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Sanofi Announces Upcoming Launch of MyStar Extra, the First Self-Monitoring Blood Glucose Meter With Estimated A1c

At the annual meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain, Sanofi (EURONEXT : SAN and NYSE : SNY) recently presented the innovative blood glucose meter MyStar Extra®, the first self-monitoring device that provides robust estimates of the A1c value, a key indicator for long-term glucose control.[3],[4] The hemoglobin A1C (HbA1C) assay has become the cornerstone for the assessment of diabetes control and A1c test results are widely used to guide treatment decisions.[5],[6] Especially convenient for people starting on insulin or using insulin, MyStar Extra® is a supportive meter, designed to help people with diabetes be engaged in their insulin management and treatment plan.[7],[8],[9]

Northwestern Medicine Enrolls First Participant in Midwest for Research Study of Personalized Vaccine for Aggressive Brain Tumors

Northwestern Medicine® recently joined a landmark clinical trial to investigate if a vaccine made from a patient’s own brain tumor is effective in slowing tumor progression and extending survival. The randomized phase II trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM). The study is the largest randomized brain tumor vaccine trial ever funded by the National Cancer Institute (NCI) and is chaired by Andrew T. Parsa, MD, PhD, who joined Northwestern Memorial Hospital in July as the new chair of neurological surgery. The first participant in the Midwest, and only third in the country, was enrolled in the trial last week at Northwestern Memorial.

The trial will enroll more than 200 participants with recurrent glioblastoma that can be surgically removed. Following the participant’s surgery, the tumor is sent to an industry collaborator Agenus Inc., where the participant’s specific personalized vaccine, designated as HSPPC-96, is created. The vaccine is unique to the individual participant and is engineered to trigger an immune system response to kill tumor cells that may remain following surgery.

“This is truly personalized medicine where the patient’s own tumor is being used to help fight their cancer,” said Parsa, who is also the Michael J. Marchese Professor and chair of the department of neurological surgery at Northwestern University Feinberg School of Medicine and a member of the of Robert H. Lurie Comprehensive Cancer Center of Northwestern University and part of the Northwestern Brain Tumor Institute. “The vaccine provokes a tumor-specific immune response that is specific to that patient. The T cells, which are the part of the immune system that fights disease, tracks down the cancer cells and kills them.”

Parsa launched this area of research in 2006 at the University of California, San Francisco (UCSF). Previous phases of this research have returned promising results finding that the vaccine extended survival for participants with glioblastoma when compared to standard therapies. In this next phase, researchers are seeking to understand if the vaccine is safe and more effective when given with Avastin, a drug that is known to shrink brain tumors and is a standard therapy for recurrent glioblastoma. Trial participants will be randomized to either receive the vaccine alone, concurrently with Avastin or Avastin only. Jeffrey Raizer, MD, co-director of the Northwestern Brain Tumor Institute (NBTI), is the principal investigator for the trial at Northwestern.

“This vaccine therapy has the potential to extend the lives of patients who often have limited options when their tumor returns,” said Raizer, medical director of neuro-oncology at Northwestern Memorial, associate professor of neurology at the Feinberg School and a member of the Lurie Cancer Center. “Previous results indicate that we may be able to extend survival longer by combining the therapy with other drugs, such as Avastin, that may boost the immune response of the vaccine.”

Each year, 17,000 Americans are diagnosed with glioblastoma, a particularly aggressive form of brain cancer. This type of tumor is often resistant to standard therapies and median survival is approximately 15 months from the point of first diagnosis.

“This research does not present a cure for brain tumors, but instead a potential way to convert the cancer into a chronic disease – something comparable to diabetes that you may be able to live with and control with medication,” said Parsa.

A successful trial could lead to the vaccine potentially being approved to treat recurrent brain tumors, making it one of only a few approved therapeutic cancer vaccines.

