Volume 11.20 | May 31

Cell Therapy News 11.20, May 31, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  |  Unsubscribe


TOP STORY


Blocking Tumor's “Death Switch” Paradoxically Stops Tumor Growth
According to a new research study, a receptor thought to mediate cell suicide in normal cells may actually be responsible for the unrestrained growth of cancerous tumors. [Press release from the University of Chicago Medical Center discussing online prepublication in Nature]

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SCIENCE NEWS


Mental Illness Tied to Immune Defect — Bone Marrow Transplants Cure Mice of Hair-Pulling Compulsion
A geneticist discovered that bone marrow transplants cure mutant mice who pull out their hair compulsively. The study provides the first cause-and-effect link between immune system cells and mental illness, and points toward eventual new psychiatric treatments. [Press release from the University of Utah discussing online prepublication in Cell]

Tekmira Reports Complete Protection from Deadly Ebola Virus in Nonhuman Primates with SNALP-RNAi
Tekmira Pharmaceuticals Corporation announced the publication of a series of studies demonstrating the ability of an RNAi therapeutic utilizing Tekmira’s lipid nanoparticle technology, SNALP, to protect nonhuman primates from Ebola virus. [Press release from Tekmira Pharmaceuticals Corporation discussing online prepublication in Lancet]

Novel RNA Interference Screening Technique Identifies Possible Path for Malignant Glioma Treatment
Researchers report a cellular pathway in the deadly brain cancer malignant glioma, a pathway essential to the cancer’s ability to grow – and a potential target for therapy that would stop the cancer’s ability to thrive. [Press release from the University of Massachusetts Medical School discussing online prepublication in Nature Medicine]

Gene Fusions May Be the ‘Smoking Gun’ in Prostate Cancer Development
The study suggests that the gene fusion – not the androgen receptor – is a more specific “bad actor” in prostate cancer and is the real smoking gun that should be targeted by treatments. [Press release from the University of Michigan Comprehensive Cancer Center discussing online prepublication in Cancer Cell]

Transplant Tolerance 'Signature' Identified
Researchers have identified a ‘full set’ of immunological markers in the blood, which could be used to predict whether an individual’s kidney transplant will be a long term success or whether it will fail. [Press release from King’s College London discussing online prepublication in the Journal of Clinical Investigation]

Gene Pattern May Identify Kidney Transplant Recipients Who Don’t Need Life-Long Anti-Rejection Drugs
Researchers have identified a distinct pattern of gene expression in the largest reported group of kidney transplant recipients who have not rejected the transplant kidneys even though they stopped taking anti-rejection drugs. [Press release from the National Institutes of Health discussing online prepublication in the Journal of Clinical Investigation]

Novel Stem Cells Could Offer Myocardial Infarct Therapy
Stem cells derived from the human amniotic sac can become beating heart muscle cells, at least in rats, researchers said, offering the possibility of off-the-shelf stem cell therapy for heart attacks. [Press release from MedPage Today discussing online prepublication in Circulation Research]

To Attack H1N1, Other Flu Viruses, Gold Nanorods Deliver Potent Payload
Future pandemics of seasonal flu, H1N1 and other drug-resistant viruses may be thwarted by a potent, immune-boosting payload that is effectively delivered to cells by gold nanorods. [Press release from the University at Buffalo discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

Rare Hybrid Cell Key to Regulating the Immune System
A cell small in number but powerful in its ability to switch the immune system on or off is a unique hybrid of two well-known immune cell types, researchers report. [Press release from the University of Georgia discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

Novel Therapeutic Approach Shows Promise Against Multiple Bacterial Pathogens
Researchers combined components isolated from the membrane of a weakened strain of Francisella tularensis, the agent of tularemia, with the Juvaris product CLDC (cationic liposome DNA complexes). The combination stimulated a natural antibacterial mechanism, reactive oxygen species (ROS) and reactive nitrogen species, in immune cells that ingest bacteria. [Press release from the National Institute of Allergy and Infectious Diseases discussing online prepublication in PLoS Pathogens]

Retina Created from Human Stem Cells
Scientists have created an eight-layer, early-stage retina from human embryonic stem cells, the first three-dimensional tissue structure to be made from stem cells. [Press release from the University of California, Irvine discussing online prepublication in the Journal of Neuroscience Methods]

Suicide Genes May Improve Safety of Stem Cell Therapies
Cells programmed to commit immediate suicide may increase the safety of cell therapy treatments for patients with cancer and other diseases. [American Society of Gene & Cell Therapy Press Release]

