Volume 11.49 | Dec 20

Cell Therapy News 11.49, December 20, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  

TOP STORY  


Nanoscale Gene “Ignition Switch” May Help Spot and Treat Cancer 
In a proof of principal study in mice, scientists have shown that a set of genetic instructions encased in a nanoparticle can be used as an “ignition switch” to rev up gene activity that aids cancer detection and treatment. [Press release from Johns Hopkins Medical Institutions discussing online prepublication in Nature Medicine]

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SCIENCE NEWS


Degradable Scaffolds for Tissues
Three-dimensional frameworks where cells can settle and grow tissues and organs are desired in regenerative medicine. Material scientists have now developed new scaffolds with special characteristics. [Press release from the University Würzburg discussing online prepublication in Nature Materials]

Researchers Create Early Disease Detection and Drug Delivery Device for Single Living Cells
A team of engineers, scientists and biologists have developed a carbon nanotube-based device for probing single living cells without damaging them. This technique will allow experts to identify diseases in their early stage and advance drug discovery. [Press release from Drexel University discussing online prepublication in Nature Nanotechnology]

Leukemia Stem Cell Discovery
Researchers have discovered that leukemic stem cells can be reversed to a pre-leukemic stage by suppressing a protein called beta-catenin found in the blood. [Press release from King’s College London discussing online prepublication in Cancer Cell]

Killing Drug-Resistant Melanoma Requires Combination Therapy
Patients whose melanoma lesions contain a mutation in the BRAF gene were successfully treated with a BRAF-specific inhibitor, PLX4032. Yet seven months after therapy began the tumors returned and resumed growing. Now, scientists explain why: the tumor learns to signal around the blocked gene by adjusting its molecular wiring. [Press release from The Wistar Institute discussing online prepublication in Cancer Cell]

Missing Molecules Hold Promise of Therapy for Pancreatic Cancer
The production of a particular cluster of genetic snippets known as microRNAs is dramatically reduced in human pancreatic tumor cells compared to healthy tissue. When researchers restored this tiny regulator, called miR-143/145, back to normal levels in human pancreatic cancer cells, those cells lost their ability to form tumors. [Press release from Johns Hopkins Medicine discussing online prepublication in Genes and Development]

Ovarian Cancer Advances When Genes Are Silenced
Researchers have found evidence of epigenetics at work on a genome-wide scale in cases of ovarian cancer. One major biological signaling pathway in particular was found to contain many genes influenced by DNA methylation — a mechanism for turning off genes — in tumor cells. [Press release from the Duke Cancer Institute discussing online prepublication in Genome Research]

“Magnetic Sponge” Could Be New Form of Drug and Cell Delivery
Engineers have developed a “magnetic sponge” that after implantation into a patient can “squeeze” out drugs, cells, or other agents when passed over by a magnet. [Press release from the Harvard School of Engineering and Applied Sciences discussing online prepublication in the Proceedings of the National Academy of Sciences USA]
 
Immunotherapy May Inhibit Tumor Growth
A combination therapy of immune stimulants and regulatory molecules appears to block angiogenesis critical to tumor development. [Press release from Modern Medicine discussing online prepublication in Cancer Research]

Novel Therapy for Metastatic Kidney Cancer Developed
Researchers have developed a novel virus-based gene therapy for renal cell carcinoma that has been shown to kill cancer cells not only at the primary tumor site but also in distant tumors not directly infected by the virus. [Press release from Virginia Commonwealth University discussing online prepublication in Cancer Biology and Therapy]

Scientists Find Gene Clue in Smokers' Lung Cancer
Scientists have found a genetic alteration that occurs in a common type of lung cancer in smokers, which they say provides a target for developing much-needed new drugs against the often deadly tumors. [Press release from Reuters discussing online prepublication in Science Translational Medicine]

Excellent Safety and Reproducible Immunogenocity Demonstrated in Early Results of Phase IIa Trial for HIV Preventative Vaccine
GeoVax Labs, Inc. announced that early results from part A of an ongoing Phase IIa clinical trial indicate an excellent safety profile and highly reproducible immunogenicity. [GeoVax Labs, Inc. Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Degradable Polyester Scaffolds with Controlled Surface Chemistry Combining Minimal Protein Adsorption with Specific Bioactivation
Researchers present a one-step preparation of fully synthetic, bioactive and degradable extracellular matrix-mimetic scaffolds by electrospinning, using poly(D,L-lactide-co-glycolide) as the matrix polymer. [Nat Mater]

