Volume 12.26 | Jul 4

Cell Therapy News 12.26, July 4, 2011
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
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Researchers Develop Safe and Effective Gene Therapy to Treat Severe Heart Failure
Researchers have found in a Phase II trial that a gene therapy stabilized or improved cardiac function in people with severe heart failure. [Press release from The Mount Sinai Medical Center discussing online prepublication in Circulation]



Investigators Develop Technique to Bypass iPSCs for Conversion of Human Fibroblasts to Dopaminergic Neurons
Researchers have developed a technique to convert mouse and human fibroblasts directly into dopaminergic neurons without having to first generate induced pluripotent stem cells (iPSCs). [Press release from Genetic Engineering & Biotechnology News discussing online prepublication in Nature]

Results Released for Two Drug Studies Designed to Slow Progression of Type 1 Diabetes
The results of two diabetes drug studies, including one that shows promise for stopping the immune system’s attack on insulin-producing cells in people newly diagnosed with type I diabetes, were presented at the American Diabetes Association’s Scientific Sessions. [Press release from the University of Miami Miller School of Medicine discussing online prepublications in The Lancet]

Nervous System Stem Cells Can Replace Themselves, Give Rise to Variety of Cell Types, Even Amplify
A research team has discovered in young adult mice that a lone brain stem cell is capable not only of replacing itself and giving rise to specialized neurons and glia but also of taking a wholly unexpected path: generating two new brain stem cells. [Press release from Johns Hopkins Medicine discussing online prepublication in Cell]

Magnetic Nanoparticles Fry Tumors
A team found that injecting mice with tiny magnets and cranking up the heat eliminated tumors from the animals’ bodies with no apparent side effects. [Press release from ScienceNow discussing online prepublication in Nature Nanotechnology]

Blocking Key Cell Component Could Make ‘Smart Drugs’ Effective for Many Cancer Patients
Scientists have found that blocking a key component of the DNA repair process could extend the use of a new range of ‘smart’ cancer drugs called PARP inhibitors. [Press release from Cancer Research UK discussing online prepublication in Nature Medicine]

Cellular Dynamics International Unlocks the Potential of Banked Blood Samples
Cellular Dynamics International announced demonstrating for the first time a methodology for researchers to access the biology stored in repositories of banked blood samples through the creation of induced pluripotent stem cells. [Press release from Cellular Dynamics International discussing online prepublication in Blood]

Researchers Discover New Airway Stem Cell
Researchers have identified a new stem cell that participates in the repair of the lungs’ large airways, which play a vital role in protecting the body from infectious agents and toxins in the environment. [Press release from the University of California, Los Angeles discussing online prepublication in Stem Cells]

Finding Suggests Way to Make Bladder Cancer Cells More Susceptible to Chemotherapy
Researchers have discovered a way of sensitizing muscle-invasive bladder cancer cells so that they succumb to the toxic effects of chemotherapy. [Press release from the University of California, Davis Health System discussing online prepublication in the International Journal of Cancer]

First Patients Receive Lab-Grown Blood Vessels from Donor Cells
For the first time, blood vessels created in the lab from donor skin cells were successfully implanted in patients. [Press release from ScienceDaily discussing research presented in the American Heart Association’s Emerging Science Series Webinar]

Inovio Pharmaceuticals’ DNA Vaccine for Foot-and-Mouth Disease Generates Protective Neutralizing Antibodies in Second Large-Animal Study
Inovio Pharmaceuticals, Inc. announced that it has achieved compelling immune responses in a study of its multi-subtype DNA vaccine for foot-and-mouth disease administered by Inovio’s proprietary vaccine delivery technology in sheep, the second large animal in which this vaccine was evaluated. [Press release from Inovio Pharmaceuticals, Inc. discussing research presented at the Biochemical and Molecular Engineering XVII Conference]

Two Pivotal Phase III Lucentis Studies Showed Patients with Diabetic Macular Edema Experienced Significant Improvements in Vision and Fewer Developed More Advanced Retinopathy
Genentech announced 24-month results from the two pivotal Phase III trials (RISE and RIDE) assessing the efficacy and safety of Lucentis® (ranibizumab injection) in people with diabetic macular edema. [Genentech Press Release]

Scientists ‘Mend Broken Hearts’
Tests on pigs showed that dormant heart cells could begin regrowth following a “regenerative medicine” treatment using certain growth factors. [The Telegraph]