Gene Therapy Reverses Muscle Weakness in Muscular Dystrophy Patients
In a small study, patients with limb-girdle muscular dystrophy received a transplant of healthy genes. After six months, a majority of patients showed increased levels of muscle fiber and gene expression similar to those in healthy patients with normal muscle control. [American Society of Gene & Cell Therapy Press Release]

Chemotherapy Ups Odds for Success in Treating “Bubble Boy” Disease
Gene therapy combined with chemotherapy may lead to immune system improvement in patients with bubble boy disease. [American Society of Gene & Cell Therapy Press Release]

DNA Vaccine Eases Treatment of Hepatitis C
A vaccine that delivers corrected DNA to the immune system may hold the cure for hepatitis C, according to results of a first-of-its-kind study. [American Society of Gene & Cell Therapy Press Release]

IV Is Key for Treatment of Advanced Cancers
Intravenous (IV) delivery of a cancer-targeting virus is successful in destroying cancer cells that have spread throughout the body. [American Society of Gene & Cell Therapy Press Release]

Amsterdam Molecular Therapeutics Reports Promising Data from Cholesterol Lowering Gene Therapy Study
Amsterdam Molecular Therapeutics reported positive preclinical data from a study using an AAV gene therapy product to lower cholesterol. [Press release from Amsterdam Molecular Therapeutics discussing research presented at the 13th Annual American Society of Gene & Cell Therapy Meeting]

Targeted Immunotherapy Shows Promise in Penn Medicine Studies for Metastatic Breast and Pancreatic Cancers
Early trials using targeted monoclonal antibodies in combination with existing therapies show promise in treating pancreatic cancer and metastatic breast cancer. [Press release from the University of Pennsylvania School of Medicine discussing research to be presented at the 2010 American Society of Clinical Oncology Annual Meeting]

Gene Therapy May Be Effective in Treating PAH
Gene therapy has been shown to have positive effects in rat models of pulmonary arterial hypertension (PAH), according to researchers at the University of Adelaide in Australia. [Press release from EurekAlert! discussing research presented at the American Thoracic Society 2010 International Conference]

Mouse Project to Find Each Gene's Role
An ambitious effort by the International Mouse Phenotyping Consortium to identify the function of every gene in the mouse genome looks set to provide scientists with the ultimate mouse model of human disease. [Nature News]

Researchers Successfully Culture Liver Stem Cells Outside the Body for the First Time
A research team at the National Cancer Center is the world's first to successfully stabilize and culture liver stem cells outside the body. [Press release from The Mainichi Daily News]

Phase II Clinical Trial Data Show Significant Improvements in Outcomes and Symptoms in Advanced Heart Failure Patients Treated with Celladon’s Genetically Targeted Enzyme Replacement Therapy MYDICAR®
Celladon Corp. announced that six-month data from its Phase II clinical trial of MYDICAR® show improvements in clinical outcomes and disease markers in advanced heart failure patients treated with the genetically targeted enzyme replacement therapy. [Celladon Corporation Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

CD95 Promotes Tumor Growth
The results demonstrate that CD95 has a growth-promoting role during tumorigenesis and indicate that efforts to inhibit its activity rather than to enhance it should be considered during cancer therapy. [Nature]

Hematopoietic Origin of Pathological Grooming in Hoxb8 Mutant Mice
It has been suggested that the grooming dysfunction results from a nociceptive defect, also exhibited by Hoxb8 mutant mice. However, bone marrow transplant experiments and cell type-specific disruption of Hoxb8 reveal that these two phenotypes are separable, with the grooming phenotype derived from the hematopoietic lineage and the sensory defect derived from the spinal cord cells. [Cell]

A Genome-Wide RNA Interference Screen Reveals an Essential CREB3L2-ATF5-MCL1 Survival Pathway in Malignant Glioma with Therapeutic Implications
The results reveal an essential survival pathway in malignant glioma, whereby activation of a RAS–mitogen-activated protein kinase or phosphoinositide-3-kinase signaling cascade leads to induction of the transcription factor cAMP response element–binding protein-3–like-2 (CREB3L2), which directly activates ATF5 expression. ATF5, in turn, promotes survival by stimulating transcription of myeloid cell leukemia sequence-1 (MCL1), an antiapoptotic B cell leukemia-2 family member. [Nat Med]

