Volume 12.03 | Jan 24

Cell Therapy News 12.03, January 24, 2011.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  

TOP STORY  


MicroRNA Suppresses Prostate Cancer Stem Cells and Metastasis 
A small slice of RNA inhibits prostate cancer metastasis by suppressing a surface protein commonly found on prostate cancer stem cells. [Press release from The University of Texas MD Anderson Cancer Center discussing online prepublication in Nature Medicine]

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SPECIAL FEATURES


A Very Sad Loss – Stem Cell Pioneer Ernest A. McCulloch Passes Away
It is with great sadness that scientists honor the life and extraordinary contributions of Dr. Ernest “Bun” McCulloch who passed away on Wednesday, January 19th, 2011. Dr. McCulloch, along with his close friend and colleague, Dr. James Till, was a pioneer in the field of stem cell research. [Canadian Stem Cell Foundation Press Release]

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SCIENCE NEWS


Team Views Genome as It Turns On and Off Inside Cells
Researchers have developed a new approach to decoding the vast information embedded in an organism’s genome, while shedding light on exactly how cells interpret their genetic material to create RNA messages and launch new processes in the cell. [Press release from the University of California, San Francisco discussing online prepublication in Nature]

Cancer Scientists Discover Genetic Diversity in Leukemic Propagating Cells
Cancer scientists have found that defective genes and the individual leukemia cells that carry them are organized in a more complex way than previously thought. [Press release from the University Health Network discussing online prepublication in Nature]

Research Shows When Stem Cell Descendants Lose Their Versatility
New research defines the point at which hair follicle stem cells abandon their trademark versatility, or “stemness,” having left their niche to make new hairs. It also shows how these fated stem cell descendants then regulate the activity of their forebears. [Press release from Rockefeller University discussing online prepublication in Cell]

Landmark Study Demonstrates That ‘Complexes Matter’ in How Epigenetic Inhibitors Interact with Their Drug Target
Results of the first ever chemoproteomic study of inhibition of HDAC (Histone Deacetylase) complexes open up the potential for a new way of studying potency and selectivity for inhibitors of epigenetic drug targets, such as HDACs. In the study, scientists demonstrated for the first time that complexes really matter to how small molecule inhibitors ‘see’ their target. [Press release from Cellzome discussing online prepublication in Nature Biotechnology]

Molecular Battle in Cancer Cells Offers Clues for Treatment
Researchers investigating a genetic mutation in brain cancer and leukemia patients have discovered how one cancer metabolite battles another normal metabolite to contribute cancer development. Helping the “good guys” win that battle could yield new approaches for treatment. [Press release from the University of North Carolina at Chapel Hill School of Medicine discussing online prepublication in Cancer Cell]

Mother’s Stem Cells Likely Key to Treating Genetic Disease Before Birth
Through a series of mouse model experiments, a research team determined that a mother’s immune response prevents a fetus from accepting transplanted blood stem cells, and yet this response can be overcome simply by transplanting cells harvested from the mother herself. [Press release from the University of California, San Francisco discussing online prepublication in the Journal of Clinical Investigation]

Investigational Compound Offers Novel Anti-IGF Approach to Inhibit Growth of Cancer Cells
MedImmune’s Oncology group announced preclinical results showing that MEDI-573, a targeted monoclonal antibody, broadly suppresses pathways that have been shown to play a critical role in the development and progression of many solid tumors. [Press release from MedImmune, LLC discussing online prepublication in Cancer Research]

Researchers Find Indirect Path to Attack Breast Cancer Stem Cells
Scientists have identified a potential new way of attacking breast cancer stem cells. They found that breast cancer stem cells are regulated by mesenchymal stem cells. [Press release from the University of Michigan Comprehensive Cancer Center discussing online prepublication in Cancer Research]

Researchers from Case Western Reserve and Athersys Publish Landmark Study Showing Regenerative Benefit of MultiStem Therapy After Spinal Cord Injury
Researchers observed that administration of Multipotent Adult Progenitor Cells following spinal cord injury in rodent models prevented the retraction of neurons, a process referred to as “axonal dieback,” reduced inflammation in the region of injury, and also promoted the regrowth of neurons. [Press release from Athersys, Inc. discussing online prepublication in the Journal of Neuroscience]