(Ranked by Impact Factor of the Journal)

Direct Generation of Functional Dopaminergic Neurons from Mouse and Human Fibroblasts
Scientists identified a minimal set of three transcription factors—Mash1, Nurr1 and Lmx1a—that are able to generate directly functional dopaminergic neurons from mouse and human fibroblasts without reverting to a progenitor cell stage. [Nature]

Antigen-Based Therapy with Glutamic Acid Decarboxylase (GAD) Vaccine in Patients with Recent-Onset Type 1 Diabetes: A Randomized Double-Blind Trial
Researchers aimed to assess whether immunization with GAD formulated with aluminum hydroxide would preserve insulin production in recent-onset type 1 diabetes. [Lancet]

Co-Stimulation Modulation with Abatacept in Patients with Recent-Onset Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial
In this multicenter, double-blind, randomized controlled trial, patients aged 6—45 years recently diagnosed with type 1 diabetes were randomly assigned (2:1) to receive abatacept (10 mg/kg, maximum 1000 mg per dose) or placebo infusions intravenously on days 1, 14, 28, and monthly for a total of 27 infusions over 2 years. [Lancet]

In Vivo Clonal Analysis Reveals Self-Renewing and Multipotent Adult Neural Stem Cell Characteristics
Investigators developed a genetic marking strategy for lineage tracing of individual, quiescent, and nestin-expressing radial glia-like precursors in the adult mouse dentate gyrus. [Cell]

Exchange-Coupled Magnetic Nanoparticles for Efficient Heat Induction
Scientists demonstrated a significant increase in the efficiency of magnetic thermal induction by nanoparticles. [Nat Nanotechnol]

Compromised CDK1 Activity Sensitizes Breast Cancer–Associated-Proficient Cancers to Poly(ADP-Ribose) Polymerase Inhibition
Researchers showed that depletion or inhibition of cyclin-dependent kinase 1 (Cdk1) compromises the ability of cells to repair DNA by homologous recombination. [Nat Med]

Dissecting the Oncogenic Potential of Human Embryonic and Induced Pluripotent Stem Cell Derivatives
In this study, investigators analyzed the gene expression patterns from three sets of human induced pluripotent stem cell- and human embryonic stem cell- derivatives and the corresponding primary cells, and compared their transcriptomes with those of five different types of cancer. [Cancer Res]



Stem-Cell Scientists Grapple with Clinics
In the face of legal threats from clinics, the International Society for Stem Cell Research has suspended a service intended to help patients wade through claims about therapies. [International Society for Stem Cell Research, United States]

DeGette Reintroduces Stem Cell Bill
In what may be an exercise in futility, Representative Diana DeGette reintroduced her bill that would codify the Obama Administration’s 2009 policy easing restrictions on federally funded research on human embryonic stem cells. [Congress, United States]

California Universities Brace for More Cuts
Facing a persistent budget gap, the California legislature passed an austere budget that will bring yet more financial pain to the already cash-strapped state university system. [California Legislation, United States]

Fallout from Strauss-Kahn Affair: France Gets New Research Minister
One ripple effect of the arrest in New York of former International Monetary Fund Managing Director Dominique Strauss-Kahn on charges of sexual assault is that a shuffling of seats in the French cabinet has led to a new minister for higher education and research being appointed. [French Cabinet, France]

Italy’s Funds for HIV/AIDS Research Running Dry
Despite Italian HIV/AIDS researchers earning a top tier berth in the field, the government has no plans to continue the National AIDS Research Program that, at its peak in the 1990s, received €25 million a year. [Istituto Superiore di Sanità, Italy]


AstraZeneca and PTC Therapeutics Announce Strategic Oncology Drug Discovery Collaboration with Potential Extension to Other Therapeutic Areas
AstraZeneca and PTC Therapeutics, Inc. announced that they have entered into an exclusive research collaboration and license agreement for the application of PTC’s proprietary GEMS™ technology for the discovery and development of potential new therapies for cancer and other diseases for which there is a great unmet medical need. [PTC Therapeutics, Inc. Press Release]

Innovative Vaccines with Nanotechnology
The German Helmholtz Centre for Infection Research and its department “Vaccinology and Applied Microbiology” is now a part of the transnational consortium with researchers from Germany, France and Switzerland. [German Helmholtz Centre for Infection Research Press Release]

