Cell Therapy News Volume 11.32 | Aug 23 2010

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    Cell Therapy News 11.32, August 23, 2010.
    In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  |  Unsubscribe

    TOP STORY  

    Surprise in Genome Structure Linked to Developmental Diseases
    Researchers have discovered that each cell type in our bodies has a unique genome structure, which is due to a newly discovered mechanism that controls our genes. [Press release from the Whitehead Institute for Biomedical Research discussing online prepublication in Nature]

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    SCIENCE NEWS

    RNA Snippets Control Protein Production by Disabling mRNAs
    MicroRNAs control protein production by causing messenger RNA to be disabled by the cell, according to scientists. [Press release from the Whitehead Institute for Biomedical Research discussing online prepublication in Nature]

    Stem Cells from the Thymus Reprogrammed to Become Skin Stem Cells
    The study shows that stem cells from the thymus can function as hair follicle stem cells and contribute to the long-term maintenance of the skin. [Press release from the Medical Research Council Centre for Regenerative Medicine discussing online prepublication in Nature]
     
    Genetic Signature in TB Patients Sheds Light on Disease
    Scientists have uncovered a ‘genetic signature’ in the blood of patients with active tuberculosis (TB). [Press release from the Medical Research Council discussing online prepublication in Nature]
     
    Cancer’s ‘Addiction’ Spurs New Treatment Hopes
    Cancer can call upon a bewildering array of genetic tricks to wreak havoc, but researchers show that the disease can become dependent upon a tiny gene that allows it to adapt and proliferate. [Press release from Yale Cancer Center discussing online prepublication in Nature]
     
    Human Cells Can Copy not Only DNA, but Also RNA
    Single-molecule sequencing technology has detected and quantified novel small RNAs in human cells that represent entirely new classes of the gene-translating molecules, confirming a long-held but unproven hypothesis that mammalian cells are capable of synthesizing RNA by copying RNA molecules directly. [Press release from the University of Pittsburgh School of Medicine discussing online prepublication in Nature]
     
    Researchers Identify Gene Linked to TB Susceptibility in Africans
    A consortium of researchers has successfully used genome scanning to identify a gene associated with increased susceptibility to tuberculosis (TB) in African populations. [Press release from the University of Otago discussing online prepublication in Nature Genetics]
     
    Muscles Examined in Cancer Study
    Scientists discovered a way to prevent the withering away of muscles in mice with cancer. [Press release from the Press Association discussing online prepublication in Cell]

    Discovery Opens Door to Therapeutic Development for FSH Muscular Dystrophy
    Scientists are closer to understanding what triggers muscle damage in one of the most common forms of muscular dystrophy, called facioscapulohumeral (FSH) muscular dystrophy. [Press release from the National Institutes of Health discussing online prepublication in Science]
     
    ‘Starvation Gene’ Could Make Resistance Futile for Ovarian Cancer Cells
    Researchers have found a new player in ovarian cancer drug resistance — a gene previously only known to be involved in helping fat and liver cells recover from starvation. [Press release from Cancer Research UK discussing online prepublication in Cancer Cell]
     
    Selected Cells from Blood or Bone Marrow May Provide a Route to Healing Blood Vessels
    Isolating cells from a patient’s blood or bone marrow that nourish blood vessels may be a safer and less arduous route to treatment of cardiovascular disease than obtaining rare stem cells. [Press release from Emory University Woodruff Health Sciences Center discussing online prepublication in the Journal of the American College of Cardiology]
     
    Slippery DNA Holds Clues to Fighting Diseases that Progress with Age
    Researchers are aware of some 40 neurological, neurodegenerative and neuromuscular diseases that share a common element — they contain mutations in the form of repeating DNA that grows longer through the life of a patient, making the condition worsen. In an international study, they uncovered the workings behind this dynamic mutation. [Press release from the Hospital for Sick Children discussing online prepublication in Nature Structural and Molecular Biology]
     
    A 'Kill Switch' for Rogue Microbes
    Researchers have developed a highly tunable genetic “switch” that offers a greater degree of control over microbes. [Press release from Massachusetts Institute of Technology discussing online prepublication in the Proceedings of the National Academy of Sciences USA]
     
    New Stem Cell Discovery a Preliminary Step for Regenerative Medicine
    Researchers found that the inclusion of vitamin C in cell culture media was responsible for chemical modification of DNA which has been known to cause chromosome instability and cancer in laboratory stem cell populations. [Press release from the University of Queensland discussing online prepublication in Stem Cells]
     
