Volume 11.24 | Jun 28

Cell Therapy News 11.24, June 28, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  |  Unsubscribe

TOP STORY


Genetic Septet in Control of Blood Platelet Clotting
In what is believed to be the largest review of the human genetic code to determine why some people’s blood platelets are more likely to clump faster than others, scientists have found a septet of overactive genes, which they say likely control that bodily function. [Press release from Johns Hopkins Medicine discussing online prepublication in Nature Genetics]

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SCIENCE NEWS


Twelve New Genes Linked to Type 2 Diabetes
Twelve new genes associated with type 2 diabetes have been identified in the largest study yet of the connections between differences in people’s DNA and their risk of diabetes. [Press release the University of Oxford discussing online prepublication in Nature Genetics]

Virus Works with Gene to Cause Crohn's-Like Illness
Scientists have shown that a specific virus can interact with a mutation in the host's genes to trigger disease. The observation may help explain why many people with disease risk genes do not actually develop disease. [Press release from Washington University School of Medicine discussing online prepublication in Cell]

Scientists Implant Regenerated Lung Tissue in Rats
Scientists report that they have achieved an important first step in regenerating fully functional lung tissue that can exchange gas. [Press release from Yale University discussing online prepublication in Science]

Living, Breathing Human Lung-on-a-Chip: A Potential Drug-Testing Alternative
Researchers have created a device that mimics a living, breathing human lung on a microchip. [Press release from the Wyss Institute for Biologically Inspired Engineering at Harvard University discussing online prepublication in Science]

Microbial Protein Restores Vision in Blind Animals
Neurobiologists have devised a gene therapeutic method to restore the functionality of the cone cells in models of retinitis pigmentosa. They used a light-sensitive protein called halorhodopsin from archaebacteria to re-establish vision. [Press release from the Friedrich Miescher Institute for Biomedical Research discussing online prepublication in Science]

Researchers Create Self-Assembling Nanodevices That Move and Change Shape on Demand
By emulating nature's design principles, researchers have created nanodevices made of DNA that self-assemble and can be programmed to move and change shape on demand. [Press release from the Wyss Institute for Biologically Inspired Engineering discussing online prepublication in Nature Nanotechnology]

Studying Cells in 3D Could Reveal New Cancer Targets
A new study indicates that viewing cell behavior in three dimensions could lead to important advances in cancer research. [Press release from Johns Hopkins University discussing online prepublication in Nature Cell Biology]

New Lung Cancer Treatment Is Saving Lives
Chemotherapy given after surgery for lung cancer improves overall survival rates in the general population. [Press release from Queen’s University discussing online prepublication in the Journal of Clinical Oncology]

Molecular Discovery Suggests New Strategy to Fight Cancer Drug Resistance
Scientists have found a way to disable a common protein that often thwarts chemotherapy treatment of several major forms of cancer. [Press release from Dana-Farber Cancer Institute discussing online prepublication in Nature Chemical Biology]

Gene Linked to Blood Clots During Cancer Therapy
A new study has found a gene mutation that can increase the risk of developing blood clots in breast cancer patients undergoing treatment with the drug tamoxifen. [Press release from BioNews discussing research published in the Journal of the National Cancer Institute]

Scientists Capture Structure of Virus Changing During Infection
Using intricate scientific techniques that involved freezing bacteria and virus and transporting in liquid nitrogen, scientists used powerful cryo-electron microscopes to determine how the structure of the virus changes during infection, allowing it to release its DNA into the cell. [Press release from the Baylor College of Medicine discussing online prepublication in Nature Structural and Molecular Biology]

Control of Cancer Cell Pathways Key to Halting Disease Spread
Scientists have deciphered a part of the pathway used by the oncogene called Myc to exert its malignant effect. Their findings confirm that at least some cancerous cells have within them the seeds to stop their own growth, if Myc can first be disabled. [Press release from Stanford University School of Medicine discussing online prepublication in Genes and Development]

