Volume 12.18 | May 9

Cell Therapy News 12.18, May 9, 2011
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
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TOP STORIES
Columbia Engineers Patch A Heart
Researchers have established a new method to patch a damaged heart using a tissue-engineering platform that enables heart tissue to repair itself. [Press release from Columbia University School of Engineering discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

CIRM Awards $25 Million to Support Spinal Cord Injury Trial, $37.7 Million for Basic Stem Cell Science
The Governing Board of the California Institute for Regenerative Medicine (CIRM) approved a $25 million award to support the first FDA-approved clinical trial based on cells derived from human embryonic stem cells. The award to Menlo Park-based Geron, Corp, will support the company’s on-going early phase trial for people with spinal cord injury. [California Institute for Regenerative Medicine Press Release]

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SCIENCE NEWS

Cells Derived from Different Stem Cells: Same or Different?
A team of researchers has now determined that mouse induced pluripotent stem and parental embryonic stem cells show highly similar capacity to be differentiated in vitro into definitive endoderm progenitors. [Press release from EurekAlert! discussing online prepublication in the Journal of Clinical Investigation]

Hitting Target in Cancer Fight Now Easier with New Nanoparticle Platform, Scientists Say
Scientists report that by using engineered mesoporous silica nanoparticles as delivery vehicles, they were able to achieve significant increases in the percentage of drug-carrying nanoparticles that reach and are retained at tumor sites. [Press release from the University of California, Los Angeles discussing online prepublication in ACS Nano]

Researchers Demonstrate Power of miRview™ Mets to Identify Tissue of Origin in Carcinoma of Unknown Primary
Rosetta Genomics, Ltd. announces that results of a joint study with researchers at the University of Texas, M. D. Anderson Cancer Center show that Rosetta Genomics’ miRview™ mets is a powerful tool to identify Tissue of Origin in Carcinoma of Unknown Primary (CUP) patients. [Press release from Rosetta Genomics, Ltd. discussing online prepublication in Clinical Cancer Research]

Researchers Discover Protein That Could Help Prevent the Spread of Cancer
A protein capable of halting the spread of breast cancer cells could lead to a therapy for preventing or limiting the spread of the disease. [Press release from Queen’s University discussing online prepublication in the Journal of Cell Science]

‘I’m a Tumor and I’m Over Here!’ Nanovaults Used to Prod Immune System to Fight Cancer
Scientists have discovered a way to “wake up” the immune system to fight cancer by delivering an immune system–stimulating protein in a nanoscale container called a vault directly into lung cancer tumors. [Press release from the University of California, Los Angeles discussing online prepublication in PLoS One]

Antibodies Help Protect Monkeys from HIV-Like Virus, NIH Scientists Show
Using a monkey model of AIDS, scientists have identified a vaccine-generated immune-system response that correlates with protection against infection by the monkey version of HIV, called simian immunodeficiency virus. [Press release from the National Institute of Allergy and Infectious Diseases discussing online prepublication in Science Translational Medicine]

Scientists Play Key Role in Success of Yervoy, a New Cancer Drug
Researchers and oncologists have played a key role in developing and testing immunotherapies that enhance the body’s own immune response. These include Yervoy – which releases the brakes that hold back the immune system from fighting cancer – and Provenge, which in 2010 became the first vaccine approved to treat any cancer. [University of California, San Francisco Press Release]

Extracting Stem Cells from Fat for Tissue Regeneration
An interdisciplinary team has been working with stem cells extracted from samples of human fat and is developing new methods in the lab to develop these cells into mature tissue substitutes. [Queen’s University Press Release]

Rutgers Offers Hope in New Treatment for Spinal Cord Injuries
Researchers have developed an innovative new treatment that could help minimize nerve damage in spinal cord injuries, promote tissue healing and minimize pain. [Rutgers Press Release]

Heart Cells Derived from Stem Cells Used to Study Heart Diseases
A research team is the first to use heart cells derived from stem cells to specifically study certain genetic mechanisms of heart diseases. [Press release from the University of Wisconsin School of Medicine and Public Health discussing research presented at the Annual Heart Rhythm Society Meeting]