    Breakthrough Gene Therapy Prevents Retinal Degeneration
    Researchers demonstrated that non-viral gene therapy can delay the onset of some forms of eye disease and preserve vision. [Press release from Tufts University School of Medicine discussing online prepublication in Molecular Therapy]
     
    Human Neural Stem Cells Restore Motor Function in Mice with Chronic Spinal Cord Injury
    A study is the first to demonstrate that human neural stem cells can restore mobility in cases of chronic spinal cord injury, suggesting the prospect of treating a much broader population of patients. [Press release from the University of California, Irvine discussing online prepublication in PLoS One]
     
    Australian Scientists in Stem Cell First
    Researchers at the University of New South Wales have found a way to generate known as induced pluripotent stem cells without introducing the risk of troublesome “foreign DNA”. [Press release from The Age discussing online prepublication in PLoS One]
     
    Scientific Breakthrough as Red Blood Cells Are Made from IVF Embryos
    British scientists have turned stem cells from spare IVF embryos into red blood cells as part of a project to manufacture synthetic blood on an industrial-scale. [The Independent]

    CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

    Mediator and Cohesin Connect Gene Expression and Chromatin Architecture
    Researchers report that mediator and cohesin physically and functionally connect the enhancers and core promoters of active genes in murine embryonic stem cells. [Nature]
     
    Mammalian MicroRNAs Predominantly Act to Decrease Target mRNA Levels
    Results show that changes in mRNA levels closely reflect the impact of microRNAs on gene expression and indicate that destabilization of target mRNAs is the predominant reason for reduced protein output. [Nature]
     
    Microenvironmental Reprogramming of Thymic Epithelial Cells to Skin Multipotent Stem Cells
    Researchers show that the thymus of the rat contains a population of clonogenic thymic epithelial cells that can be extensively cultured while conserving the capacity to integrate in a thymic epithelial network and to express major histocompatibility complex class II molecules and Aire. [Nature]
     
    An Interferon-Inducible Neutrophil-Driven Blood Transcriptional Signature in Human Tuberculosis
    The studies demonstrate a hitherto underappreciated role of type I interferon-(alpha)(beta) signaling in the pathogenesis of tuberculosis, which has implications for vaccine and therapeutic development. [Nature]
     
    OncomiR Addiction in an In Vivo Model of MicroRNA-21-Induced Pre-B-Cell Lymphoma
    Results demonstrate that tumors can become addicted to oncomiRs and support efforts to treat human cancers through pharmacological inactivation of microRNAs such as miR-21. [Nature]

    New Class of Gene-Termini-Associated Human RNAs Suggests a Novel RNA Copying Mechanism
    Researchers show that human cells contain a novel type of sRNA that has non-genomically encoded 5' poly(U) tails. The presence of these RNAs at the termini of genes, specifically at the very 3' ends of known mRNAs, strongly argues for the presence of a yet uncharacterized endogenous biochemical pathway in cells that can copy RNA. [Nature]

    Genome-Wide Association Analyses Identifies a Susceptibility Locus for Tuberculosis on Chromosome 18q11.2
    The study demonstrates that genome-wide association studies can identify new susceptibility loci for infectious diseases, even in African populations, in which levels of linkage disequilibrium are particularly low. [Nat Genet]
     
    Reversal of Cancer Cachexia and Muscle Wasting by ActRIIB Antagonism Leads to Prolonged Survival
    Researchers show that in several cancer cachexia models, pharmacological blockade of ActRIIB pathway not only prevents further muscle wasting but also completely reverses prior loss of skeletal muscle and cancer-induced cardiac atrophy. [Cell]

    A Unifying Genetic Model for Facioscapulohumeral Muscular Dystrophy
    Researchers show that facioscapulohumeral muscular dystrophy patients carry specific single nucleotide polymorphisms in the chromosomal region distal to the last D4Z4 repeat. [Science]

    SIK2 Is a Centrosome Kinase Required for Bipolar Mitotic Spindle Formation that Provides a Potential Target for Therapy in Ovarian Cancer
    Researchers show that the salt inducible kinase 2 (SIK2) localizes at the centrosome, plays a key role in the initiation of mitosis, and regulates the localization of the centrosome linker protein, C-Nap1, through S2392 phosphorylation. [Cancer Cell]

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    POLICY

    Review Calls for New Federal Approach to Medical Countermeasures
    U.S. Department of Health and Human Services Secretary Kathleen Sebelius released an examination of the federal government’s system to produce medications, vaccines, equipment and supplies needed for a health emergency, known as medical countermeasures. [Department of Health and Human Services, United States]