Multinational Research Team Sequences Body Louse Genome
A global research team published a new study describing the sequencing and analysis of the body louse genome. [Press release from the J. Craig Venter Institute discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

Brain Scans Support Genes' Role in Alzheimer's Disease
Scientists have confirmed that four suspect genes are tied to Alzheimer’s disease and linked the disease to two new genes, offering unexpected targets for future research. [Press release from the National Institutes of Health discussing online prepublication in the Archives of Neurology]

Inovio Pharmaceuticals' Optimized DNA Vaccine Demonstrates Significant Advantages in Non-Human Primates Compared to Leading Viral Vector Based Vaccine
Researchers noted that significant advances in the design, formulation, and delivery of DNA plasmid-based vaccines have dramatically increased their ability to induce antigen-specific immune responses. [Press release from Inovio Pharmaceuticals, Inc. discussing online prepublication in Molecular Therapy]

CEL-SCI Collaborator Presents Data Showing LEAPS™ Vaccine Technology Generates Dendritic Cells That Can Protect Animals Against Viral Illness and Other Diseases
CEL-SCI Corporation and researchers at the Northeastern Ohio Universities Colleges of Medicine and Pharmacy jointly announced that a LEAPS™-based vaccine (Ligand Epitope Antigen Presentation System) study has demonstrated the technology's potential using dendritic cells to stimulate the immune system to fight viral illnesses and other diseases. [Press release from CEL-SCI Corporation discussing online prepublication in Vaccine]

University of Texas Medical Branch Grows Lung from ‘Skeletons’
Specialists in the field of tissue engineering have been frustrated by the problem of coaxing undifferentiated stem cells to develop into the specific cell types that populate different locations in the lung. Now, researchers have demonstrated a potentially revolutionary solution to this problem. [Press release from the University of Texas Medical Branch discussing online prepublication in Tissue Engineering Part A]

Identification of a Novel Tumor Suppressor
Scientists have identified a novel tumor suppressor playing an important role in T-cell lymphoma. The protein kinase NDR1 has so far been implicated in the processes controlling cell death and centrosome duplication. [Press release from the Friedrich Miescher Institute for Biomedical Research discussing online prepublication in Science Signaling]

Building a Substitute Pancreas for Diabetics
Implants containing specially wrapped insulin-producing cells derived from embryonic stem cells can regulate blood sugar in mice for several months. [Press release from MIT Technology Review discussing research presented at the 8th Annual Meeting of the International Society for Stem Cell Research]

Scientists Successfully Engineer Heart Tissue
Scientists in China have successfully engineered myocardial tissue that is likely to share structural and functional similarities with natural myocardium. [Press release from the World Heart Federation discussing research presented at the World Congress of Cardiology 2010]

Stem Cells Offer Hope in Cerebral Palsy Battle
Researchers have begun a U.S. Food and Drug Administration-authorized random clinical trial to see if cord blood stem cells have the ability to cure or lessen spastic cerebral palsy in children aged 1 to 6. [Triangle Business Journal]

Gene Therapy a Step Closer to Mass Production
Researchers have synthesized and studied a range of organic compounds able to carry genetic material into individual cells where it can remedy the diseases caused by defective genes. Still under development, these compounds are much more readily produced than the viral carriers now in use and avoid their side-effects. [EUREKA Network Press Release]

Neurologix Announces Successful Phase II Trial of Gene Therapy for Parkinson's Disease
Neurologix, Inc. announced positive results in a Phase II trial of its investigational gene therapy for advanced Parkinson's disease, NLX-P101. [Neurologix, Inc. Press Release]

Cellonis Diabetes Stem Cell Therapy: A Chance for Insulin Independence and the Reversal of Complications
A new personalized diabetes treatment concept has demonstrated an amazing improvement in treated patients’ conditions. The ongoing clinical study shows the treatment’s best case could reconstruct a patient’s natural insulin production and even reverse later complications like kidney failure. [Cellonis Press Release]