Argos Therapeutics´ Immunotherapy Platform Based on Recombinant Human Soluble CD83 Demonstrates Significant Promise For Solid Organ Transplantation
Argos Therapeutics announced that its immunotherapy platform based on recombinant human soluble CD83 demonstrated significant promise for renal and heart transplantation. [Press release from Argos Therapeutics discussing research presented at the 2011 American Transplant Congress Meeting]

Childhood Cancer Researchers Work on a Novel Therapy for Lung Cancer
By targeting a structural protein in drug resistant lung cancer cells, scientists’ novel therapy for non-small lung cancer aims to increase the sensitivity of the tumor to standard chemotherapy drugs. It uses a gene-silencing approach to suppress this structural protein. [Press release from the Children’s Cancer Institute Australia discussing research presented at the Australasian Gene Therapy Society Meeting]

 
 
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CURRENT PUBLICATIONS
(Ranked by Impact Factor of the Journal)

Mouse ES and iPS Cells Can Form Similar Definitive Endoderm Despite Differences in Imprinted Genes
Scientists show that both mouse iPS and parental ES cells exhibited highly similar in vitro capacity to undergo directed differentiation into definitive endoderm progenitors. [J Clin Invest]

Composite Scaffold Provides a Cell Delivery Platform for Cardiovascular Repair
Researchers developed a method for complete decellularization of human myocardium that leaves intact most elements of the extracellular matrix, as well as the underlying mechanical properties. [Proc Natl Acad Sci U S A]

Use of Size and a Copolymer Design Feature to Improve the Biodistribution and the Enhanced Permeability and Retention Effect of Doxorubicin-Loaded Mesoporous Silica Nanoparticles in a Murine Xenograft Tumor Model
Investigators demonstrate that size reduction and surface functionalization of mesoporous silica nanoparticles (MSNP) with a polyethyleneimine–polyethylene glycol copolymer reduces particle opsonization while enhancing the passive delivery of monodispersed, 50 nm doxorubicin-laden MSNP to a human squamous carcinoma xenograft in nude mice after intravenous injection. [ACS Nano]

Prospective Gene Signature Study Using microRNA to Identify the Tissue of Origin in Patients with Carcinoma of Unknown Primary (CUP)
Scientists prospectively studied the performance of a microRNA-based assay to identify the tissue of origin in CUP patients. [Clin Cancer Res]

Cdc42-Interacting Protein 4 Is a Src Substrate That Regulates Invadopodia and Invasiveness of Breast Tumors by Promoting Transmembrane Type I Matrix Metalloprotease Endocytosis
Researchers show that Cdc42-interacting protein 4 is a Src substrate that localizes to invadopodia in MDA-MB-231 breast tumor cells expressing activated Src. [J Cell Sci]

Novel CCL21-Vault Nanocapsule Intratumoral Delivery Inhibits Lung Cancer Growth
Researchers are assessing the efficacy of intratumoral injection of dendritic cells transduced with an adenoviral vector expressing the secondary lymphoid chemokine (CCL21) gene (Ad-CCL21-DC) in a phase I trial in advanced non-small cell lung cancer. [PLoS One]

Immune and Genetic Correlates of Vaccine Protection Against Mucosal Infection by SIV in Monkeys
Investigators used a nonhuman primate model to define immune and genetic mechanisms of protection against mucosal infection by the simian immunodeficiency virus (SIV). [Sci Transl Med]

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POLICY

Holdren’s Response to Ban on China Science Partnerships Draws GOP Ire
The Obama Administration has carved out a loophole in the recent congressional ban on scientific interactions with China that would permit most activities between the two countries to continue. But that interpretation doesn’t sit well with Republicans in the House of Representatives who drafted the language, one of whom said that ignoring the ban could imperil funding for NASA or other science agencies. [House of Representatives, United States]