Tumor-Specific Imaging Through Progression Elevated Gene-3 Promoter-Driven Gene Expression
Researchers show that the progression elevated gene-3 promoter, derived from a rodent gene mediating tumor progression and metastatic phenotypes, can be used to drive imaging reporters selectively to enable detection of micrometastatic disease in mouse models of human melanoma and breast cancer using bioluminescence and radionuclide-based molecular imaging techniques. [Nat Med]

Multifunctional Carbon-Nanotube Cellular Endoscopes
Researchers report a carbon-nanotube-based endoscope for interrogating cells, transporting fluids and performing optical and electrochemical diagnostics at the single organelle level. [Nat Nanotechnol]

Beta-Catenin Mediates the Establishment and Drug Resistance of MLL Leukemic Stem Cells
Results unveil previously unrecognized multifaceted functions of beta-catenin in the establishment and drug-resistant properties of MLL stem cells, highlighting it as a potential therapeutic target for an important subset of acute myeloid leukemias. [Cancer Cell]

Acquired Resistance to BRAF Inhibitors Mediated by a RAF Kinase Switch in Melanoma Can Be Overcome by Cotargeting MEK and IGF-1R/PI3K
Researchers describe a model of resistance to BRAF inhibitors developed by chronic treatment of BRAFV600E melanoma cells with the BRAF inhibitor SB-590885; these cells are cross-resistant to other BRAF-selective inhibitors. [Cancer Cell]

Genomic Safe Harbors Permit High Beta-Globin Transgene Expression in Thalassemia Induced Pluripotent Stem Cells
Researchers describe a strategy to genetically modify human induced pluripotent stem cells at ‘safe harbor’ sites in the genome, which fulfill five criteria based on their position relative to contiguous coding genes, microRNAs and ultraconserved regions. [Nat Biotechnol]

Repression of the miR-143/145 Cluster by Oncogenic Ras Initiates a Tumor-Promoting Feed-Forward Pathway
Loss of miR-143/145 expression is observed frequently in KRAS mutant pancreatic cancers, and restoration of these microRNAs abrogates tumorigenesis. [Genes Dev]

Epigenetic Suppression of the TGF-Beta Pathway Revealed by Transcriptome Profiling in Ovarian Cancer
Data suggest that accumulation of age-related epigenetic modifications leads to suppression of TGF-beta signaling and contributes to ovarian carcinogenesis. [Genome Res]

Active Scaffolds for On-Demand Drug and Cell Delivery
Researchers present a new active porous scaffold that can be remotely controlled by a magnetic field to deliver various biological agents on demand. [Proc Natl Acad Sci U S A]

Active Immunotherapy Induces Antibody Responses That Target Tumor Angiogenesis
The results delineate an immunotherapy-induced host response that broadly targets the angiogenic network in the tumor microenvironment. [Cancer Res]

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POLICY


Presidential Commission on Bioethics Calls for Enhanced Federal Oversight in Emerging Field of Synthetic Biology
The Presidential Commission for the Study of Bioethical Issues released its first report — a wide-ranging review of the emerging field of synthetic biology — issuing 18 recommendations including a call for coordinated federal oversight of scientists working in both large institutions and smaller settings. [The Presidential Commission for the Study of Bioethical Issues, United States]

Senate Spending Bill Would Boost National Science Foundation, NIH Budgets
In some good fiscal news for the U.S. science community, a Senate spending panel has crafted a 2011 federal budget that would give several science agencies increases that are close to their requested levels. [Senate, United States]
 
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BUSINESS


bluebird bio and Généthon Announce Manufacturing Research Collaboration Centered on Lentiviral Vectors for Gene Therapy
bluebird bio (formerly Genetix Pharmaceuticals Inc.) and Généthon announced a research collaboration focused on process development and scale up efforts for the manufacturing of lentiviral vectors. [bluebird bio Press Release]
 
Sanofi-aventis and Merck KGaA Sign Agreement to Jointly Investigate Novel Combinations Against Cancer
Sanofi-aventis announced that sanofi-aventis U.S. Inc. has signed a worldwide research and development agreement with Merck KGaA, Darmstadt, Germany, under which Merck’s division Merck Serono and sanofi-aventis U.S. Inc. will collaboratively investigate novel experimental combinations of agents that could block specific pathways in cancer cells. [Sanofi-aventis Press Release]
 
Metabolic Disease Alliance with MedImmune
Evotec AG announced that via its subsidiary Develogen AG it has entered into a license and collaboration agreement with MedImmune (the global biologics unit of AstraZeneca), in the diabetes therapeutic area, with a particular focus on the regeneration of insulin producing beta cells. [Evotec AG Press Release]
 