Blocking Rogue Gene Could Stop the Spread of Most Cancers
Scientists have discovered a rogue gene which — if blocked by the right drugs — could stop cancer in its tracks. It is hoped the research will lead to new drugs that halt the critical late stage of the disease when cancer cells spread to other parts of the body. [Press release from the University of East Anglia discussing online prepublication in Oncogene]

Go Figure: Math Model May Help Researchers with Stem Cell, Cancer Therapies
The difficult task of sorting and counting prized stem cells and their cancer-causing cousins has long frustrated scientists looking for new ways to help people who have progressive diseases. But in a development likely to delight math teachers, researchers have devised a series of mathematical steps that accomplishes what the most powerful microscopes, high-throughput screening systems and protein assays have failed to do — assess how rapidly stem cells and their malignant, stemlike alter egos increase their numbers. [Press release from the University of Florida discussing online prepublication in PLoS One]

Team Creates 'Engineered Organ' Model for Breast Cancer Research
Researchers have reproduced portions of the female breast in a tiny slide-sized model dubbed “breast on-a-chip” that will be used to test nanomedical approaches for the detection and treatment of breast cancer. [Press release from Purdue University discussing online prepublication in Integrative Biology]

Putting Up a Struggle Against Cancer
Scientists have discovered that cells lining the blood vessels secrete molecules that suppress tumor growth and keep cancer cells from invading other tissues, a finding that could lead to a new way to treat cancer. Researchers say that implanting such cells adjacent to a patient’s tumor could shrink a tumor or prevent it from growing back or spreading further after surgery or chemotherapy. [Press release from Massachusetts Institute of Technology discussing online prepublication in Science Translational Medicine]

Researchers Develop New Method of Targeting AIDS Virus
Scientists have developed a new method of targeting the AIDS virus that may provide a powerful one-two punch against HIV infection. The research team developed a small piece of genetic material — called an RNA aptamer — that both interferes with HIV’s ability to infect cells and acts as a delivery vehicle for another anti-HIV molecule. [Press release from City of Hope discussing online prepublication in Science Translational Medicine]

Pervasis to Present Interim Data from Phase I/II Clinical Study of Novel Cell Therapy Targeting Peripheral Artery Disease at International Conference on Cell Therapy for Cardiovascular Diseases
Pervasis Therapeutics, Inc. presented interim data from the company’s Phase I/II clinical study of PVS-10200, an investigational cell-based therapy under development to prevent restenosis in patients with peripheral arterial disease who undergo an angioplasty and stent procedure in the superficial femoral artery. [Press release from Pervasis Therapeutics, Inc. discussing research presented at the 6th International Conference on Cell Therapy for Cardiovascular Disease]

Adipose-Derived Regenerative Cell (ADRC) Therapy Associated with Reduction in Arrhythmia in Acute Heart Attack Patients
Cytori Therapeutics announced the presentation of data demonstrating a statistically significant reduction in ventricular tachyarrhythmias following adipose-derived regenerative cell therapy in patients with acute heart attack. [Press release from Cytori Therapeutics, Inc. discussing research presented at the 6th International Conference on Cell Therapy for Cardiovascular Disease]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Nascent Transcript Sequencing Visualizes Transcription at Nucleotide Resolution
Researchers present an approach (native elongating transcript sequencing, NET-seq), based on deep sequencing of 3’ ends of nascent transcripts associated with RNA polymerase, to monitor transcription at nucleotide resolution. [Nature]

Evolution of Human BCR-ABL1 Lymphoblastic Leukemia-Initiating Cells
Using xenografting and DNA copy number alteration profiling of human BCR-ABL1 lymphoblastic leukemia, researchers demonstrate that genetic diversity occurs in functionally defined leukemia-initiating cells and that many diagnostic patient samples contain multiple genetically distinct leukemia-initiating cell subclones. [Nature]

