SOURCE Society for the Study of Reproduction
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Showing posts with label study. Show all posts
Showing posts with label study. Show all posts
Largest International Meeting for the Study of Reproductive Biology Attracts Researchers from 36 Countries in Grand Rapids, Michigan
OptiScan Biomedical Enrolls First Patient in Pivotal U.S. Clinical Study of OptiScanner® 5000
HAYWARD, Calif., April 28, 2014 /PRNewswire/ -- OptiScan Biomedical Corporation, a developer of innovative continuous monitoring systems for use in the intensive care unit (ICU), today announced the enrollment of the first patient in a pivotal, multi-center Investigational Device Exemption (IDE) clinical study of the OptiScanner® 5000. The OptiScanner 5000 is the company's first-of-its-kind automated, bedside glucose monitoring system that provides physicians with critical information to manage patient glucose levels in the ICU. The pivotal trial, known as the MANAGE IDE Study (Manual vs. Automated moNitoring Accuracy of GlucosE IDE), is expected to enroll 200 patients at up to 10 sites, most of which will be located in the U.S. The study's initial three clinical sites include: Washington University School of Medicine in St. Louis, MO; Tufts University School of Medicine in Boston, MA; and Saint Luke's Mid-America Heart Institute in Kansas City, MO. If successful, the MANAGE IDE study will serve as the basis for an application for approval in the U.S.The OptiScanner 5000 represents a significant advancement in the delivery of care to ICU patients by automating the measurement of patients' plasma glucose, as opposed to current manual measurement of glucose in whole blood. It is estimated that approximately 20 percent of ICU patients have pre-existing diabetes and an additional 40 to 60 percent of ICU patients suffer from "stress hyperglycemia" or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control. "The initiation of this pivotal study of the OptiScanner 5000 represents a key milestone for OptiScan as we continue our efforts to bring the paradigm-shifting potential of this platform to critically ill patients and those ICU physicians responsible for their care," said Peter Rule, chairman and chief executive officer of OptiScan Biomedical. "There is an acute need for breakthrough technologies that enable the automated, real-time monitoring of blood glucose in ICU patients in order to combat both the hyperglycemia and hypoglycemia that further complicate their already challenging health conditions. Our extensive clinical research to date demonstrates the OptiScanner 5000's ability to safely and effectively meet these needs and we are eager to see the MANAGE IDE trial further corroborate those findings." This pivotal MANAGE IDE study follows OptiScan's previously completed MANAGE I and MANAGE II trials, which were conducted at two world class European research centers and evaluated the OptiScanner 5000 in very sick ICU patients. Taken together, these studies represent the most comprehensive clinical validation program conducted to date with a continuous blood monitoring platform in the critical care setting. Results from these studies demonstrated the ability of the OptiScanner 5000 to combine accurate blood glucose measurement with the convenience of continuous, real-time bedside monitoring.Based on previous studies, the OptiScanner 5000 has received CE Mark certification for use in the European Union, allowing it to be sold and marketed in the 30 countries that make up the European Economic Area (EEA). OptiScan has initiated commercial efforts in the EU in 2014.About the OptiScanner® 5000The OptiScanner® 5000 is a first-of-its-kind automated, bedside glucose monitoring system that provides physicians with information on glucose levels in the ICU. Through automated monitoring of a patient's glucose values in plasma (as opposed to whole blood), the OptiScanner has alarms to alert clinicians to the existence of hyperglycemia (values that are too high) and hypoglycemia (values that are too low). It is estimated that between 60-80% of all ICU patients suffer from elevated glucose values, requiring insulin delivery and frequent glucose monitoring. About OptiScan BiomedicalOptiScan Biomedical is the world leader in developing innovative continuous monitoring systems for use in hospital intensive care units (ICU). The company has developed the OptiScanner® 5000, a first-of-its-kind automated, bedside glucose monitoring system that provides accurate, automated monitoring of patients' glucose levels measured in plasma, as opposed to whole blood. The system prominently displays glucose level trend data updated every 15 minutes to help manage patients' glucose levels within an optimum target range. The company is currently developing a next-generation OptiScanner product. The OptiScanner 6000 will expand the glucose monitoring capability of the platform technology to include monitoring of two leading measures of cardiac output and oxygenation (hemoglobin and ScvO2) in the same single blood sample, thereby providing additional information about the condition of a critically ill patient.For more information visit: www.optiscancorp.comVida Strategic Partners (On behalf of OptiScan)Patrick Nugent, Chief Financial Officer
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SOURCE OptiScan Biomedical Corporation
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AbbVie Announces Initiation of Pivotal Phase III Study of Veliparib (ABT-888) for Patients with Non-Small Cell Lung Cancer
NORTH CHICAGO, Ill., April 15, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the initiation of a global Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). The trial will compare patients randomized to receive either the standard chemotherapies of carboplatin and paclitaxel with the addition of veliparib, versus patients receiving carboplatin and paclitaxel with the addition of placebo. "Lung cancer is one of most common cancers worldwide and can be difficult to treat, particularly when it is diagnosed in the more advanced stages of the disease," said Scott Brun M.D., vice president, Pharmaceutical Development, AbbVie. "This Phase III trial is an important step in the development of veliparib and in potentially providing patients with squamous non-small cell lung cancer with a new treatment option."This randomized, placebo-controlled, double-blind, multicenter, Phase III trial will recruit approximately 900 patients. The primary efficacy outcome of the trial is overall survival (OS). Other pre-specified outcome measures include progression-free survival (PFS), and objective response rate (ORR). The safety of veliparib will also be evaluated in the trial.More information on the trial is available at www.clinicaltrials.gov (NCT02106546). About Veliparib (ABT-888)