Anaphore Enters R&D Partnership with Mitsubishi Tanabe Pharma to Develop and Commercialize Novel Protein Pharmaceuticals for Autoimmune Disorders
Anaphore Inc. announced that the company has entered into a partnership with Mitsubishi Tanabe Pharma Corporation (Osaka, Japan) for the research, development and commercialization of novel protein therapies for autoimmune disease. [Anaphore Inc. Press Release]
 
Horizon Secures License from Case Western to 35 Endogenously Tagged Human Isogenic Cell Lines
Horizon Discovery announced it has secured worldwide exclusive rights to a panel of new human isogenic cell models developed by Dr. Zhenghe Wang, Assistant Professor of Genetics at Case Western Reserve University School of Medicine, using its proprietary rAAV GENESIS gene-editing platform. [Horizon Discovery Limited Press Release]
 
Lpath Grants Pfizer Exclusive Option for Worldwide License for iSONEP
Lpath, Inc. has entered into an agreement providing Pfizer with an exclusive option for a worldwide license to develop and commercialize iSONEP™, Lpath's lead monoclonal antibody product candidate, which is being evaluated for the treatment of wet age-related macular degeneration and other ophthalmology disorders. [Lpath, Inc. Press Release]

Gilead Sciences to Acquire Arresto Biosciences for $225 Million
Gilead Sciences, Inc. and Arresto Biosciences, Inc., a privately-held, development-stage biotechnology company focused on medicines to treat fibrotic diseases and cancer, announced the signing of a definitive agreement pursuant to which Gilead will acquire Arresto. [Gilead Sciences, Inc. Press Release]
 
NovImmune Raises Additional CHF 20 Million
NovImmune announced, following its July 2010 deal with Genentech/Roche, that it obtained further financing of CHF 20 million. [NovImmune SA Press Release]

Cancer Research Institute Announces Launch of Cancer Vaccine Acceleration Fund
Cancer Research Institute, Inc. announced the launch of the Cancer Vaccine Acceleration Fund, a new model of philanthropic investment and academic-industry collaboration established in partnership with the Ludwig Institute for Cancer Research Ltd. to speed the clinical development of therapeutic cancer vaccines and other immune system-based therapies. [Cancer Research Institute, Inc. Press Release]

Tolerx Initiates Phase I Clinical Trial of TRX518, a First-in-Class Anti-GITR Antibody for the Treatment of Cancer
Tolerx, Inc. announced that it has initiated a Phase I clinical trial to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of TRX518, a monoclonal antibody designed to enhance the immune system by enabling T cells to more effectively attack cancer cells. [Tolerx, Inc. Press Release]

NOVAVAX Receives FDA Clearance to Launch Phase I RSV Vaccine Clinical Trial
Novavax, Inc. announced that the company’s Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food  and Drug Administration (FDA) and is no longer on clinical hold. [Novavax Inc. Press Release]
 
A Further Clinical Study Has Currently Been Started — A New Therapy Approach for the Treatment of Renal Cancer
The Charité – Medical University of Berlin has begun the implementation of the clinical study Phase I/II with the renal cancer medication MGN1601. With this product, an innovative cell-based gene therapy for the treatment of advanced renal cancer is entering the first important test phase. [MOLOGEN AG Press Release]
 
CEL-SCI Corporation Receives Government Approval from Ukraine to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer
CEL-SCI Corporation announced it has received governmental approval from the Health Authority, Ministry of Health of Ukraine, to begin enrollment of subjects for a Phase III clinical trial of Multikine® in Ukraine. [CEL-SCI Corporation Press Release]

Fibrocell Science, Inc. Submits Complete Response to FDA Regarding Azficel-T
Fibrocell Science, Inc. announced that it has submitted its complete response to the Complete Response letter issued by the U.S. Food & Drug Administration (FDA) regarding the Company’s Biologics License Application for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles. [Fibrocell Science, Inc. Press Release]

Massachusetts General Hospital's Warren Triennial Prize to Honor Pioneers of Cellular Reprogramming
The 2011 Warren Triennial Prize of Massachusetts General Hospital will be awarded to Shinya Yamanaka, MD, PhD, who discovered a method to convert adult cells into cells with characteristics of embryonic stem cells, and Rudolf Jaenisch, MD, whose extension of Yamanaka's work includes using those cells to generate animal models of important human diseases. [Massachusetts General Hospital Press Release]

