the study breastfed their babies, with over half (58%) reporting breastfeeding for two months or longer. Findings showed that around 1 in 4 (23%) of the mothers who breastfed for two months or less still experienced chronic pain in the surgical site 4 months post-op compared to just 8% of those who breastfed for 2 months or longer. These differences were notable even after adjusting for the mother's age. Further analysis showed that mothers with a university education were much less likely to experience persistent pain compared to those who were less well educated. The researchers also found that over half (54%) of mothers who breastfed reported suffering from anxiety. The authors conclude: "These preliminary results suggest that breastfeeding for more than 2 months protects against chronic post-caesarean pain, with a three-fold increase in the risk of chronic pain if breastfeeding is only maintained for 2 months or less. Our study provides another good reason to encourage women to breastfeed. It's possible that anxiety during breastfeeding could influence the likelihood of pain at the surgical site 4 months after the operation." The authors are currently analysing additional data from women interviewed between November 2016 to January 2017, which, when combined with data from all the other women, shows that anxiety is associated with chronic post Caesarean pain in a statistically significant way.


The International Association of HealthCare Professionals is pleased to welcome Dr. Anna Falabella, MD, to their prestigious organization with her upcoming publication in The Leading Physicians of the World. She is a highly trained and qualified dermatologist, and is internationally known and respected for her passion and expertise in general dermatology, pediatric dermatology and the specialized area of wound healing. Dr. Falabella is currently serving patients as co-owner of Hollywood Dermatology & Cosmetic Specialists, with offices throughout South Florida. She maintains an appointment with the University of Miami/Jackson Memorial Hospital as a Voluntary Clinical Associate Professor of Dermatology and Cutaneous Surgery. Furthermore, Dr. Falabella holds clinical privileges with the Memorial Healthcare System, including Joe DiMaggio’s Children’s Hospital in Hollywood, Florida. Dr. Falabella’s accomplishments in clinical care and research are widely respected. Her career in medicine began in 1989 when she graduated with her Doctorate of Medicine and Surgery from the Universidad del Valle Sección de Medicina in Cali, Colombia, graduating as salutatorian. After completing an internship and Dermatology fellowship at the Hospital Universitario del Valle, she moved to New Orleans, Louisiana where she completed a three-year International Fellowship in Dermatology at Tulane University School of Medicine. In 1994, Dr. Falabella joined the University of Miami School of Medicine/Jackson Memorial Hospital in Miami, Florida, where she completed an internship in Internal Medicine, residency in Dermatology, and fellowship in Wound Healing in four years. She has earned the coveted title of Fellow of the American Board of Dermatology. Dr. Falabella maintains professional memberships with the Miami Society for Dermatology and Cutaneous Surgery, the Women Dermatological Society, the Wound Healing Society, the Florida Society of Dermatology, and the American Academy of Wound Management. She has served as a principal investigator or co-investigator in many research trials, and has authored or coauthored more than 60 articles, book chapters and abstracts. For her wealth of experience and knowledge, Dr. Falabella has been invited to give lectures at national meetings and world dermatologic congresses, and has received a number of prestigious awards including the Young Investigators Award from the American Academy of Dermatology. In 2002, she was one of 80 physicians who were named by the AAD as a Future Leader in Dermatology, and in 2003 the American Biographical Institute selected her as one of 2,000 Notable American Women. A strong advocate for community health and prevention, Dr. Falabella routinely volunteers at local health fairs, providing skin cancer screening to high-risk patients. In 2008, she successfully acquired a $10,000 grant from the American Academy of Dermatology to build a sunshade structure for Indian Trace Elementary School in Weston, FL, and in 2013 and 2015, she participated in 10-day medical mission trips to Peru with her medical staff. Dr. Falabella attributes her success to her love of Dermatology, passion for her work, and her dedication to providing the best possible care to her patients. When she is not working she enjoys cooking, reading and decorating. Learn more about Dr. Falabella here: https://www.hollywooddermatology.com/ and by reading her upcoming publication in The Leading Physicians of the World. FindaTopDoc.com is a hub for all things medicine, featuring detailed descriptions of medical professionals across all areas of expertise, and information on thousands of healthcare topics.  Each month, millions of patients use FindaTopDoc to find a doctor nearby and instantly book an appointment online or create a review.  FindaTopDoc.com features each doctor’s full professional biography highlighting their achievements, experience, patient reviews and areas of expertise.  A leading provider of valuable health information that helps empower patient and doctor alike, FindaTopDoc enables readers to live a happier and healthier life.  For more information about FindaTopDoc, visit: http://www.findatopdoc.com