Mologen AG Receives Approval for Clinical Study with Cell-Based Gene Therapy Against Renal Cancer
Mologen AG has received approval from the Paul-Ehrlich-Institut to carry out a Phase I/II clinical study with its innovative new MGN1601 cancer medicine. MGN1601 is a cell-based gene therapy for the treatment of advanced renal cancer. [Mologen Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Limbal Stem-Cell Therapy and Long-Term Corneal Regeneration
Cultures of limbal stem cells represent a source of cells for transplantation in the treatment of destruction of the human cornea due to burns. [N Engl J Med]

Genome-Wide Meta-Analyses Identifies Seven Loci Associated with Platelet Aggregation in Response to Agonists
Researchers identified associations of seven loci with platelet aggregation near or within GP6, PEAR1, ADRA2A, PIK3CG, JMJD1C, MRVI1 and SHH. [Nat Genet]

Twelve Type 2 Diabetes Susceptibility Loci Identified Through Large-Scale Association Analysis
By combining genome-wide association data from 8,130 individuals with type 2 diabetes (T2D) and 38,987 controls of European descent and following up previously unidentified meta-analysis signals in a further 34,412 cases and 59,925 controls, researchers identified 12 new T2D association signals. [Nat Genet]

Virus-Plus-Susceptibility Gene Interaction Determines Crohn's Disease Gene Atg16L1 Phenotypes in Intestine
Researchers provide a specific example of how a virus-plus-susceptibility gene interaction can, in combination with additional environmental factors and commensal bacteria, determine the phenotype of hosts carrying common risk alleles for inflammatory disease. [Cell]

Tissue-Engineered Lungs for In Vivo Implantation
To explore whether lung tissue can be regenerated in vitro, researchers treated lungs from adult rats using a procedure that removes cellular components but leaves behind a scaffold of extracellular matrix that retains the hierarchical branching structures of airways and vasculature. [Science]

Reconstituting Organ-Level Lung Functions on a Chip
Researchers describe a biomimetic microsystem that reconstitutes the critical functional alveolar-capillary interface of the human lung. [Science]

Genetic Reactivation of Cone Photoreceptors Restores Visual Responses in Retinitis Pigmentosa
Researchers show that expression of archaebacterial halorhodopsin in light-insensitive cones can substitute for the native phototransduction cascade and restore their light sensitivity in mouse models of retinitis pigmentosa. [Science]

Self-Assembly of Three-Dimensional Prestressed Tensegrity Structures from DNA
Researchers report nanoscale, prestressed, three-dimensional tensegrity structures in which rigid bundles of DNA double helices resist compressive forces exerted by segments of single-stranded DNA that act as tension-bearing cables. [Nat Nanotechnol]

The MCL-1 BH3 Helix Is an Exclusive MCL-1 Inhibitor and Apoptosis Sensitizer
By leveraging nature's solution to ligand selectivity, researchers generated an MCL-1–specific agent that defines the structural and functional features of targeted MCL-1 inhibition. [Nat Chem Biol]

Structural Changes in a Marine Podovirus Associated with Release of Its Genome into Prochlorococcus
Observations suggest a mechanism whereby, upon binding to the host cell, the tail fibers induce a cascade of structural alterations of the portal vertex complex that triggers DNA release. [Nat Struct Mol Biol]

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POLICY


President of EFPIA Calls for a ‘New Dialogue’ on Medicines
Andrew Witty, CEO of GlaxoSmithKline and President of European Federation of Pharmaceutical Industries and Associations (EFPIA), the body representing the research-based pharmaceutical industry in Europe, called for ‘a new dialogue’ between governments and the pharmaceutical industry in order to deliver patient access to better medicines and enhance Europe’s competitiveness as a base for R&D investment. [European Federation of Pharmaceutical Industries and Associations, European Union]

Public Wants Synthetic Biology Regulated, Survey Says
According to the most extensive public survey yet, the British public are at ease with the idea of synthetic biology — but only if it is responsibly regulated. [Biotechnology and Biological Sciences Research Council, United Kingdom]