    Enhancing Research in Regenerative Medicine
    The American Society of Hematology (ASH) convened a working group of experts from the fields of hematopoietic stem cell biology, embryonic stem cells, transplantation biology, and gene therapy at the urging of the Committee on Government Affairs with the goal of developing a “white paper” to inform recommendations to ASH and appropriate parties at the National Institutes of Health about the need for additional research in the area of regenerative medicine. [Blood]

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    BUSINESS

    International Society for Cellular Therapy (ISCT) Joins Forces with Roche and Genzyme to Launch Cell Therapy Industry Partnership
    Many companies in the cell therapy regenerative medicine market including Roche, Genzyme, Athersys, Miltenyi Biotec, Hospira, Lonza and Life Technologies will join ISCT to launch a series of new initiatives that will create greater strategic alignment within the industry and drive late stage clinical development. [International Society for Cellular Therapy Press Release]
     
    ASH Recommends Cross-Disciplinary Engagement to Advance Regenerative Medicine
    The American Society of Hematology (ASH) has developed specific recommendations to the scientific community and federal agencies to help propel collaborative research in regenerative medicine in order to make real strides in improving patient care. These recommendations were released in Blood. [American Society of Hematology Press Release]

    Quark Pharmaceuticals and Major Pharmaceutical Company Enter into Licensing Option Agreement for the p53 Suppressor Drug QPI-1002, the First siRNA Administered Systemically in Human
    Quark Pharmaceuticals, Inc. announced that it has granted Novartis an option to obtain an exclusive worldwide license to develop and commercialize its p53 temporary inhibitor siRNA drug QPI-1002, currently the subject of a Phase II clinical trial. [Quark Pharmaceuticals, Inc. Press Release]

    Cryo-Cell Announces Célle(SM) Research and Development Collaboration with Department of Medicine, Monash University
    Cryo-Cell International, Inc. announced a research and development collaboration agreement with Monash University in Australia. [Cryo-Cell International, Inc. Press Release]
     
    Oxford BioMedica Announces Licensing Agreement with Emergent BioSolutions Inc.
    Oxford BioMedica announced that it has signed a licensing agreement with Emergent Product Development Germany GmbH. [Oxford BioMedica Press Release]
     
    Proteonomix, Inc. Announces Joint Venture in the United Arab Emirates
    Proteonomix, Inc. announced that it has executed a joint venture agreement with a group of investors that will create a new stem cell treatment and research facility in the United Arab Emirates. [Proteonomix, Inc. Press Release]
     
    Life Technologies Announces Agreement to Acquire Ion Torrent
    Life Technologies Corporation announced a definitive agreement to acquire Ion Torrent for $375 million in cash and stock. [Life Technologies Corporation Press Release]

    BioMarin Acquires ZyStor Therapeutics, Inc.
    BioMarin Pharmaceutical Inc. announced that it has acquired ZyStor Therapeutics, Inc. [BioMarin Pharmaceutical Inc. Press Release]

    Emerging Healthcare Solutions Inks Option for Breakthrough Stem Cell Technology
    Emerging Healthcare Solutions, Inc. announced that the Company has signed an option with Regenevita, owner of the right to license Neo Natal Progenitor Cell Expansion Technology in Latin America. [Yahoo! Finance]

    Stem Cell Agency Commits $243 Million, Expands Team Approach to Developing New Therapies
    The Governing Board of the California Institute for Regenerative Medicine approved the concept for up to $243 million round of funding to move stem cell-based therapies to clinical trial. [California Institute for Regenerative Medicine Press Release]
     
    Complete Genomics, Inc. Announces Completion of $39 Million Series E Financing and Addresses Illumina Patent Infringement Lawsuit
    Complete Genomics announced that it has raised $39 million in its Series E funding round. [Complete Genomics, Inc. Press Release]
     
    NSF Awards $3 Million Stem Cell Bio-Manufacturing Program to Georgia Tech
    The National Science Foundation (NSF) has awarded $3 million to the Georgia Institute of Technology to fund a unique research program on stem cell bio-manufacturing. [Georgia Institute of Technology Press Release]
     
    Sanofi Seeks Efficiencies with New Model
    Sanofi-aventis is dividing its vast resources into decentralized disease-based units, each with its own departments for research and development, regulatory affairs, marketing, and sales — a plan designed to identify promising drugs more quickly and weed out failures before spending billions on unsuccessful clinical trials. [The Boston Globe]



    NIH

    NIH Launches Effort to Define Markers of Human Immune Responses to Infection and Vaccination
    A new nationwide research initiative has been launched to define changes in the human immune system, using human and not animal studies, in response to infection or to vaccination.