News Article | June 3, 2017
Site: www.eurekalert.org

Breastfeeding after a caesarean section (C-section) may help manage pain, with mothers who breastfed their babies for at least 2 months after the operation three times less likely to experience persistent pain compared to those who breastfed for less than 2 months, according to new research being presented at this year's Euroanaesthesia Congress in Geneva (3-5 June). C-sections account for around a quarter of all births in the UK, USA, and Canada. Chronic pain (lasting for more than 3 months) after C-section affects around 1 in 5 mothers. It is widely accepted that breast milk is the most important and appropriate nutrition in early life, and WHO, the UK Department of Health, and US Department of Health and Human Services all recommend exclusive breastfeeding up to 6 months of age. But until now, little has been known about the effect of breastfeeding on a mother's experience of chronic pain after C-section. The study, by Dr Carmen Alicia Vargas Berenjeno and colleagues from the Hospital Universitario Nuestra Señora de Valme in Sevilla, Spain, included 185 mothers who underwent a C-section at the hospital between January 2015 and December 2016. Mothers were interviewed about breastfeeding patterns and the level of chronic pain at the surgical site in the first 24 and 72 hours after C-section, and again 4 months later. The researchers also looked at the effect of other variables on chronic pain including surgical technique, pain in the first 24-72 hours, maternal education and occupation, and anxiety during breastfeeding. Almost all (87%) of the mothers in the study breastfed their babies, with over half (58%) reporting breastfeeding for two months or longer. Findings showed that around 1 in 4 (23%) of the mothers who breastfed for two months or less still experienced chronic pain in the surgical site 4 months post-op compared to just 8% of those who breastfed for 2 months or longer. These differences were notable even after adjusting for the mother's age. Further analysis showed that mothers with a university education were much less likely to experience persistent pain compared to those who were less well educated. The researchers also found that over half (54%) of mothers who breastfed reported suffering from anxiety. The authors conclude: "These preliminary results suggest that breastfeeding for more than 2 months protects against chronic post-caesarean pain, with a three-fold increase in the risk of chronic pain if breastfeeding is only maintained for 2 months or less. Our study provides another good reason to encourage women to breastfeed. It's possible that anxiety during breastfeeding could influence the likelihood of pain at the surgical site 4 months after the operation." The authors are currently analysing additional data from women interviewed between November 2016 to January 2017, which, when combined with data from all the other women, shows that anxiety is associated with chronic post Caesarean pain in a statistically significant way.


A lo largo de los años, la PSMF ha asumido un creciente alcance internacional para alcanzar cero muertes evitables de pacientes para 2020. Actualmente cuenta con más de 30 sedes regionales en todo el mundo y alianzas con organizaciones globales, como la Federación Mundial de Sociedades de Anestesiólogos (World Federation of Societies of Anaesthesiologists, WFSA), la Sociedad Europea de Anestesiología (European Society of Anesthesiology, ESA), la Alianza Mundial contra la Sepsis (Global Sepsis Alliance, GSA), el Club de Cultura de Seguridad del Paciente de Taiwán (Taiwan Patient Safety Culture Club, TPSCC), el Sistema Español de Notificación en Seguridad en Anestesia y Reanimación (SENSAR), el Hospital Universitario de Edna Adan (Edna Adan University Hospital) y el Centro de Cáncer A.C.Camargo (AC Camargo Cancer Center). Aproximadamente 1000 hospitales fuera de los Estados Unidos están representados en los compromisos para erradicar muertes evitables de pacientes. La cumbre anual de la PSMF reúne a líderes de comunidades hospitalarias, de atención médica, de tecnología, de política pública y de defensa de los pacientes de todo el mundo, a fin de analizar soluciones para abordar las principales causas de muertes evitables de pacientes en hospitales.