FDA Told to Step Up Oversight of Offshore Clinical Trials
The Food and Drug Administration (FDA) hasn't done enough to monitor clinical trial data coming from overseas sites and patients, which increasingly dominate the studies used to support U.S. drug applications, according to a report from the Department of Health and Human Services' inspector general. [Department of Health and Human Services, United States]

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BUSINESS


Gamida Cell-Teva Joint Venture Receives FDA Fast Track Designation for StemEx® for Leukemia and Lymphoma
Gamida Cell announced that the Gamida Cell-Teva Joint Venture has received a Food and Drug Administration (FDA) Fast Track Designation for StemEx, in development as an alternative to a bone marrow transplant for patients with blood cancers such as leukemia and lymphoma. [Gamida Cell Press Release]

Sanofi-Aventis and Regulus Therapeutics Form Major Strategic Alliance on microRNA Therapeutics
Regulus Therapeutics Inc. and Sanofi-Aventis announced that they have entered into a global, strategic alliance to discover, develop, and commercialize microRNA therapeutics. [Regulus Therapeutics Inc. Press Release]

Valeant and Biovail Agree to Merge
Valeant and Biovail announced that both companies' Boards of Directors have unanimously approved a definitive merger agreement under which the companies would combine to generate enhanced value for stockholders. The combined company will be called Valeant Pharmaceuticals International, Inc. [Biovail Corporation Press Release]

AGTC and Icagen Announce Technology Transfer Agreement
AGTC and Icagen, Inc. announced the completion of an agreement for the purchase and sale of certain patent rights between the companies. [Icagen, Inc. Press Release]

ImmunoCellular Therapeutics Announces Licensing Agreement with Targepeutics for Worldwide Intellectual Property Rights to Validated Immunotherapy Target
ImmunoCellular Therapeutics, Ltd. announced it has entered into an exclusive licensing agreement with Targepeutics, Inc. for ImmunoCellular’s acquisition of Targepeutics’ worldwide intellectual property rights surrounding the IL-13 receptor, alpha 2. [ImmunoCellular Therapeutics, Ltd. Press Release]

AstraZeneca and MMV Join Efforts in the Fight Against Malaria
AstraZeneca and Medicines for Malaria Venture (MMV) announced a collaborative agreement designed to identify novel candidate drugs for the treatment of malaria. [AstraZeneca Press Release]

CIRM Allocates $25 Million to Overcome Immune Rejection of Stem Cell Transplantation Therapies
The Governing Board of the California Institute for Regenerative Medicine (CIRM) approved $25 million to fund 19 projects intended to overcome immune rejection of transplanted stem cells. [California Institute for Regenerative Medicine Press Release]

$5.6 Million Awarded for Stem Cell Research at Stanford
Four researchers from the Stanford University School of Medicine were awarded about $5.6 million from the California Institute for Regenerative Medicine to study how to overcome the immune rejection of cells and tissues derived from stem cells. [Stanford University School of Medicine press Release]

SEK 100 Million for Research into Regenerative Medicine
Karolinska Institutet has received a grant of SEK 100 million from the Knut and Alice Wallenberg Foundation for a regenerative medicine research centre – the Wallenberg Institute for Regenerative Medicine. [Karolinska Institutet Press Release]

London's 'Somewhat Unusual' New Research Centre
Britain plans a £600-million biomedical facility for young investigators, the UK Centre for Medical Research and Innovation. [NatureNews]

t2cure’s Cellular Therapeutic Receives Orphan Drug Designation
t2cure GmbH announced that the Food and Drug Administration has granted orphan drug designation to t2c001 for the treatment of Buerger’s Disease. [t2cure GmbH Press Release]

FDA Approves First-of-Its-Kind HIV Test Which Can Detect HIV Days Earlier Than Current U.S. Tests
Abbott's ARCHITECT HIV Ag/Ab Combo assay is the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies. [Abbott Laboratories Press Release]