Dynamics Between Stem Cells, Niche, and Progeny in the Hair Follicle
Researchers exploited the hair follicle to define the point at which stem cells become irreversibly committed along a differentiation lineage. [Cell]

Chemoproteomics Profiling of HDAC Inhibitors Reveals Selective Targeting of HDAC Complexes
A combination of affinity capture and quantitative mass spectrometry revealed the selectivity with which 16 histone deacetylase (HDAC) inhibitors target multiple HDAC complexes scaffolded by ELM-SANT domain subunits, including a novel mitotic deacetylase complex. [Nat Biotechnol]
 
The MicroRNA miR-34a Inhibits Prostate Cancer Stem Cells and Metastasis by Directly Repressing CD44
The study shows that miR-34a is a key negative regulator of CD44+ prostate cancer cells and establishes a strong rationale for developing miR-34a as a novel therapeutic agent against prostate cancer stem cells. [Nat Med]

Oncometabolite 2-Hydroxyglutarate Is a Competitive Inhibitor of Alpha-Ketoglutarate-Dependent Dioxygenases
Researchers demonstrate that 2-hydroxyglutarate is a competitive inhibitor of multiple alpha-ketoglutarate-dependent dioxygenases, including histone demethylases and the TET family of 5-methlycytosine (5mC) hydroxylases. [Cancer Cell]

Maternal T Cells Limit Engraftment After In Utero Hematopoietic Cell Transplantation in Mice
Researchers demonstrated that there is macrochimerism of maternal leukocytes in the blood of unmanipulated mouse fetuses, with substantial increases in T cell trafficking after in utero hematopoietic cell transplantation. [J Clin Invest]

Breast Cancer Stem Cells Are Regulated by Mesenchymal Stem Cells Through Cytokine Networks
Bone marrow-derived mesenchymal stem cells may accelerate human breast tumor growth by generating cytokine networks that regulate the cancer stem cell population. [Cancer Res]

Determination of Somatic and Cancer Stem Cell Self-Renewing Symmetric Division Rate Using Sphere Assays
The neurosphere assay mathematical model presented here allows the assessment of the rate malignant stem-like cells expand via symmetric division and the evaluation of the effects of therapeutics on the self-renewal and proliferative activity of this clinically relevant population that drive tumor growth and recurrence. [PLoS One]

Stromal Endothelial Cells Directly Influence Cancer Progression
Findings add to an emerging appreciation of endothelial cell (EC)-regulatory effects that transcend their structural roles and pave the way for improved characterization and control of EC-cancer cross-talk interactions for diagnosis, prognosis, and treatment of cancer. [Sci Transl Med]

An Aptamer-siRNA Chimera Suppresses HIV-1 Viral Loads and Protects from Helper CD4+ T Cell Decline in Humanized Mice
Researchers have developed a different combination approach for the treatment of HIV infection in which an RNA aptamer, with high binding affinity to the HIV-1 envelope protein and virus neutralization properties, is attached to and delivers a small interfering RNA (siRNA) that triggers sequence-specific degradation of HIV RNAs. [Sci Transl Med]

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POLICY


Four Freshmen Grab Leadership Posts on House Science Committee
Representative Ralph Hall (R-TX), the new chair of the House of Representatives Science, Space and Technology Committee, announced that freshmen will lead four of the five subcommittees on his panel. [House of Representatives Science, Space and Technology Committee, United States]

U.K. Scientists: Budget Threatens Facilities
Heads of the United Kingdom's research councils warned politicians that delaying capital investments due to funding cuts will harm the country's scientific standing. “It will in principle damage our international competitiveness,” said Keith Mason, chief executive of the Science and Technology Facilities Council. [House of Commons Science and Technology Select Committee, United Kingdom]

France Mulls Embryo Research Reform
France's tight restrictions on human embryonic stem cell research might soon be eased. As parliament prepares to debate the issue next month, researchers' calls for reform are garnering political support. [Ministry of Science, France]

Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting (FR Doc. 2011-1266) [Health Resources and Services Administration, United States]