WILMINGTON, Del. & MADRID--(BUSINESS WIRE)--AstraZeneca and MedImmune, its global biologics research and development arm, today announced the full progression-free survival (PFS) data from a planned interim analysis of the investigational Phase III PACIFIC trial. Results show that IMFINZI® (durvalumab) demonstrated a statistically-significant and clinically-meaningful improvement in PFS compared to current standard of care with active surveillance in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT). Results of the trial, included in the Presidential Symposium I of the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, show an improvement in PFS of more than 11 months in patients treated with durvalumab compared to placebo (HR 0.52; 95% CI, 0.42-0.65; p<0.0001) (see full details below). The PFS improvement with durvalumab was observed across all pre-specified subgroups, including PD-L1 expression status (assessed at time of diagnosis). Patients receiving IMFINZI also had a lower incidence of metastases than those receiving placebo. The PACIFIC trial continues to evaluate overall survival (OS), the other primary endpoint. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The Phase III PACIFIC results are incredibly encouraging for a patient population that until now has been without treatment options. As the first Immuno-Oncology medicine to achieve improvement in progression-free survival in this setting, IMFINZI is showing clear potential to become the new standard of care for patients with locally advanced, unresectable NSCLC who have not progressed following chemoradiation.” Dr. Luis Paz-Ares, Principal Investigator of the PACIFIC trial, from the Hospital Universitario Doce de Octubre in Madrid, Spain, said: “For patients with locally advanced, unresectable NSCLC who have completed chemoradiation therapy, IMFINZI represents a potential new treatment option in the context of clear unmet clinical need. Durvalumab overtly prolongs the period in which the disease is controlled with reasonable side effects. In addition, it offers hope to increase the cure rate in this setting, but more mature follow-up is needed to assess its impact on survival.” * Time from randomization to the first documented tumor progression or death in the absence of progression. Randomization in the PACIFIC trial occurred up to 6 weeks after concurrent chemoradiation therapy (cCRT) and cCRT typically lasted at least 6 weeks. ** Assessed in patients with measurable disease at baseline. Among patients receiving durvalumab, the most frequent adverse events (AEs) vs placebo were cough (35.4% vs 25.2%), pneumonitis/radiation pneumonitis (33.9% vs 24.8%), fatigue (23.8% vs 20.5%), dyspnea (22.3% vs 23.9%) and diarrhea (18.3% vs 18.8%). 29.9% of patients experienced a grade 3 or 4 AE vs 26.1% for placebo, and 15.4% of patients discontinued treatment due to AEs, compared to 9.8% of patients on placebo. See below for additional important safety information for IMFINZI. On July 31, 2017, durvalumab received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) as a potential treatment for patients with locally advanced, unresectable NSCLC whose disease had not progressed following platinum-based chemoradiation therapy. This indication is not FDA-approved. AstraZeneca is in discussions with global health authorities regarding regulatory submissions for durvalumab based on the PACIFIC data. A status of regulatory submissions is usually provided with the Company’s quarterly results announcement. In May 2017, AstraZeneca received accelerated approval from the FDA for IMFINZI for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. IMFINZI is approved under the FDA’s accelerated approval pathway, based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. There are no contraindications for IMFINZI® (durvalumab). Monitor patients for clinical signs and symptoms of immune-mediated pneumonitis, hepatitis, colitis or diarrhea, endocrinopathies, nephritis, rash or dermatitis, other immune-mediated adverse reactions, and infection. Please refer to the full Prescribing Information for important dose management information specific to adverse reactions. In the combined safety database (n=1414), immune-mediated pneumonitis occurred in 32 patients (2.3%), including 1 fatal case (0.1%) and 6 Grade 3–4 cases (0.4%). In Study 1 (n=182), 1 patient (0.5%) died from immune-mediated pneumonitis. Monitor patients for signs and symptoms of pneumonitis and evaluate with