An Autoimmune-Mediated Strategy for Prophylactic Breast Cancer Vaccination
Researchers found that immunoreactivity against alpha-lactalbumin provides substantial protection and therapy against growth of autochthonous tumors in transgenic mouse models of breast cancer and against 4T1 transplantable breast tumors in BALB/c mice. [Nat Med]

An Integrated Network of Androgen Receptor, Polycomb, and TMPRSS2-ERG Gene Fusions in Prostate Cancer Progression
The findings provide a working model in which TMPRSS2-ERG plays a critical role in cancer progression by disrupting lineage-specific differentiation of the prostate and potentiating the EZH2-mediated dedifferentiation program. [Cancer Cell]

Identification of a B Cell Signature Associated with Renal Transplant Tolerance in Humans
The results point to a critical role for B cells in regulating alloimmunity and provide a candidate set of genes for wider-scale screening of renal transplant recipients. [J Clin Invest]

Xenografted Human Amniotic Membrane–Derived Mesenchymal Stem Cells Are Immunologically Tolerated and Transdifferentiated into Cardiomyocytes
Because human amniotic membrane–derived mesenchymal cells have a high ability to transdifferentiate into cardiomyocytes and to acquire immunologic tolerance in vivo, they can be a promising cellular source for allograftable stem cells for cardiac regenerative medicine. [Circ Res]

Gold Nanorod Delivery of an ssRNA Immune Activator Inhibits Pandemic H1N1 Influenza Viral Replication
Researchers introduce a nanotechnology approach for the therapy of pandemic and seasonal influenza virus infections, which uses gold nanorods to deliver an innate immune activator, producing a localized therapeutic response. [Proc Natl Acad Sci U S A]

B-Lymphoid Cells with Attributes of Dendritic Cells Regulate T Cells via Indoleamine 2,3-Dioxygenase
Researchers show that indoleamine 2,3-dioxygenase-competent cells express the B-lineage commitment factor Pax5 and surface immunoglobulins. [Proc Natl Acad Sci U S A]

Effective, Broad Spectrum Control of Virulent Bacterial Infections Using Cationic DNA Liposome Complexes Combined with Bacterial Antigens
Development of novel, immunomodulatory prophylaxes that target the host immune system, rather than the invading microbe, could serve as effective alternatives to traditional chemotherapies. Researchers describe the development and mechanism of a novel pan-anti-bacterial prophylaxis. [PLoS Pathog]

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POLICY


Third Time's a Charm for COMPETES Bill
By a vote of 262 to 150, legislators authorized $84 billion for research, education, and innovation programs over the next 5 years at the National Science Foundation, the Department of Energy, and two Department of Commerce agencies—NOAA and NIST under the America COMPETES Reauthorization Act (HR 5116). [House of Representatives, United States]

Democrats: FDA Should Be Able to Recall Drugs
House Democrats repeatedly called for federal regulators to be given the authority to recall drugs.
Pending legislation would grant that power to the Food and Drug Administration (FDA) for food, but not for drugs. [House of Representatives, United States]

Congress Considers Synthetic Biology Risks, Benefits
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the government is moving quickly to bring synthetic biology under review by two existing panels that have done a good job of monitoring cutting-edge research in the past. [U.S. House of Representatives Committee on Energy and Commerce, United States]

Last Hurrah from National Academies Stem Cell Committee
Even though the National Institutes of Health issued stem cell guidelines last year, there's still a need for guidelines for research that remains off-limits for U.S. government-funded labs. [National Academies' National Research Council and Institute of Medicine, United States]

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BUSINESS


The Pontifical Council for Culture and NeoStem Partner to Advance Adult Stem Cell Research
Reverend Tomasz Trafny of the Vatican's Pontifical Council for Culture announced what he characterized as the Vatican's first-ever contractual collaboration with an outside commercial venture to advance stem cell research – adult stem cell research. [NeoStem, Inc. Press Release]

Harnessing the Power of Stem Cells to Unlock the Secrets of Motor Neuron Disease
The Motor Neurone Disease Association is funding its first ever stem cell research programme to help unlock the secrets of this fatal, neurological condition. [Motor Neurone Disease Association Press Release]