“Vaccine therapy is rapidly emerging as a potential treatment for many types of cancers and we’re proud that Northwestern is part of this exciting research,” said Steven T. Rosen, MD, director of the Lurie Cancer Center, director of cancer programs at Northwestern Memorial, and Genevieve E. Teuton Professor of Medicine at the Feinberg School. “This field of research has the potential to offer safer and less toxic cancer therapies that can be personalized to each individual patient.”

The study is sponsored by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI, and the vaccine is being developed by Agenus Inc. Parsa has not received any financial support or travel expense from the company.

To learn more about the clinical trial, call 312-695-2047 or email kskirnyk@nmff.org. Enrollment criteria can be viewed on the Lurie Cancer Center website.

Northwestern’s neurology and neurological surgery program is ranked as 7th in the country on the U.S. News & World Report 2013-14 Best Hospitals specialty rankings and 1st in Chicago. This is the seventh consecutive year that Northwestern is the highest ranked neurological program in Illinois and Chicago. The departments of neurology and neurological surgery provide treatment for a full range of neurological disorders and offer patients the latest and most sophisticated treatment and surgical options. Our neurologists and neurosurgeons are actively engaged in clinical research to advance new therapies and uncover the causes and cures of neurological diseases.

Source: PR Newswire

University Of California, San Diego School Of Medicine To Investigate Risk Factors For Parkinson’s Disease Via Parkinson’s Progression Markers Initiative (PPMI)

University of California, San Diego School of Medicine will be one of 23 official clinical sites of the Parkinson’s Progression Markers Initiative’s (PPMI) new arm to study at-risk populations for Parkinson’s disease (PD). The $55 million landmark observational clinical study launched in 2010 to define one or more biomarkers of PD and now seeks to better understand potential risk factors of the disease. The University of California, San Diego School of Medicine has been a part of PPMI for three years and is currently enrolling for the new, pre-motor arm of the study.

The pre-motor arm of PPMI will enroll participants who do not have Parkinson’s disease and are living with one of three potential risk factors for PD: a reduced sense of smell (hyposmia); rapid eye movement sleep behavior disorder (RBD); or a mutation in the LRRK2 gene (the single greatest genetic contributor to PD known to date). Validating these risk factors could not only enable earlier detection of the disease, but open new avenues in the quest for therapies that could slow or stop disease progression.

“Understanding risk factors for Parkinson’s disease could help to identify therapies that may prevent the onset of motor symptoms in future generations of PD patients,” said Douglas Galasko, MD, the principal investigator for the study at the University of California, San Diego School of Medicine.

Local residents can easily get involved in this research by being one of 10,000 individuals needed to complete a brief online survey (www.michaeljfox.org/takethesmellsurvey) about their sense of smell. People over the age of 60 who do not have Parkinson’s disease are needed to take the survey. Most respondents will be sent a scratch-and-sniff smell test and brief questionnaire in the mail to be completed at home. Some individuals may also be asked to undergo more extensive testing.

“In the third year of PPMI, it is evident that a large-scale biomarker study is not only possible in Parkinson’s disease, but is already yielding scientific insights that could help transform the field of Parkinson’s research,” said Todd Sherer, PhD, CEO of The Michael J. Fox Foundation for Parkinson’s Research. “None of this progress would be possible without the willing volunteers who donate their time and energy to the pursuit of a cure.”

Source: PR Newswire

Syapse Joins Free the Data! Initiative and Provides Software to Power Participant-centric Hereditary Gene Mutation Database

Syapse, the leader in software for bringing omics into routine medical use, announced that it has joined the Free the Data! initiative. This consortium of policy makers, advocacy organizations, individuals, academic centers, and industry aims to fill the public information gap caused by the lack of available genetic information for the BRCA1 and BRCA2 genes, and plans to expand to provide other types of genetic information in an open, searchable database.