Veliparib (ABT-888) is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally occurring enzyme in the body that repairs damage to DNA, and contributes to chemotherapy resistance in cancer cells. Discovered and developed by AbbVie researchers, veliparib is being developed to increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in more than a dozen cancers and tumor types, including breast, ovarian, and non-small cell lung cancers. About Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85-to-90 percent of diagnosed cases.i There are three common subtypes of NSCLC: adenocarcinoma, squamous cell (epidermoid) carcinoma, and large cell (undifferentiated) carcinoma. Adenocarcinoma accounts for approximately 40 percent of lung cancers and is the most common form of NSCLC in patients who smoke, have smoked or have never smoked. Adenocarcinoma typically originates in the outer parts of the lung. Squamous cell carcinoma accounts for about 25-to-30 percent of NSCLC cases, and is usually found in the middle airways of the lungs. Squamous cell is often linked to patients with a history of smoking. About 10-to-15 percent of NSCLC cases are considered large cell carcinomas, which tend to grow and spread quickly, making it a more difficult-to-treat form of NSCLC. Other subtypes exist, but are less common.iiLung cancer (both small cell and non-small cell) is the second most common cancer in both men and women. It accounts for about 13 percent of all new cancers in the U.S. and is the leading cause of cancer-related death among both men and women, causing more deaths than colon, breast, and prostate cancers combined.iii Worldwide, it is the most common form of cancer.iv Once NSCLC is diagnosed, treatment options can include surgery, radiation therapy, chemotherapy or targeted therapies, depending on the stage of the disease.vAbout AbbVie Oncology
The fight against cancer is one of the greatest battles in medicine and the varied nature of the disease requires a diverse approach that looks at multiple disease targets in a variety of tumor types. AbbVie's oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. Our oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types. About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.i "Non-Small Cell Lung Cancer." The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/index?sitearea ii "Non-Small Cell Lung Cancer: Detailed Guide." The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/index iii "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics iv "Lung Cancer Incidence Statistics." Cancer Research U.K., Accessed March 12, 2014: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/lung/incidence/uk-lung-cancer-incidence-statistics#geog v "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-treating-general-info
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Veliparib (ABT-888) is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally occurring enzyme in the body that repairs damage to DNA, and contributes to chemotherapy resistance in cancer cells. Discovered and developed by AbbVie researchers, veliparib is being developed to increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in more than a dozen cancers and tumor types, including breast, ovarian, and non-small cell lung cancers. About Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85-to-90 percent of diagnosed cases.i There are three common subtypes of NSCLC: adenocarcinoma, squamous cell (epidermoid) carcinoma, and large cell (undifferentiated) carcinoma. Adenocarcinoma accounts for approximately 40 percent of lung cancers and is the most common form of NSCLC in patients who smoke, have smoked or have never smoked. Adenocarcinoma typically originates in the outer parts of the lung. Squamous cell carcinoma accounts for about 25-to-30 percent of NSCLC cases, and is usually found in the middle airways of the lungs. Squamous cell is often linked to patients with a history of smoking. About 10-to-15 percent of NSCLC cases are considered large cell carcinomas, which tend to grow and spread quickly, making it a more difficult-to-treat form of NSCLC. Other subtypes exist, but are less common.iiLung cancer (both small cell and non-small cell) is the second most common cancer in both men and women. It accounts for about 13 percent of all new cancers in the U.S. and is the leading cause of cancer-related death among both men and women, causing more deaths than colon, breast, and prostate cancers combined.iii Worldwide, it is the most common form of cancer.iv Once NSCLC is diagnosed, treatment options can include surgery, radiation therapy, chemotherapy or targeted therapies, depending on the stage of the disease.vAbout AbbVie Oncology
The fight against cancer is one of the greatest battles in medicine and the varied nature of the disease requires a diverse approach that looks at multiple disease targets in a variety of tumor types. AbbVie's oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. Our oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types. About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.i "Non-Small Cell Lung Cancer." The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/index?sitearea ii "Non-Small Cell Lung Cancer: Detailed Guide." The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/index iii "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics iv "Lung Cancer Incidence Statistics." Cancer Research U.K., Accessed March 12, 2014: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/lung/incidence/uk-lung-cancer-incidence-statistics#geog v "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-treating-general-info
SOURCE AbbVie
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ZIO ® service identifies arrhythmias significantly more than the traditional Holter Monitor, according to study published online in the American Journal of medicine
SAN FRANCISCO, 02 January 2014/PRNewswire /-iRhythm Technologies, a company of services of health information, today announced that a prospective study from the Scripps Translational Science Institute (STSI) has found that the use of the service of the company ZIO significantly increased detection of cardiac arrhythmias, compared to the use of the traditional Holter monitor. Findings, published and made publicly accessible online in the January issue of the American Journal of Medicine, underscore the role of the service ZIO, ZIO, patented algorithms patch and ZIO review, as the new standard for the ambulatory monitoring of patients with suspected arrhythmia.