Biomedical Structures Receives Growth Capital from Ampersand Ventures to Fund Ongoing Expansion
Biomedical Structures LLC, a leading supplier of custom-designed biomaterials and textiles used in advanced clinical applications from orthopedics and reconstructive surgery to tissue engineering, announced that it has completed a private equity financing with Ampersand Ventures. [PR Newswire]

t2cure First Company to Have Quality of Cellular Therapeutic Certified by EMA
t2cure GmbH announced that the quality of its lead product t2c001 has been certified by the European Medicines Agency (EMA). t2c001 is the first product ever to obtain a certificate under the EMA regulations for Advanced Therapy Medicinal Products. [t2cure GmbH Press Release]

BioTime Adds Five New Stem Cell Lines to Its Product Portfolio
BioTime, Inc. announced that on June 1, 2010 the Company will be offering for sale five new human stem cell lines for research use only. [Yahoo! Finance]

Vaxon Biotech Successfully Completes Its Phase I/II Trial of Vx-001 Cancer Vaccine, Phase III Ready to Start in Non-Small Cell Lung Cancer
Vaxon Biotech, a specialist in tumor immunotherapy, announced the successful conclusion of the Phase I/II trial of its Vx-001 therapeutic cancer vaccine. [Vaxon Biotech Press Release]

Allen Institute for Brain Science Launches Allen Human Brain Atlas with First Data Set Charting Genes at Work in the Adult Human Brain
The Allen Institute for Brain Science announced that it has launched the Allen Human Brain Atlas, a publicly available online atlas charting genes at work throughout the human brain. [The Allen Institute for Brain Science Press Release]

Glaxo Tries a Linux Approach
A move by GlaxoSmithKline PLC could test how well open-source principles work for developing new drugs. The pharmaceutical giant opened to the public the designs behind 13,500 chemical compounds that it said may be capable of inhibiting the parasite that causes malaria. [The Wall Street Journal]

Bioheart Announces Cell Therapies Program in the Middle East for Congestive Heart Failure and Peripheral Arterial Disease Patients
Bioheart, Inc. announced plans for establishing two Centers of Excellence in the Middle East to provide its cell therapy procedures to patients suffering from congestive heart failure and peripheral arterial disease. [PR Newswire]

DFG Approves 12 New Collaborative Research Centers
The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) has approved the establishment of twelve new Collaborative Research Centers. [Dutch Research Foundation Press Release]




NIH


NIH Set to Tighten Financial Rules for Researchers
After a wave of financial scandals over the past few years involving biomedical researchers, the U.S. National Institutes of Health (NIH) proposed far-reaching changes that would lead to tighter oversight of agency-funded extramural investigators and their institutions. [National Institutes of Health, United States]

Request for Information (RFI) on the NIH Plan to Develop the Genetic Testing Registry (NOT-OD-10-101)

Administrative Supplements to Advance Special Translational Research Acceleration Projects on Immune Response Modifiers Currently Funded by the National Cancer Institute (NCI) (NOT-CA-10-025)

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REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

Possible Fracture Risk with High Dose, Long-Term Use of Proton Pump Inhibitors
The U.S. Food and Drug Administration warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of proton pump inhibitors.




EVENTS


Stem Cell Investor & Executive Networking Conference Event (S.C.I.E.N.C.E.)
June 1, 2010
New York, United States

Second Annual Consumer Genetics Conference
June 2-4, 2010
Boston, United States

The Future of Molecular Epidemiology: New Tools, Biomarkers, and Opportunities
June 6-9, 2010
Miami, United States

Select Biosciences 3rd Annual Cancer Proteomics Conference
June 8-9, 2010
Berlin, Germany

Select Biosciences Inaugural Advances in Antibody and Peptide Therapeutics
June 8-9, 2010
Berlin, Germany

Regenerative Medicine in 21st Century: Managing Uncertainty at the Global Level Conference
June 9-10, 2010
Madison, United States

8th International Conference on Cell and Stem Cell Engineering
June 11-12, 2010
Dublin, Ireland

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – European Union 2010
June 13-17, 2010
Galway, Ireland

The First Cedars-Sinai Regenerative Medicine Scientific Symposium
June 14, 2010
Los Angeles, United States

International Society for Stem Cell Research (ISSCR) 8th Annual Meeting
June 16-19, 2010
San Francisco, United States

Accelerating Anticancer Agent Development and Validation
June 23-25, 2010
North Bethesda, United States

XXXIst International Congress of the International Society of Blood Transfusion (ISBT) in joint cooperation with the 43rd Congress of the German Society for Transfusion Medicine and Immunohematology (DGTI)
June 26-July 1, 2010
Berlin, Germany

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

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

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

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

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

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

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

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

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


 

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