radiographic imaging when suspected. Administer corticosteroids for ≥Grade 2 pneumonitis. Withhold IMFINZI for Grade 2 pneumonitis; permanently discontinue for Grade 3–4 pneumonitis. In the combined safety database (n=1414), immune-mediated hepatitis occurred in 16 patients (1.1%), including 1 fatal case (<0.1%) and 9 Grade 3 cases (0.6%). Grade 3–4 elevations in ALT occurred in 40/1342 patients (3.0%), AST in 58/1336 patients (4.3%), and total bilirubin in 37/1341 patients (2.8%). In Study 1 (n=182), 1 patient (0.5%) died from immune-mediated hepatitis, and 2 patients (1.1%) experienced immune-mediated hepatitis, including 1 Grade 3 case (0.5%). Monitor patients for abnormal liver tests in each cycle during treatment with IMFINZI. Administer corticosteroids and withhold IMFINZI for Grade 2–3 ALT or AST >3–5X ULN or ≤8X ULN or total bilirubin >1.5–3X ULN or ≤5X ULN. Permanently discontinue IMFINZI in patients with Grade 3 ALT or AST >8X ULN or total bilirubin >5X ULN, or in patients with concurrent ALT or AST >3X ULN and total bilirubin >2X ULN with no other cause. In the combined safety database (n=1414), immune-mediated colitis or diarrhea occurred in 18 patients (1.3%), including 1 Grade 4 case (<0.1%) and 4 Grade 3 cases (0.3%). In Study 1 (n=182), 23 patients (12.6%) experienced colitis or diarrhea, including 2 Grade 3–4 cases (1.1%). Monitor patients for signs and symptoms of colitis or diarrhea. Administer corticosteroids for ≥Grade 2 colitis or diarrhea. Withhold IMFINZI for Grade 2 colitis or diarrhea; permanently discontinue for Grade 3–4 colitis or diarrhea. Severe infections, including sepsis, necrotizing fasciitis, and osteomyelitis, occurred in patients receiving IMFINZI. In the combined safety database (n=1414), infections occurred in 531 patients (37.6%). In Study 1 (n=182), infections occurred in 54 patients (29.7%). 11 patients (6.0%) experienced Grade 3–4 infection and 5 patients (2.7%) were experiencing infection at the time of death. 8 patients (4.4%) experienced urinary tract infection, the most common ≥Grade 3 infection. Monitor patients for signs and symptoms of infection and treat with anti-infectives for suspected or confirmed infections. Withhold IMFINZI for ≥Grade 3 infection. In the combined safety database (n=1414), severe infusion-related reactions occurred in 26 patients (1.8%). In Study 1 (n=182), infusion-related reactions occurred in 3 patients (1.6%). There were 5 Grade 3 (0.4%) and no Grade 4 or 5 reactions. Patients should be monitored for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1–2 infusion-related reactions and permanently discontinue for Grade 3–4 infusion-related reactions. Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. There are no data on the use of IMFINZI in pregnant women. Advise pregnant women of the potential risk to a fetus and advise women of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of IMFINZI. There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for adverse reactions in breastfed infants from IMFINZI, advise a lactating woman not to breastfeed during treatment and for at least 3 months after the last dose. The safety and effectiveness of IMFINZI have not been established in pediatric patients. The PACIFIC trial is a randomized, double-blinded, placebo-controlled multi-center trial of durvalumab as sequential treatment in unselected patients with locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemotherapy concurrent with radiation therapy. The trial is being conducted in 235 centers across 26 countries, involving approximately 700 patients. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS), and secondary endpoints include landmark PFS and OS, objective response rate and duration of response. IMFINZI® (durvalumab) is a human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80. Durvalumab continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in Immuno-Oncology. Durvalumab is being assessed in Phase III trials as a monotherapy in various stages of non-small cell lung cancer (NSCLC), in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of durvalumab and tremelimumab is being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular carcinoma and hematological malignancies. Stage III lung cancer is divided into three sub-categories (IIIA, IIIB and IIIC), which are defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from Stage IV disease, when the cancer has metastasized to other organs. Stage III lung cancer represents approximately one-third of non-small cell lung cancer incidence and is estimated to affect over 43,000 patients in the United States. About half of these patients have tumors that are unresectable. The current standard of care is chemotherapy and radiation followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low. AstraZeneca is committed to developing therapies to help every patient with lung cancer. We have two approved therapies and a growing pipeline that targets genetic changes in tumor cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy. Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumors. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumor immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients. We are pursuing a comprehensive clinical trial program that includes durvalumab (anti-PD-L1 antibody) monotherapy and in combination with tremelimumab (anti-CTLA-4 antibody) in multiple tumor types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumors. AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in hematology. By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death. MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, MD, one of AstraZeneca’s three global R&D centers, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit www.medimmune.com. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.


Cambridge, UK, 12-Sep-2017 — /EuropaWire/ — AstraZeneca and MedImmune, its global biologics research and development arm, have presented the full PFS data from a planned interim analysis of the Phase III PACIFIC trial. Results show that Imfinzi (durvalumab) demonstrated a statistically-significant and clinically-meaningful improvement in PFS compared to current standard of care with active surveillance in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT). Results of the Phase III PACIFIC trial, included at the Presidential Symposium I of the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, show an improvement in PFS of more than 11 months in patients treated with Imfinzi compared to placebo (full details in table below). The PFS improvement with Imfinzi was observed across all pre-specified subgroups, including PD-L1 expression status. Patients receiving Imfinzi also had a lower incidence of metastases than those receiving placebo. The PACIFIC trial continues to evaluate overall survival (OS), the other primary endpoint. Detailed results of the PACIFIC trial are published online in the New England Journal of Medicine. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The Phase III PACIFIC results are incredibly encouraging for a patient population that until now has been without treatment options. As the first Immuno-Oncology medicine to achieve improvement in progression-free survival in this setting, Imfinzi is showing clear potential to become a new standard of care for patients with locally-advanced, unresectable NSCLC who have not progressed following chemoradiation.” Dr. Luis Paz-Ares, Principal Investigator of the PACIFIC trial, from the Hospital Universitario Doce de Octubre, Madrid, Spain, said: “For patients with locally-advanced unresectable NSCLC who have completed chemoradiation therapy, Imfinzi represents a potential new treatment option in the context of clear unmet clinical need. Durvalumab overtly prolongs the period in which the disease is controlled with reasonable side effects. In addition, it offers hope to increase the cure rate in this setting, but more mature follow-up is needed to assess its impact on survival.” Among patients receiving Imfinzi, the most frequent treatment-related adverse events (AEs) vs. placebo were cough (35.4% vs 25.2%), pneumonitis/radiation pneumonitis (33.9% vs 24.8%), fatigue (23.8% vs 20.5%), dyspnoea (22.3% vs 23.9%) and diarrhoea (18.3% vs 18.8%). 29.9% of patients experienced a grade 3 or 4 AE vs. 26.1% for placebo, and 15.4% of patients discontinued treatment due to AEs compared to 9.8% of patients on placebo. On 31 July 2017, Imfinzi received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) as a potential treatment for patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. AstraZeneca is in discussions with global health authorities regarding regulatory submissions for Imfinzi based on the PACIFIC data. A status of regulatory submissions is usually provided with the Company’s quarterly results announcement. Imfinzi received accelerated approval from the US Food and Drug Administration for previously treated patients with