    Lawrence A. Tabak Named Principal Deputy Director NIH
    National Institutes of Health Director Francis S. Collins, M.D., Ph.D., announced the appointment of Lawrence A. Tabak, D.D.S., Ph.D., as principal deputy director of the National Institutes of Health.
     
    Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) (R01) (RFA-GM-11-003)

    Proposed Collection; Comment Request; STAR METRICS–Science and Technology in America's Reinvestment: Measuring the Effects of Research on Innovation, Competitiveness and Science (FR Doc. 2010-20614)

    National Heart, Lung, and Blood Institute; Notice of Closed Meetings (FR Doc. 2010-20291)

    Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2010-20287)

    Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-20588)

    Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc. 2010-20675)

    NIH-RAID Updates on Program Scope and Procedures: Biologics Manufacture, Lead Selection, and Product Development Plans (NOT-RM-10-012)

    Support of National Institute of General Medical Sciences Program Project Grants (P01) (PAR-10-266)



    CBER

    SparVax (Recombinant Protective Antigen (rPA) Anthrax Vaccine) – Untitled Letter

    Complete List of Currently Approved NDA and ANDA Application Submissions (PDF – 62KB) 

    Complete List of Currently Approved Premarket Approvals (PMAs) (PDF – 27KB)



    REGULATORY

    FOOD AND DRUG ADMINISTRATION (United States)

    GlaxoSmithKline and Human Genome Sciences Announce FDA Priority Review Designation for Benlysta® (Belimumab) as a Potential Treatment for Systemic Lupus Erythematosus
    GlaxoSmithKline PLC and Human Genome Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus.

    Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma
    Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the Biologics License Application for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated.

    FDA, Companies Must Stretch Overseas Supply Oversight
    The FDA is trying to stretch its enforcement reach over foreign drug suppliers, potentially through consent decrees, and is asking manufacturers to take bigger steps as well to tighten the pharmaceutical supply chain.

    The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application


    EVENTS (Listed by Date)

    Select Biosciences 3rd Annual Stem Cells Europe Conference
    August 24-25, 2010
    Edinburgh, Scotland

    Select Biosciences 2nd Annual World Biobanking Summit
    August 24-25, 2010
    Edinburgh, Scotland

    Select Biosciences Inaugural Cellular Therapy Summit
    August 24-25, 2010
    Edinburgh, Scotland

    Viral Vectors in Gene Therapy: Applications and Novel Production Methods
    August 26-September 4, 2010
    Kuopio, Finland

    European Workshop on Skin Stem Cells
    August 31-September 2, 2010
    Cambridge, United Kingdom

    Clinical Trials International Summit 2010
    September 1-2, 2010
    Shanghai, China

    Third Annual Limbal Stem Cell Meeting
    September 10, 2010
    Reading, United Kingdom

    International Society for Cellular Therapy (ISCT) – Europe 2nd Regional Meeting
    September 11-14, 2010
    Belgirate, Italy

    Hydra VI: The European Summer School on Stem Cells & Regenerative Medicine
    September 11-17, 2010
    Hydra, Greece

    Joint Metastasis Research Society – American Association of Cancer Research Conference on Metastasis and the Tumor Microenvironment
    September 12-15, 2010
    Philadelphia, United States

    Stem Cells USA & Regenerative Medicine Congress 2010
    September 13-15, 2010
    Philadelphia, United States

    Select Biosciences 7th Annual RNAi & miRNA Europe
    September 14-15, 2010
    Dublin, Ireland

    Select Biosciences Inaugural Epigenetics Europe Conference
    September 14-15, 2010
    Dublin, Ireland

    Select Biosciences Inaugural Genomics Automation Europe Conference
    September 14-15, 2010
    Dublin, Ireland

    Tissue Engineering & Regenerative Medicine International Society (TERMIS) – Asia Pacific 2010
    September 15-17, 2010
    Sydney, Australia

    First Annual BIO India International Partnering Conference
    September 21-22, 2010
    Hyderabad, India

    Cellular Therapy of Cancer Symposium – ATTACK Project Meeting
    September 24-27, 2010
    Montpellier, France

    International Society for Cellular Therapy 2nd Annual Symposium on Stem Cell Translation: Best Practices & Regulatory Considerations
    September 27-28, 2010
    San Francisco, United States

    International Society for Cell and Gene Therapy of Cancer (ISCGT) Congress
    September 27-29, 2010
    Doha, Qatar