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BUSINESS


International Society for Cellular Therapy (ISCT) Launches Inaugural Cell Therapy Commercial Development Focus Group on Peripheral Vascular Disease
In keeping with its commitment to connect industry, regulatory experts, therapeutic societies and translational centers to advance emerging cellular therapies, ISCT announced its first commercial development focus group addressing Cell Therapies for Peripheral Vascular Disease. [Reuters]

NeoStem Acquires Progenitor Cell Therapy
NeoStem, Inc. and Progenitor Cell Therapy LLC announced the closing of their previously announced merger transaction. [NeoStem, Inc. Press Release]

Sanofi-aventis Extends Tender Offer for All Outstanding Shares of Genzyme
Sanofi-aventis announced that it has extended its tender offer for all outstanding shares of common stock of Genzyme Corporation at $69.00 per share, net to the seller in cash, without interest and less any required withholding taxes. [Sanofi-aventis Press Release]

Theraclone and Pfizer Enter into Infectious Disease and Cancer Antibody Discovery Collaboration
Theraclone Sciences, Inc. announced that they have entered into a multi-year research and development collaboration with Pfizer. [Theraclone Sciences, Inc. Press Release]

Agenus Announces Research Collaboration with Memorial Sloan-Kettering Cancer Center
Agenus Inc. announced it has entered into a research agreement with Memorial Sloan-Kettering Cancer Center using Agenus’ proprietary cancer vaccine technology. [Agenus Inc. Press Release]

BC Clinical Research Infrastructure Network Launched to Attract Significant Investment in Clinical Research in British Columbia
Through a new innovative collaboration, British Columbia is positioning itself to attract a greater portion of the more than half billion dollars a year spent on clinical trials in Canada. In order to build a ‘friendlier climate’ and more streamlined process to attract an increased proportion of this investment, the BC Clinical Research Infrastructure Network has now been launched. [LifeSciences British Columbia Press Release]

Khalifa Foundation Grants MD Anderson $150 Million for Cancer Research
The Khalifa bin Zayed Al Nahyan Charity Foundation is granting $150 million to The University of Texas MD Anderson Cancer Center to support genetic-analysis based research, diagnosis and treatment of cancer. [The University of Texas MD Anderson Cancer Center Press Release]

Pluristem on Track to Proceed to a Phase II/III Clinical Trial in Critical Limb Ischemia (CLI) Under a Joint FDA-EMA Protocol, and a Phase II Clinical Trial in Intermittent Claudication (IC)
Pluristem Therapeutics, Inc. announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company’s planned clinical development program for PLX-PAD. [Pluristem Therapeutics, Inc. Press Release]

Pervasis Therapeutics to Develop Novel Cell-Based Approach to Target Tumor Environment, Prevent Cancer Recurrence
Pervasis Therapeutics, Inc. announced that the company is pursuing a matrix-embedded endothelial cell-based therapy (PVS-30200) to target and regulate cell stroma in order to prevent key processes that play a role in advancing solid tumor growth and metastasis. [Pervasis Therapeutics, Inc. Press Release]

Lorus Therapeutics Enrolls First Patient in Phase I Clinical Study of Anticancer Drug LOR-253 
Lorus Therapeutics Inc. announced the enrollment of the first cancer patient in a Phase I clinical study evaluating its small molecule anticancer drug candidate LOR-253. [Lorus Therapeutics Inc. Press Release]

Aastrom Receives Key U.S. Composition of Matter Patent for Autologous Cell Therapy
Aastrom Biosciences, Inc. announced that it has been granted a U.S. patent which provides composition of matter protection for its investigational expanded autologous cell therapy product. [Aastrom Biosciences, Inc. Press Release]

Soligenix Receives FDA Orphan Drug Designation for RiVax™ for the Prevention of Ricin Intoxication
Soligenix, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication. [Soligenix, Inc. Press Release]

Cytori Approved to Initiate Pivotal Stem & Regenerative Cell Heart Attack Trial in Europe; First ADVANCE Trial Site to Begin Enrollment in the Netherlands
Cytori received approval from The Netherlands to initiate a pivotal European trial, named ADVANCE, to investigate adipose-derived stem and regenerative cells, processed by the Celution® One System, in the treatment of patients with acute heart attacks. [Cytori Therapeutics, Inc. Press Release]