Pluristem is Advancing Toward Two Phase IIb Clinical Trials for Treatment of Critical Limb Ischemia and Moderate-Severe Claudication
Pluristem Therapeuitcs Inc. announced that following its meeting with the Paul Ehrlich Institute, the German regulatory authority for advanced therapy products, the company is advancing toward designing two Phase IIb clinical trials for its placenta-derived cell therapy product, PLX-PAD, for the treatment of Critical Limb Ischemia and Moderate-severe Claudication. [Pluristem Therapeuitcs Inc. Press Release]

Radient Phamacueticals Strategic Partner Jaiva Technologies Plans to Submit Application for Phase II Human Clinical Trials for Non-Small Cell Lung Carcinoma
Radient Pharmaceuticals Corporation (RPC) and Jaiva Technologies, Inc. announced that Jaiva plans to submit a clinical trial application to the Central Drugs Standard Control Organization in India to commence human Phase II trials for RPC’s Combination Immunogene Therapy technology as a vaccine therapy for non-small cell lung carcinoma. [Radient Pharmaceuticals Corporation Press Release]

Cheryl Moore Named HHMI’s First Chief Operating Officer
Robert Tjian, president of the Howard Hughes Medical Institute, announced the appointment of Cheryl A. Moore as the Institute’s first chief operating officer. [Howard Hughes Medical Institute Press Release]




NIH


National Heart, Lung, and Blood Institute Funds Research to Improve Safety of Red Blood Cell Transfusions
The National Heart, Lung, and Blood Institute is funding nine research grants to determine if the safety and efficacy of red blood cell transfusions vary depending on how long the cells have been stored.

NIBIB and the Indian Department of Biotechnology Collaborate to Develop Low-Cost Medical Devices
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced the availability of supplemental funding for eligible NIBIB-supported research grants to facilitate collaborative work among researchers in the United States and India.

Center for Scientific Review; Notice of Closed Meetings

Amendment: PAR-09-103: Centers for AIDS Research and Developmental Centers for AIDS Research (P30) (NOT-AI-10-033)

Extension of Expiration Date and Additional Receipt Dates for RFA-AI-10-014: Ancillary Studies in Immunomodulation Clinical Trials (R01) (NOT-AI-10-035)

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CBER


Development of Articles for Rare Diseases
On Tuesday, June 29, 2010, and Wednesday, June 30, 2010, FDA's Office of Orphan Products Development will host a two-day public hearing and webcast on the Development of Articles for Rare Diseases.

July 26-27, 2010: Meeting of the Blood Products Advisory Committee Announcement


REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

Implementation of the Biologics Price Competition and Innovation Act of 2009

FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests

Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases, Public Workshop; July 26-27, 2010

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

The 7th Annual TOPRA (The Organization for Professionals in Regulatory Affairs) Symposium
This annual symposium is for all those involved within regulatory affairs and brings together representatives of industry and the regulatory agencies and the European Commission to discuss and understand today’s regulatory issues and debate the future plans for regulation.

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Therapeutic Goods Administration – New Structural Arrangements
The Therapeutic Goods Administration will officially launch a new organisational structure on 1 July 2010.


EVENTS

16th Annual Meeting of the Japan Society of Gene Therapy (JSGT)
July 1-3, 2010
Utsunomiya City, Japan

Worldwide Innovative Networking (WIN) Symposium in Personalized Cancer Medicine
July 7-9, 2010
Paris, France

Translational Cancer Medicine 2010 – USA
July 11-14, 2010
San Francisco, United States

United Kingdom National Stem Cell Network (UKNSCN) Annual Scientific Conference
July 12-14, 2010
Nottingham, United Kingdom

2nd International Conference on Cellular and Molecular Bioengineering (ICCMB2)
August 2-4, 2010
Singapore City, Singapore

CHI's 5th Annual Immunotherapeutics and Vaccine Summit (ImVacS)
August 17-19, 2010
Cambridge, United States

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

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

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

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

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

Translational Cancer Research for Basic Scientists
October 17-22, 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

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

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

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

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

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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