advanced bladder cancer and is under review in Canada and Australia for similar use. About Locally Advanced (Stage III) NSCLC Stage III lung cancer is divided into two stages (IIIA and IIIB), which are defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from Stage IV disease, when the cancer has spread (metastasised) to other organs. Stage III lung cancer represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the G7 countries in 2016. More than half of these patients have tumours that are unresectable. The current standard of care is chemotherapy and radiation followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low. About PACIFIC The PACIFIC trial is a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as sequential treatment in unselected patients with locally-advanced, unresectable (Stage III) NSCLC who have not progressed following platinum-based chemotherapy concurrent with radiation therapy. The trial is being conducted in 235 centres across 26 countries involving approximately 700 patients. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS), and secondary endpoints include landmark PFS and OS, objective response rate (ORR) and duration of response. About Imfinzi Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour’s immune-evading tactics and inducing an immune response. Imfinzi continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in Immuno-Oncology. Imfinzi is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular carcinoma and haematological malignancies. About AstraZeneca in Lung Cancer AstraZeneca is committed to developing therapies to help every patient with lung cancer. We have two approved therapies and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy. About AstraZeneca’s Approach to Immuno-Oncology (IO) Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients. We are pursuing a comprehensive clinical trial programme that includes Imfinzi (anti-PD-L1) monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours. About AstraZeneca in Oncology AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology. By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody-Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death. About MedImmune MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit www.medimmune.com. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.


News Article | February 24, 2017
Site: www.eurekalert.org

Orlando- In a significant advance in improving the safety of donor stem cell transplants, a major clinical trial led by researchers at Dana-Farber Cancer Institute and Brigham and Women's Hospital (BWH) has shown that a novel agent can protect against the most common viral infection that patients face after transplantation. The results represent a breakthrough in a decade-long effort to identify an effective drug for the prevention of CMV infection in transplant patients that doesn't produce side effects that negate the benefit of the drug itself, the study authors said. The findings, from an international phase 3 clinical trial of the drug letermovir for preventing cytomegalovirus (CMV) infection in transplant patients, will be presented at the 2017 Bone Marrow Transplant Tandem Meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) in Orlando, Florida, February 22, 2017. The study, which involved 565 adult patients at 67 research centers in 20 countries, compared letermovir to placebo in preventing an active CMV infection following transplant with donor stem cells. The patients, who were undergoing transplant as treatment for blood-related cancers or other disorders, all carried a CMV infection from earlier in life that had been wrestled into dormancy by their immune system. Twenty-four weeks after completing up to 14 weeks of treatment, 61 percent of the patients receiving a placebo had developed a CMV infection serious enough to require treatment or had discontinued the trial. By contrast, only 38 percent of those treated with letermovir developed that level of CMV infection or did not complete the trial. Unlike other drugs able to forestall active CMV infection in stem cell transplant patients, letermovir did so without producing unacceptable toxicities. Most of the side effects associated with letermovir were tolerable, including mild cases of nausea or vomiting, and some swelling, investigators found. Letermovir also conferred a survival benefit: at the 24-week mark, 15 percent of the placebo patients had died, compared to 10 percent of those