CIRM Governing Board Re-Elects Robert Klein as Chair, Senator Art Torres and Duane Roth as Co-Vice Chairs
The Governing Board of the California Institute for Regenerative Medicine (CIRM), the state stem cell agency created by proposition 71, voted to re-elect current chair Robert Klein. [California Institute for Regenerative Medicine Press Release]

Plans Approved for Visionary Institute
Plans to build a world-leading medical research institute at St Pancras in London have been approved by councilors at Camden Town Hall. The UK Centre for Medical Research and Innovation, designed by the architects HOK with PLP Architecture, will have 1,500 staff including 1,250 scientists. [UK Centre for Medical Research and Innovation Press Release]

Horizon to Support 50 Centers of Excellence in Human Cellular Gene-Editing
Horizon Discovery has announced that it will commit resources to provide training and open access to its rAAV GENESIS human gene-editing platform for another 50 academic and not-for-profit research groups over the next five years, extending the GENESIS Gene Editing Consortium. [Horizon Discovery Limited Press Release]


NIH
 

NIH Accepts ACD Recommendations, Approves Four Additional Human Embryonic Stem Cell Lines
Francis S. Collins, M.D., Ph.D., Director, National Institutes of Health (NIH) accepted the recommendations of the Advisory Committee to the Director (ACD), NIH, and approved four additional lines for listing on the NIH Human Embryonic Stem Cell Registry. These four lines include two from Jawaharlal Nehru Centre for Advanced Scientific Research in Bangalore, India, and two from Cellartis in Goteborg, Sweden.
 
Collaboration Offers Clinical Center Resources to External Investigators
A new pilot partnership between the National Institutes of Health Clinical Center, the National Cancer Institute's Center for Cancer Research, and the Damon Runyon Cancer Research Foundation will offer some of the capabilities and expertise of America's research hospital to an external group of clinical investigators in cancer research.
 
National Library of Medicine; Notice of Meeting (FR Doc. 2010-31623)
 
National Library of Medicine; Notice of Meeting (FR Doc. 2010-31612)
 
National Cancer Institute; Amended Notice of Meeting (FR Doc. 2010-31739)

Submission for OMB Review; Comment Request; Transfusion-Transmitted Retrovirus and Hepatitis Virus Rates and Risk Factors: Improving the Safety of the U.S. Blood Supply Through Hemovigilance (FR Doc. 2010-31734)



CBER


Roster of the Blood Products Advisory Committee

Transcript for Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations 

Rho(D) Immune Globulin (Human) RhoGAM and MICRhoGAM Ultra-Filtered PLUS: Updated pH Specification Range

Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS Lot MVP105A1: Updated pH Specification Range


REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination

Defense Advanced Research Projects Agency and Food and Drug Administration Expanding In Vivo Biomarker Detection Devices Workshop [Docket No. FDA-2010-N-0001]

EUROPEAN MEDICINES AGENCY (European Union)

European Medicines Agency Facilitates Interaction Between Small and Medium-Sized Enterprises (SMEs)
The European Medicines Agency has launched a public SME registry providing information on companies which are registered as SMEs with the Agency.

Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2010


EVENTS (Listed by Date)

Functional Consequences of Structural Variation in the Genome
January 8-13, 2011
Steamboat Springs, United States

4th Annual OneMedForum
January 11-13, 2011
San Francisco, United States

COGEM Symposium: GM Viruses as Medicine: Panacea or Pandora's Box?
January 20, 2011
Amsterdam, The Netherlands

Extracellular Matrix and Cardiovascular Remodeling
January 23-28, 2011
Tahoe City, United States

5th Annual Stem Cells and Regenerative Medicine 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, D.C., United States

Phacilitate 9th Annual North American Vaccine Forum
January 24-26, 2011
Washington, D.C., United States

IQPC’s 4th Biobanking Conference
January 24-26, 2011
Philadelphia, United States

Keystone Symposia: Stem Cells in Development, Tissue Homeostasis and Disease
January 30-February 4, 2011
Santa Fe, United States

16th Proteomics Symposium
February 3-6, 2011
Lorne, Australia

36th Lorne Conference on Protein Structure and Function
February 6-10, 2011
Lorne, Australia

CMC Workshop: Translating Science into Successful Regulatory Submissions
February 7-9, 2011
Washington, D.C., United States

Stem Cell Research Forum of India 2nd Annual Meeting
February 8-11, 2011
Bangalore, India

23rd Lorne Cancer Conference
February 10-12, 2011
Lorne, Australia

32nd Lorne Genome Conference
February 13-15, 2011
Lorne, Australia

BMT Tandem Meetings (ASBMT/CIBMTR)
February 17-21, 2011
Honolulu, Hawaii

1st Annual Clinical Meeting of the Cell Society
February 18-19, 2011
La Jolla, United States