Despite Canadian Government Woes, Neuroscience Should Win Out
When Canada’s Conservative government presented its 2011 budget in late March, the fiscal plan didn’t contain too many surprises for science funding. Like previous budgets, the proposal offered modest increases to the country’s national research agencies and replenished the coffers of Genome Canada, its genomics and proteomics outfit. But the budget also contained a flashy and unprecedented new move: a multimillion-dollar earmark for neuroscience research. [Canadian Conservative Government, Canada]

French Researchers Balk at Limits on African Travel
French scientists are up in arms about the freeze their universities and research organizations have placed on field work in Mauritania, Mali, and Niger in response to the deteriorating security situation in those countries. [National Centre for Scientific Research, France]

Open Letters Fly as ESF Nears Key Vote on Future
A flurry of open letters have been flitting across Europe in the run-up to a special general assembly of the European Science Foundation (ESF), which is about to make a key decision on its future as a research funding agency. [European Science Foundation, France]

European Science Foundation Members Fumble Merger Plans
The long-planned creation of a new body to speak for European science was thrown into disarray at a special general assembly of the European Science Foundation (ESF) when its member organizations backed away from proposals to merge with EuroHORCs, an informal body that now represents Europe’s national funding agencies. [European Science Foundation, France]

Entries Flood Naming Contest for European Science Funding Program
The European Commission’s contest to find a more inspiring name for its key science and technology funding program has already received a respectable 1000 entries. [European Commission, Belgium]

Russia Pledges $4 Billion for Pharma-2020 Plan
Speaking at the opening of a new birth center in Ryazan on 11 March, Prime Minister Vladimir Putin stated that the government wants to boost Russia’s presence on the world biopharma stage to 3–5% in the next decade. [Government of the Russian Federation, Russia]

Bristol-Myers, Novartis Cancer Drugs Are Under U.K. Cost Review
Bristol-Myers Squibb Co.’s Sprycel and Novartis AG’s Tasigna are under review by the U.K. health-cost regulator for the treatment of a rare blood cancer because the benefits of the drugs may not justify their high prices. [National Institute for Health and Clinical Excellence, United Kingdom]


BUSINESS

Teva to Acquire Cephalon in $6.8 Billion Transaction
Teva Pharmaceutical Industries Ltd. and Cephalon, Inc. announced that their Boards of Directors have unanimously approved a definitive agreement under which Teva will acquire all of the outstanding shares of Cephalon for $81.50 per share in cash, or a total enterprise value of approximately $6.8 billion. [Teva Pharmaceutical Industries Ltd. Press Release]

InVivo Therapeutics and The Miami Project to Cure Paralysis Form Strategic Research Collaboration to Develop Novel Treatments for Spinal Cord Injuries
InVivo Therapeutics and The University of Miami Miller School of Medicine’s Miami Project to Cure Paralysis announced a strategic research collaboration for the development of novel spinal cord injuries treatments. [InVivo Therapeutics Press Release]

Molecular Templates Announces RNAi Drug-Delivery Research Collaboration with Alnylam Pharmaceuticals
Molecular Templates, Inc. announced that it has entered into a research collaboration with Alnylam Pharmaceuticals, Inc. to evaluate and develop Molecular Templates’ proprietary technology for targeted delivery of RNAi therapies. [Molecular Templates, Inc. Press Release]

Oxford BioMedica Broadens 5T4 Antibody Collaboration with Pfizer
Oxford BioMedica plc announced that it has signed an amendment to broaden its licensing agreement with Pfizer Inc. regarding the development of therapeutic products which target the Company’s proprietary 5T4 tumor antigen for the treatment of cancer. [Oxford Biomedica plc Press Release]

Debiopharm and Yale Announce an Exclusive License Agreement for the Development and Commercialization of Debio 1036, a First-In-Class Inhibitor for Autoimmune and Inflammatory Diseases
Debiopharm Group™ and Yale University announce an exclusive worldwide license agreement concerning the development and commercialization of Debio 1036, a first-in-class inhibitor for autoimmune and inflammatory diseases. [Debiopharm Group™ Press Release]