CIRM Appoints National Expert on Drug Development and Regulation as Vice President, Research and Development
The California Institute for Regenerative Medicine (CIRM) has named Ellen Feigal, M.D., as its first Vice President for Research and Development effective January 31. [California Institute for Regenerative Medicine Press Release]

Wisconsin Stem Cell Pioneer Wins Faisal International Prize
James Thomson, director of regenerative biology at the Morgridge Institute for Research and a University of Wisconsin-Madison researcher since 1994, learned that he is this year's co-winner of the prestigious King Faisal International Prize in Medicine. [Morgridge Institute for Research Press Release]


NIH
 

Federal Research Center Will Help Develop Medicines
The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines.

NIH's Plan to Break Up a Center
Anxiety continues to roil the biomedical community about a decision last month by the National Institutes of Health (NIH) to create a new center for translational research and, in the process, dismantle an existing center. NIH deputy director Lawrence Tabak posted online a “straw model” for how the pieces of the National Center for Research Resources might be distributed.

Office of Biotechnology Activities, Office of Science Policy, Office of the Director; Notice of Meeting (FR Doc. 2011-1244)
 
Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) (FR Doc. 2011-1037)
 
National Human Genome Research Institute; Notice of Closed Meeting (FR Doc. 2011-1247)

National Human Genome Research Institute; Notice of Closed Meetings (FR Doc. 2011-1148)

National Human Genome Research Institute; Notice of Closed Meeting (FR Doc. 2011-1141)

National Heart, Lung, and Blood Institute; Notice of Closed Meetings (FR Doc. 2011-1146)

National Cancer Institute; Notice of Closed Meetings (FR Doc. 2011-1150)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-1252)

National Center for Research Resources; Notice of Closed Meetings (FR Doc. 2011-1327)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-1128)

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CBER


November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Presentations 

January 13, 2011 Approval Letter – BCG Vaccine 

January 13, 2011 Approval Letter – Rotarix 

January 13, 2011 Approval Letter – Adacel  

January 13, 2011 Approval Letter – DECAVAC  

January 13, 2011 Approval Letter – Cervarix


REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

FDA to Improve Most Common Review Path for Medical Devices
The U.S. Food and Drug Administration unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting [Docket No. FDA-2010-N-0001]

Guidance for Industry: Process Validation: General Principles and Practices

EUROPEAN MEDICINES AGENCY (European Union)

Benefit-Risk Review of Multaq Started
Further to the report of two cases of serious liver injury in patients taking the anti-arrhythmic medicine Multaq (dronedarone), the European Commission has requested that the Agency’s Committee for Medicinal Products for Human Use assess all available data concerning the possible risks of liver injury associated with the use of Multaq and their impact on its benefit-risk balance.

Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 January 2011

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Media Release: Panel to Review the Transparency of the Therapeutic Goods Administration
An independent Review Panel has been commissioned by the Australian Government to provide recommendations on improving public access and understanding about the work of Australia's medicines regulator, the Therapeutic Goods Administration.



EVENTS 

NEW Advances in Stem Cell Research: Development, Regeneration and Disease
April 6-8, 2011
Paris, France

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

JOB OPPORTUNITIES

Lab Technologist – Cell Separation (STEMCELL Technologies)

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

Lab Technologist – Tissue Culture (STEMCELL Technologies)

Assistant Professor (University of Pittsburgh School of Medicine, Center for Cellular and Molecular Engineering)

Cell Therapy Manufacturing Manager (Opexa Therapeutics)

Post-Doctoral Positions (University of Texas MD Anderson Cancer Center)

Faculty Position Openings (Shanghai Advanced Research Institute, Chinese Academy of Sciences)
 
PhD Students – Stem Cell Differentiation and Cellular Reprogramming (Ulm University Hospital)

Senior Scientist – Embryonic Stem Cells – Hepatocytes (Hays Pharma)

Research Technician Position in Human Stem Cells (University of Pittsburgh)

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