    4th American Association of Cancer Research International Conference on Molecular Diagnostics in Cancer Therapeutic Development
    September 27-30, 2010
    Denver, United States

    Select Biosciences 6th Annual Ion Channel Targets Conference
    September 28-29, 2010
    Washington, DC, United States

    Cytokines 2010: Cytokines in Infectious Diseases, Autoimmune Disorders and Cancer
    October 3-7, 2010
    Chicago, United States

    2010 World Stem Cell Summit
    October 4-6, 2010
    Detroit, United States

    9th Annual BIO Investor Forum
    October 5-6, 2010
    San Francisco, United States

    5th World Congress on Preventive & Regenerative Medicine (WCRM)
    October 5-7, 2010
    Hannover, Germany

    17th Annual Meeting German Society for Gene Therapy (DG-GT e.V.)
    October 6-9, 2010
    Munich, Germany

    COGEM Symposium: GM Viruses as Medicine: Panacea or Pandora's Box?
    October 7, 2010
    Amsterdam, The Netherlands

    American Association of Blood Banks (AABB) Annual Meeting & Cellular Therapy and Transfusion Medicine Expo (CTTXPO) 2010
    October 9-12, 2010
    Baltimore, United States

    18th Annual BioPartnering Europe
    October 10-12, 2010
    London, United Kingdom

    NEW 3rd Biobridge “Generation Regeneration” Conference
    October 11, 2010
    Geneva, Switzerland

    New York Stem Cell Foundation Fifth Annual Translational Stem Cell Research Meeting
    October 12-13, 2010
    New York, United States

    Translational Cancer Research for Basic Scientists
    October 17-22, 2010
    Boston, United States

    2010 NanoMedicine Summit
    October 18-19, 2010
    Cleveland, United States

    BIO Intellectual Property Counsels Committee Fall Conference and Committee Meeting
    October 18-20, 2010
    Boston, United States

    European Society of Gene and Cell Therapy (ESGCT) 18th Annual Congress
    October 22-25, 2010
    Milan, Italy

    3rd Annual Dubai Congress on Anti-Aging and Aesthetic Medicine (DCAAAM)
    October 26-27, 2010
    Dubai, United Arab Emirates

    World Stem Cells & Regenerative Medicine Congress Asia 2010
    October 26-29, 2010
    Singapore City, Singapore

    Select Biosciences 3rd Annual Molecular Diagnostics World Congress
    October 28-29, 2010
    San Diego, United States

    Fraunhofer Life Science Symposium 2010
    October 29-30, 2010
    Leipzig, Germany

    Stem Cell Society Singapore Symposium 2010: Translating Science to Therapy
    November 2-3, 2010
    Singapore City, Singapore

    BioMalaysia 2010 Conference and Exhibition
    November 2-4, 2010
    Kuala Lumpur, Malaysia

    World Cord Blood Congress
    November 4-7, 2010
    Marseille, France

    Select Biosciences 5th Annual European Biomarkers Summit
    November 9-10, 2010
    Florence, Italy

    Select Biosciences International Forum on Stem Cells
    November 12-13, 2010
    Tianjin, China

    Select Biosciences 2nd Annual RNAi Asia Conference
    November 15-16, 2010
    Singapore City, Singapore

    BIO-Europe International Partnering Conference
    November 15-17, 2010
    Munich, Germany

    9th Annual Gene Therapy Symposium for Heart, Lung, and Blood Diseases
    November 17-19, 2010
    Sonoma, United States

    8th Annual Commercial Translation of Regenerative Medicine Conference
    November 18-19, 2010
    London, United Kingdom

    Stem Cell Network 10th Annual Scientific Meeting
    November 22-24, 2010
    Calgary, Canada

    HealthTech and Medicines Knowledge Transfer Network 7th Annual BioProcessUK Conference
    November 24-25, 2010
    Manchester, United Kingdom

    2nd European Association for Cardio-Thoracic Surgery (EACTS) Meeting on Cardiac and Pulmonary Regeneration
    December 2-3, 2010
    Vienna, Austria

    Tissue Engineering & Regenerative Medicine International Society (TERMIS) – North America 2010 Annual Conference
    December 5-8, 2010
    Orlando, United States

    Select Biosciences 5th Annual Stem Cells World Congress
    January 24-25, 2011
    San Diego, United States

    BIO Asia International Partnering Conference
    January 24-25, 2011
    Tokyo, Japan

    Phacilitate 7th Annual Cell & Gene Therapy Forum 2011
    January 24-26, 2011
    Washington DC, United States

    Visit our events page to stay up to date with the latest events in the cell, gene and immunotherapy community.


     

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