Service ZIO, ZIO, patented algorithms patch and ZIO report, is recognized more and more as the new standard for patients with suspected arrhythmia ambulatory cardiac monitoring. ZIO patch is a non-invasive, resistant to water, which is easy to use and discreet to wear, high compliance of the patient and a higher diagnostic yield. Proprietary algorithms analyze the data hit captured heart and provides a concise report to the patient's physician. Since its commercial launch in 2011, has been ZIO service with more than 200,000 patients in nearly 800 institutions throughout the country. ZIO is covered by most Medicare patients and main payers private throughout the country, representing more than 150 million of lives covered.
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"This is the first large prospective validation that this new technology passed the device invented by Norman Holter in 1949," said the lead author of the study, Dr. Eric Topol, a cardiologist who directs STSI and serves as the academic director of Scripps Health. "By tracking every beat of the heart up to two weeks, ZIO service proved to be significantly more sensitive than the Holter standard, it uses multiple threads and it is normally only used or tolerated during 24 hours.
"For" millions of people who presented each year with suspected arrhythmia, this could to be the new standard for the capture of the electric guilty heart rhythm disturbance, most commonly atrial fibrillation that carries a significant risk of race, he said.The prospective study included 146 consecutive patients of Scripps Health who were referred for evaluation of cardiac arrhythmias and underwent an outpatient monitoring simultaneous ECG with ZIO patch, a patch on the chest, which continuously monitor the heartbeat records up to 14 days and a conventional 24-hour Holter, a portable machine with multiple cables that connect to the electrodes on the chest. Total wear of both devices, the service of ZIO time detected events of arrhythmia 57% more in comparison with the Holter monitor (96 against 61), mainly due to the prolonged monitoring. The doctors also reported that they reached a definitive diagnosis in 90% of cases using the ZIO service, compared with 64% with the Holter monitor. In addition, 81% of the patients reported that they preferred the ZIO patch versus the Holter monitor.
"The traditional options of monitoring heart are limited in their ability to capture the arrhythmias, which are rare and often do not have symptoms, and because they are difficult for patients to comply", said Kevin King, President and Chief Executive Officer of iRhythm. "These studies findings underscore that the ZIO service is setting a new standard for the diagnosis of arrhythmia, with a focus continuous monitoring proven, long-term which allows doctors to rule in and rule out arrhythmias before in the way of diagnosis and change the treatment of the patients."Each year, millions of patients presenting with low common and non-specific symptoms such as palpitations, dizziness, and shortness of breath, which may or may not be caused by cardiac arrhythmias. Reports estimate that the three most common types of arrhythmia, atrial fibrillation (AF), bradycardia and ventricular tachycardia - affect approximately 8 million people in the United States each year. If it is not correctly, arrhythmias can lead to serious complications such as stroke. Effective management of cardiac arrhythmia is specific to the identified type of arrhythmia. Arrhythmias, however, are often difficult to diagnose using techniques of monitoring current, that they are limited in what you can record or it can be difficult for patients to use or tolerate.
About ZIO serviceService ZIO, ZIO, patented algorithms patch and ZIO report, is recognized more and more as the new standard for patients with suspected arrhythmia ambulatory cardiac monitoring. ZIO patch is a non-invasive, resistant to water, which is easy to use and discreet to wear, high compliance of the patient and a higher diagnostic yield. Proprietary algorithms analyze the data hit captured heart and provides a concise report to the patient's physician. Since its commercial launch in 2011, has been ZIO service with more than 200,000 patients in nearly 800 institutions throughout the country. ZIO is covered by most Medicare patients and main payers private throughout the country, representing more than 150 million of lives covered.
About iRhythm Technologies, Inc.
iRhythm is a company of services of health information that aims to be the world leader in information of cardiac arrhythmia management, a large and growing clinical need. Your solution of ship logo, ZIO service, offers an approach proven for continuous monitoring in the long term that allows early diagnosis in the clinical way to improve patient outcomes and reduce healthcare costs. For more information, visit www.irhythmtech.com.
Tracy Morris
650-380-4413
tracymorrispr@gmail.com
SOURCE iRhythm Technologies
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http://www.irhythmtech.com