Syapse will provide the software infrastructure for the Free the Data! initiative, enabling powerful data mining, visualization, and reporting. Participants will be able to visualize their own variations and clinical data in comparison to those already in the database, while clinicians will be able to utilize variant interpretation in medical interactions. Researchers, industry, and others can utilize Syapse data mining tools to interrogate the variants, interpretation, and evidence, along with clinical data submitted by participants. Participants will have full control over data sharing and privacy preferences of the data they contribute. The campaign shares all variants with ClinVar, the National Institutes of Health public database, unless the participant dictates otherwise.

“Despite national attention on the patentability of human genes, a ruling against gene patentability doesn’t immediately provide broad access to BRCA1 and BRCA2 variants or place them in a public database that will allow for better diagnosis and care,” said Sharon F. Terry, M.A., president and CEO of Genetic Alliance. “Syapse provides the best platform for integrating complex genomics and clinical data from disparate sources, and reporting it in a dynamic and relevant interface to participants and clinicians. We are excited to be using Syapse software to enable all individuals to access genetic mutations and their clinical interpretations in order to improve care.”

“Syapse is pleased to join Genetic Alliance, University of California San Francisco (UCSF), InVitae Corporation, and advocates in the Free the Data! initiative to crowdsource the interpretation of BRCA1 and BRCA2 variants,” said Jonathan Hirsch, Founder & President of Syapse. “Syapse is committed to the free and open interpretation of the genome, but interpreting the genome requires a larger evidence base than any one entity can develop. Pooling genetic and clinical data will rapidly advance medical knowledge of clinically relevant genetic mutations, leading to more effective diagnosis, treatment, and cures.”

Individuals who have received genetic testing and who are interested in participating are invited to go to the Free The Data! project web site at www.free-the-data.org, and follow the instructions to upload test results, set privacy and sharing settings, and answer a brief questionnaire.

Individuals may also send a scan or PDF of the test report form with the personal identifying information blocked to Genetic Alliance by email at freethedata@geneticalliance.org or by facsimile at 202.966.8553.

We encourage individuals, advocacy groups, research organizations, physicians, policy groups, professional societies and industry to join the cause. For more information, please visit free-the-data.org or contact: 202.966.5557 x201.

Source: Synapse

Big Data From Alzheimer’s Disease Whole Genome Sequencing Will Be Available to Researchers Due to Novel Global Research Database

The Alzheimer’s Association and the Brin Wojcicki Foundation announced recently that massive amounts of new data have been generated by the first “Big Data” project for Alzheimer’s disease. The data will be made freely available to researchers worldwide to quickly advance Alzheimer’s science.

Discussed recently at the Alzheimer’s Association International Conference (AAIC) 2013 in Boston, the project obtained whole genome sequences on the largest cohort of individuals related to a single disease – more than 800 people enrolled in the Alzheimer’s Disease Neuroimaging Initiative (ADNI).

The genome sequencing data – estimated to be 200 terabytes – will be housed in and available through the Global Alzheimer’s Association Interactive Network (GAAIN), a planned massive network of Alzheimer’s disease research data made available by the world’s foremost Alzheimer’s researchers from their own laboratories, and which also is being publicly announced today at AAIC 2013. GAAIN is funded by an initial $5 million dollar investment by the Alzheimer’s Association, made possible due to the generous support of donors.

“The Alzheimer’s Association is committed to creating open access to research data, and we believe GAAIN will transform how neuroscience data is shared and accessed by scientists throughout the world,” said Maria Carrillo, Ph.D., Alzheimer’s Association vice president of Medical and Scientific Relations. “By fostering a higher level of global data sharing, GAAIN will accelerate investigation and discovery in Alzheimer’s through a system comparable to a search engine like Google or Bing for relevant data.”

“With the addition of more than 800 whole genomes on ADNI subjects that can be linked to the current rich dataset, ADNI data will be even more useful to scientists who are seeking new approaches to treatment and prevention of Alzheimer’s disease,” said Robert C. Green, M.D., M.P.H., of Brigham and Women’s Hospital and Harvard Medical School, who led the ADNI sequencing project. “ADNI is a leader in open data sharing, having provided clinical, imaging and biomarker data to over 4,000 qualified scientists around the world, which has generated over 700 scientific manuscripts.