receiving letermovir. "For the first time, we seem to have a drug that is a true safe and effective preventive for CMV infection in stem cell transplant patients," said the study's lead author, Francisco Marty, MD, an infectious disease specialist at Dana-Farber and BWH. "Letermovir will allow many patients to avoid infection, usually with no or mild side effects, and seems to provide a survival benefit in the first six months post-transplant." Transplantation of donor hematopoietic stem cells - which give rise to all types of blood cells, including white blood cells of the immune system - is used to treat blood-related cancers such as leukemia, lymphoma, and myeloma, as well as several types of non-cancerous blood disorders. Patients typically receive chemotherapy to wipe out or reduce the bone marrow, where blood cells are formed, followed by an infusion of donor stem cells to rebuild their blood supply and reconstitute their immune system. While refinements in transplant techniques have sharply improved the safety of the procedure, the reactivation of CMV infection following a transplant has been a longstanding problem. Infection with CMV, a type of herpes virus, is one of the most common viral infections in the world. In the United States, it's estimated that over 50 percent of people are infected before adulthood. In other parts of the world, infection rates can be significantly higher. The effects of CMV infection can range from no symptoms to a flu-like fever or mononucleosis ("mono") syndrome. Once the immune system has brought the infection under control, the virus persists unobtrusively in the body. The jolt of a stem cell transplant - the rapid erasure or diminishment of the immune system produced by pre-transplant chemotherapy, as well as measures to prevent graft-versus-host disease - can give CMV a chance to reawaken and run amok before the newly reconstituted immune system takes hold. In the early years of bone marrow transplant therapy, 60 to 70 percent of transplant recipients developed CMV infection, Marty recounts. Of those, 20 to 30 percent contracted CMV pneumonia, and of those, 80 percent died of the disease. In previous clinical trials, several drugs aimed at preventing CMV infection in stem cell transplant patients either were not effective or produced intolerable side effects. In the absence of safe preventive drugs, physicians worked out a "surveillance" approach in which they provide treatment only when patients develop CMV infection, and only for a short period of time. This strategy has largely been a success: patients now have just a 2 or 3 percent chance of getting CMV disease affecting the lungs or other organs. Still, the often harsh side effects of current drugs were reason to continue the search for a useful preventive agent. Letermovir works by a different mechanism from previously tested agents, which block an enzyme known as DNA polymerase, which viruses use to duplicate their DNA. (Human cells use the same process to replicate their own DNA.) By contrast, letermovir blocks a process by which CMV is "packaged" inside infected cells - a wrapping that allows it to go on and infect other cells. The fact that this process does not occur in human cells may explain in part why letermovir usually gives rise to only mild side effects, researchers say. In the trial, patients received letermovir or a placebo beginning an average of nine days after transplant. "The goal was to suppress the virus before it has a chance to become active," Marty remarked. "The results of this trial offer encouragement that letermovir can offer a new strategy for donor stem cell transplant patients in preventing the emergence of CMV infection following transplant." The senior author of the study is Cyrus Badshah, MD, PhD, of Merck & Co., the developer of letermovir. Co-authors are Per T. Ljungman, MD, PhD, of Karolinska University Hospital, Stockholm, Sweden; Roy F. Chemaly, MD, MPH, of MD Anderson Cancer Center; Johan A. Maertens, MD, PhD, of Universitaire Ziekenhuizen, Leuven, Belgium; David R. Snydman, MD, of Tufts Medical Center; Rafael F. Duarte, MD, PhD, of Hospital Universitario Puerta de Hierro, Madrid, Spain; Emily A. Blumberg, MD, of the University of Pennsylvania; Hermann Einsele, MD, of Universitätsklinikum Würzburg, Würzburg, Germany; Michael J. Boeckh, MD, of Fred Hutchinson Cancer Research Center; and Valerie L. Teal, MS, Hong Wan, PhD, Nicholas A. Kartsonis, MD, and Randi Y. Leavitt, MD, PhD, of Merck & Co.


