Volume 11.32 | Aug 23

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]

STEMcircles_645x110


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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