First, Massive Whole Genome Sequencing Project in Alzheimer’s Disease

Whole genome sequencing determines all six billion letters in an individual’s DNA in one comprehensive analysis. The raw data from the ADNI project is being made available to qualified scientists around the globe to mine for novel targets for risk assessment, new therapies, and much-needed insight into the causes of the fatal brain disease. The new data may enable scientists to better understand how our genes cause and are affected by bodily changes associated with Alzheimer’s disease.

ADNI enrolls people with Alzheimer’s disease, mild cognitive impairment, and normal cognition who have agreed to be studied in great detail over time. The goal is to identify and understand markers of the disease in body fluids, structural changes in the brain, and measures of memory; the hope is to improve early diagnosis and accelerate the discovery of new treatments. ADNI is led by Principal Investigator Michael W. Weiner, M.D., of the University of California San Francisco and the San Francisco VA Medical Center. Dr. Green collaborated on managing the sequencing efforts with Arthur Toga, Ph.D., of UCLA and Andrew J. Saykin, Psy.D., of Indiana University. The actual genome sequencing was performed at Illumina, Inc.

ADNI is a public-private research project led by the National Institutes of Health (NIH) with private sector support through the Foundation for NIH. Launched in 2004, ADNI’s public-private funding consortium includes pharmaceutical companies, science-related businesses, and nonprofit organizations including the Alzheimer’s Association and the Northern California Institute for Research and Education.

The Global Alzheimer’s Association Interactive Network (GAAIN)

Data-sharing has already greatly benefitted scientific disciplines such as genetics, molecular biology, and the physical sciences. Data-sharing in genetics has led to dramatic advances in understanding the risk factors underlying complex diseases. The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a compelling example of dozens of geographically-dispersed researchers working together to share their data while making it freely available to others for analysis and publication.

“GAAIN is similar in spirit and goals to other ‘big data’ initiatives that seek to greatly improve the tools and techniques needed to access, organize, and make discoveries from huge volumes of digital data,” Carrillo said. “The advent of cloud computing makes it possible to link databases throughout the world and expand their data processing capability significantly to benefit the research community.”

Carrillo will supervise the development of GAAIN in conjunction with co-principal investigators Art Toga, Ph.D., of the Laboratory of Neuro Imaging (LONI) at the University of Southern California and Giovanni Frisoni, M.D., of the National Center for Alzheimer’s Disease Research and Care and the Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Fatebenefratelli Hospital, Italy. Enrique Castro-Leon, Ph.D., who will serve as a consultant, is an enterprise and data center architect for strategic partner Intel Digital Enterprise Group.

GAAIN is built on an international database framework already in use by thousands of scientists and local computational facilities in North America and Europe. The network makes research data available free-of-charge for searching, downloading, and processing across a cloud-based, grid-network infrastructure accessible anywhere through Internet access.

The key to GAAIN’s innovation is its federation of data, which is unprecedented for such a system. GAAIN leadership will invite scientists conducting qualified studies to become partners by permitting GAAIN to link directly to their databases. This will enable researchers to add continually to their data sets and keep all data in GAAIN current and dynamic. It also will enable the scientists to retain control over access to their data, which the Association believes will be important to encouraging participation.

“This is unprecedented and of the utmost importance in brain research, where sometimes thousands of examples are required to observe even the smallest change in the brain,” said Giovanni Frisoni, M.D., neurologist and deputy scientific director at the National Center for Alzheimer’s Disease Research and Care at the IRCCS. He will lead the work of GAAIN in Europe.

“Through GAAIN we envision combining massive amounts of data from multiple sources across many subjects participating in numerous studies,” said Art Toga, Ph.D., professor of neurology at UCLA and director of LONI. “This will provide more statistical power than ever before.”

Source: Alzheimer’s Association