Prometheus Obtains Exclusive US Commercialization Rights for RENCAREX®
Prometheus Laboratories Inc. announced that it has signed an exclusive agreement with WILEX AG for commercialization rights in the United States for RENCAREX® (girentuximab). [Prometheus Laboratories Inc. Press Release]

ProFibrix Secures Funding for Progression of Lead Product into Late Stage Clinical Development and Announces Management and Supervisory Board Appointment
ProFibrix B.V. announced the successful closing of a series B follow-on financing. In conjunction with the financing and to support the company’s next stage of development towards commercialization, ProFibrix also announced several management and Supervisory Board appointments. [ProFibrix B.V. Press Release]

MDxHealth Receives USD 1.1 Million European Grant to Progress Bladder Cancer Program
MDxHealth SA announced that together with partner NovioGendix B.V. has received a USD 1.1 million grant from Eurotrans-Bio to progress its bladder cancer program. [MDxHealth SA Press Release]

Nearly 30 Percent of New CIRM Awards Go to UC San Diego Stem Cell Researchers
University of California (UC), San Diego scientist garnered 8 of the total 27 of Basic Biology III awards announced by the Independent Citizens’ Oversight Committee of the California Institute for Regenerative Medicine (CIRM). [University of California, San Diego Press Release]

UCSF Stem Cell Studies to Focus on Muscular Dystrophy, Heart Disease, Cancer
Three University of California, San Francisco (UCSF) scientists have received grants from the California Institute for Regenerative Medicine to advance their investigations of treatment strategies for degenerative muscle diseases, such as muscular dystrophy, and heart disease, and to determine why human embryonic stem cells are susceptible to forming tumors. [University of California, San Francisco Press Release]

Six UCLA Stem Cell Scientists Awarded More than $8 Million in State Grants
Six scientists with the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at the University of California, Los Angeles (UCLA) were awarded more than $8 million in grants from California’s state stem cell agency on May 3 to investigate basic mechanisms underlying stem cell biology and differentiation. [University of California, Los Angeles Press Release]

Silence Therapeutics Issued Japanese Patent Covering Its Core RNA Interference (RNAi) Technology
Silence Therapeutics plc announces the issuance of patent 4,705,370, titled “Further Novel Forms of Interfering RNA Molecules,” by the Japanese Patent Office. [Silence Therapeutics plc Press Release]

Cytori Appoints Tommy G. Thompson to Its Board; Names Lloyd Dean Chairman
Cytori Therapeutics elected the Honorable Tommy G. Thompson as an independent member of Cytori’s Board of Directors. In addition, the Company’s Board of Directors has elected Mr. Lloyd H. Dean to serve as Chairman of the Board. [Cytori Therapeutics Press Release]

National Academy of Sciences Members and Foreign Associates Elected
The National Academy of Sciences announced the election of 72 new members and 18 foreign associates from 15 countries in recognition of their distinguished and continuing achievements in original research. [National Academy of Sciences Press Release]

Professor Ingham Honored at National Awards
Professor Eileen Ingham has been recognized for her achievements in scientific research at a prestigious awards ceremony held at the Royal Academy of Engineering in London. [University of Leeds Press Release]


NIH

Martha J. Somerman, D.D.S., Ph.D., Named Director of the National Institute of Dental and Craniofacial Research
Martha J. Somerman, D.D.S., Ph.D., has been appointed as director of the National Institute of Dental and Craniofacial Research.