News Article | February 15, 2017
Site: www.prnewswire.co.uk

Strekin AG, una compañía biofarmacéutica de propiedad privada y en fase clínica, anunció hoy la presentación de los nuevos datos preclínicos y la actualización del programa de desarrollo clínico en fase 2 de Strekin para STR001 en el tratamiento de la pérdida auditiva durante la celebración de la Association for Research in Otolaryngology Conference (ARO) en Baltimore, Estados Unidos. STR001-201 es un ensayo clínico en fase 2 de la inyección intra-timpánica STR001 para el tratamiento de la pérdida auditiva repentina sensorineural (SSHL) causada por la cirugía de implantación coclear (CI). Un resultado no deseado de CI es la pérdida de audición residual de baja frecuencia debido a la inserción de electrodos. STR001-201 es un ensayo internacional, multicentro, aleatorio y controlado por placebo que evaluó la eficacia, seguridad y tolerabilidad de STR001-IT en 110 pacientes con CI. A fecha de 10 de febrero de 2017, el ensayo STR001-201 había reclutado a 50 pacientes en cuatro países. El tratamiento con STR001-IT se había tolerado correctamente y sin efectos secundarios preocupantes identificados. Los resultados de los ensayos clínicos de primera línea se esperan para el cuarto trimestre de 2017. En una presentación poster (#PS792) titulada "Peroxisome proliferator activated receptor -gamma and -alpha agonists protect auditory hair cells from gentamicin-induced oxidative stress and apoptosis", los investigadores han observado que la pioglitazona agonista PPAR, ingrediente activo de STR001, fue altamente eficaz en la prevención de los daños de las células sensoriales del pelo del interior de la oreja. La investigación la dirigió Daniel Bodmer, doctor, PhD y presidente del Department of Otolaryngology Head & Neck Surgery del Hospital Universitario de Basilea, Suiza. El análisis del doctor Bodmer lo llevó a cabo en un modelo de investigación de audición en el que el órgano de Corti, la estructura que contiene el pelo auditorio y células sensoriales, se estudió dentro del cultivo del tejido. El tratamiento de los cultivos con gentamicina, un antibiótico que lleva a la pérdida de audición en los humanos, causó una pérdida de células de pelo que era casi completamente prevenible con STR001. Un análisis posterior demostró que los radicales sin oxígeno inducidos por gentamicina promueven la oxidación de los lípidos y activan la ruta de muerte celular (apoptosis) en las células de los pelos, todo ello prevenible con STR001. En una segunda presentación (PS159) titulada "Intra-tympanic Administration of Pioglitazone, a Peroxisome Proliferator-Activated Receptor Gamma Agonist, Protects from Noise-Induced Hearing Loss", la doctora Anna-Rita Fetoni y sus colegas de la Universidad Católica de Roma, demostraron que una única inyección intra-timpánica de STR001-IT fue altamente eficaz en un modelo de roedor con pérdida de audición inducida por ruido. STR001 promovió la recuperación completa de audición cuando se le suministró justo después del ruido. La recuperación estuvo acompañada de una reducción destacada en los marcadores de estrés de oxidación en las células de pelos de audición. El tratamiento retrasado con STR001 hasta 48 horas después del ruido promocionó una recuperación parcial, que por lo que sabemos, no se ha demostrado en otros fármacos. Estos datos, junto a los datos del grupo del doctor Bodmer, sugieren que STR001 cuenta con potencial para ser una terapia nueva y diferente de muchos tipos de pérdida auditiva a través de los efectos favorables en múltiples rutas. Strekin es una compañía de ciencias de la vida en fase clínica de propiedad privada localizada en Basilea, Suiza. Strekin está dirigida por un equipo experimentado con un fuerte historial en investigación y desarrollo clínico. Strekin está financiada suficientemente para completar el estudio de fase 2 de STR001 y preparar otros desarrollos clínicos con el apoyo de inversores o socios. Según la Organización Mundial de la Salud, 642 millones de personas de todo el mundo, incluyendo 181 millones de niños, sufren hoy de pérdida auditiva discapacitadora. Las actividades diarias que la mayoría de las personas dan por hecho, como tener una conversación, escuchar música y avanzar en el espacio de trabajo, son difíciles o imposibles para las personas que padecen pérdida auditiva. Sin terapias farmacéuticas aprobadas disponibles hoy, hay una renovada urgencia por desarrollar tratamientos efectivos para la pérdida auditiva.

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