SMi Stem Cells 2011 – Innovation and Commercialisation
February 23-24, 2011
London, United Kingdom

Molecular Medicine Tri-Conference: Stem Cells – Revolutionizing Regenerative Medicine and Personalized Therapy 2011
February 23-25, 2011
San Francisco, United States

Molecular Medicine Tri-Conference: Inaugural Circulating Tumor Cells for Cancer Detection, Diagnosis, Prognosis and Treatment
February 23-25, 2011
San Francisco, United States

American Association for Cancer Research (AACR) Targeting PI3K/mTOR Signaling in Cancer
February 24-27, 2011
San Francisco, United States

Annual Meeting of the International Society for Cell & Gene Therapy of Cancer (ISCGT)
February 27-March 1, 2011
Doha, Qatar

9th Annual BioPartnering North America
February 27-March 1, 2011
Vancouver, Canada

18th Conference on Retroviruses and Opportunistic Infections (CROI 2011)
February 27-March 2, 2011
Boston, United States

Cell Culture World Congress 2011 – Optimising Cell Culture Development for Biopharmaceutical, Bioprocessing and Manufacture
February 28-March 2, 2011
Munich, Germany

6th Annual Stem Cell Summit
March 1, 2011
New York, United States

American Association for Cancer Research (AACR) Stem Cells, Development, and Cancer
March 3-6, 2011
Vancouver, Canada

Keystone Symposia: Stem Cells, Cancer and Metastasis
March 6-11, 2011
Dillon, United States

Cell Therapy Summit Europe (CTS Europe)
March 10-11, 2011
Maastricht, The Netherlands

PITTCON Conference & Expo 2011
March 13-18, 2011
Atlanta, United States

NEW DIA/FDA CDER/CBER Computational Science Annual Meeting 
March 14, 2011
Arlington, United States

BIO-Europe Spring 2011
March 14-16, 2011
Milan, Italy

The 6th International Conference on Oncolytic Viruses as Cancer Therapeutics
March 16-19, 2011
Las Vegas, United States

15th Annual Hilton Head Workshop – Regenerative Medicine, Innovations for Clinical Applications
March 16-19, 2011
Hilton Head Island, United States

HIV Evolution, Genomics and Pathogenesis
March 20-25, 2011
Whistler, Canada

StemCONN 11
March 22, 2011
Farmington, United States

United Kingdom National Stem Cell Network 2011 Annual Scientific Conference
March 30-April 1, 2011
York, United Kingdom

10th Annual New England Science Symposium
April 1, 2011
Boston, United States

American Association for Cancer Research (AACR) 102nd Annual Meeting 2011
April 2-6, 2011
Orlando, United States

Clinical Gene Transfer: State of the Art Conference and e-Chips European Congress on Human iPS Cells
April 7-9, 2011
Paris, France

5th RNAi & miRNA World Congress
April 26-27, 2011
Boston, United States

3rd Epigenetics World Congress
April 26-27, 2011
Boston, United States

Inaugural Next-Gen Sequencing Congress
April 26-27, 2011
Boston, United States

GTCbio 2nd International Conference on Cancer Immunotherapy & Immunomonitoring
May 2-5, 2011
Budapest, Hungary

Australasian Gene Therapy Society (AGTS) 7th Meeting
May 4-6, 2011
Melbourne, Australia

BioPartnering India
May 4-6, 2011
Bangalore, India

International Neural Transplantation and Repair 2011 (INTR11)
May 4-8, 2011
Clearwater Beach, United States

World Stem Cells & Regenerative Medicine Congress 2011
May 9-11, 2011
London, United Kingdom

2nd European Biomarkers Summit
May 18-19, 2011
London, United Kingdom

Inaugural Theranostics for Personalised Medicine
May 18-19, 2011
London, United Kingdom

International Society for Cellular Therapy (ISCT) 17th Annual Meeting
May 18-21, 2011
Rotterdam, The Netherlands

American Society of Gene and Cell Therapy (ASGCT) 14th Annual Meeting
May 18-22, 2011
Seattle, United States

13th Annual C21 BioVentures
May 24-26, 2011
Napa, United States

Gordon Research Conference: Viruses & Cells
May 29-June 3, 2011
Lucca (Barga), Italy

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – Europe 2010 Annual Conference
June 7-10, 2011
Granada, Spain

9th Annual International Cord Blood Transplantation Symposium
June 9-11, 2011
San Francisco, 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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