Funding Opportunity Center for Inherited Disease Research (CIDR) High Throughput Genotyping and Sequencing Resource Access (X01) (PAR-11-210)

Office of the Director, National Institutes of Health; Notice of Closed Meeting (FR Doc. 2011-10667)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-10670)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-10675)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-10731)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-10733)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-10749)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-11033)

Center for Scientific Review; Notice of Closed Meeting (FR Doc No: 2011-11176)

Center for Scientific Review; Notice of Closed Meeting (FR Doc No: 2011-11177)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-11204)

Center for Scientific Review; Amended Notice of Meeting (FR Doc. 2011-10742)

Center for Scientific Review; Amended Notice of Meeting (FR Doc. 2011-11031)

Government-Owned Inventions; Availability for Licensing (FR Doc No: 2011-11055)

National Cancer Institute; Notice of Closed Meeting (FR Doc No: 2011-11179)

National Cancer Institute; Notice of Closed Meeting (FR Doc No: 2011-11180)


CBER

SOPP 8422: Processing of Trans-BLA Submissions

April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes

May 4, 2011 Approval Letter – Recombivax HB


REGULATORY

FOOD AND DRUG ADMINISTRATION (United States)

Advisory Committee; Medical Imaging Drugs Advisory Committee; Reestablishment [FR Doc. 2011-10813]

Determination of Regulatory Review Period for Purposes of Patent Extension; VOTRIENT [Docket No. FDA-2010-E-0296]

Science Board Advisory Committee; Notice of Meeting [Docket No. FDA-2011-N-0002]

Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) [FR Doc No: 2011-11073]


EUROPEAN MEDICINES AGENCY (European Union)

Monitoring of Products Originating from Japan for the Possibility of Radioactivity
The European Medicines Agency is working with its European and international regulatory partners to monitor and evaluate the possible risk of radioactive contamination of medicines manufactured in Japan following the radiation leak from the Fukushima Daiichi nuclear power plant.

Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 3-5 May 2011


MEDICINES AND HEALTHCARE REGULATORY AGENCY (United Kingdom)

Information Sent to Healthcare Professionals in April About the Safety of Medicines
Monthly lists of letters for healthcare professionals on the safety of medicines.

Earlier Access to Medicines Scheme Update


THERAPEUTIC GOODS ADMINISTRATION (Australia)

Therapeutic Goods Administration – New Website
On 4 May 2011, the Therapeutic Goods Administration (TGA) launched its new corporate website at
http://www.tga.gov.au. The new website has been designed to improve the experience of visitors to the website, and to promote openness and transparency of TGA activities.

The TGA’s Risk Management Approach


EVENTS

NEW Science AAAS Webinar: Identifying Novel Cancer Therapeutic Targets: Real-time, Label-free Cell Monitoring in RNAi Profiling
May 18, 2011
Webinar
 
NEW The Power of Modeling Human Disease in NSG Mice
May 19, 2011
Webinar

NEW International Symposium on Clinical and Basic Investigation in Glioblastoma
June 23-25, 2011
Valencia, Spain

NEW
 Joint TuMIC – MRS – CF: New Concepts in Cancer Metastasis
June 25-28, 2011
Lisbon, Portugal

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.


JOB OPPORTUNITIES

Lab Technologist – Human Embryonic and Induced Pluripotent Stem Cells (STEMCELL Technologies)

Postdoctoral Research Fellows (Stem Cells) (A*Star Bioprocessing Technology Institute) 

Quality Assurance Manager – Program in Children’s Regenerative Medicine (The University of Texas Medical School at Houston)

Implementation Coordinator – Maternity Leave Contract (STEMSOFT Software Inc.) 

Tenure Track, Assistant/Associate Professor (University of Missouri-Kansas City School of Medicine)

Postdoc – Laboratory of Molecular Tumor Genetics (Duke-NUS Graduate Medical School)

Postdoctoral Research Position – Mucosal Immunology (Department of Microbiology and Immunology, Columbia University)

Postdoctoral Position – Vascular Smooth Muscle Biology (Boston University Medical School)

Supervisor Cell Therapy Laboratory – Cord Blood Bank (The University of Texas MD Anderson Cancer Center)

Supervisor Cell Therapy Lab (The University of Texas MD Anderson Cancer Center) 

Postdoctoral Positions in Immune Cell Activation (Institut de Recherches Cliniques de Montréal)

Postdoctoral Position in Developmental Neurobiology (Institut de Recherches Cliniques de Montréal)


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