Personalized Medicine on the Horizon for BC Cancer Patients
Genome British Columbia and the BC Cancer Foundation have joined forces to announce a major step forward in applying the power of genomics to personalized medicine. [Genome British Columbia Press Release]

Scripps Institutions Join National Tumor Consortium
The Scripps Research Institute, Scripps Health, and Scripps Translational Science Institute have announced they have joined a national consortium of research institutions headed by The Jackson Laboratory that is building a library of primary human tumors with the goal of developing highly targeted cancer therapies. [Scripps Research Press Release]

Rare-Disease Studies Seek Online Giving
Those wanting to raise awareness about a rare disease will be able to take advantage of an initiative being launched later: a website that connects research projects with members of the public who can donate just a few dollars to help to develop cures. [NatureNews]

Li Ka Shing Foundation Makes $1.5 Million Donation to Boost Yale Stem Cell Research
The Li Ka Shing Foundation has awarded $1.5 million to Yale University to expand two research core facilities, the human embryonic stem cell core and the genomics core, of the Yale Stem Cell Center. [Yale Office of Public Affairs & Communications Press Release]

Scripps Receives $7.9 Million NIH Grant for Novel ‘Disease in a Dish’ Genomic Research into Finding Root Cause of Heart Attack
The National Institutes of Health (NIH) has awarded a $7.9 million grant to the Scripps Translational Science Institute and Sangamo BioSciences to conduct the nation’s first-ever, heart-based “disease in a dish” research. [The Scripps Research Institute Press Release]

Husson University Receives Cancer Research Grant
Dr. Shuhua Bai, assistant professor in Husson University’s School of Pharmacy, has received a $69,000 grant from the Maine Cancer Foundation. [Husson University Press Release]

United States FDA Clears Mesoblast Phase II Trial to Treat Degenerative Disc Disease
Mesoblast Limited announced that it has received clearance from the United States Food and Drug Administration (FDA) to begin a Phase II clinical trial of its proprietary adult Mesenchymal Precursor Cell product for the treatment of degenerative disc disease. [Mesoblast Limited Press Release]

Scancell Develops New Vaccine for the Treatment of Lung Cancer
Scancell Holdings Plc announced that a treatment utilizing a DNA vaccine based on its ImmunoBody® technology, in combination with Homspera®, an adjuvant developed by ImmuneRegen BioSciences, Inc.® has produced encouraging anti-tumor results in animal models. [Scancell Holdings Plc Press Release]

ACT Granted EU Orphan Medicinal Product Designation for hESC-Derived RPE Cells for Treatment of Stargardt’s Disease
Advanced Cell Technology, Inc. (ACT) announced that the European Medicines Agency’s Committee for Orphan Medicinal Products has officially granted ACT’s human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells designation as an orphan medicinal product for the treatment of Stargardt’s Macular Dystrophy. [Advanced Cell Technology, Inc Press Release]

Aastrom Establishes Independent Steering Committee for REVIVE Phase III CLI Clinical Program 
Aastrom Biosciences, Inc. announced the formation of an independent steering committee to support the REVIVE Phase III clinical program for ixmyelocel-T. [Aastrom Biosciences, Inc. Press Release]

Researchers to Present Results from Two VIRxSYS HIV Studies at the 6th International AIDS Society Meeting
VIRxSYS Corporation announced that data from two HIV studies will be presented at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, July 17 to 20, 2011. [Marketwire]


NIH Program on Undiagnosed Diseases Overwhelmed with Cases
The Undiagnosed Diseases Program will temporarily stop accepting new applications for cases to be studied because of an “overwhelming number of applications already received,” according to the note posted on the program’s Web site.

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-16363)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-16464)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-16532)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-16534)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-16615)


2011 Advisory Committee Tentative Meetings

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)



Breast Cancer Drug Gets a Unanimous Thumbs Down
An advisory committee to the U.S. Food and Drug Administration sided with the agency, agreeing in a unanimous vote, 6-0, that the drug Avastin should not be approved for breast cancer.

Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall Regulations [Docket No. FDA-2011-N-0439]

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting [Docket No. FDA-2011-N-0002]


European Network of Centres for Pharmacoepidemiology and Pharmacovigilance Sees Rapid Growth
The seventh plenary meeting of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance has heard that the network has grown considerably over the past few months, with over 100 resources from 17 different European countries now registered.

European Medicines Agency’s 2010 Annual Report Shows Increase in Activities
The European Medicines Agency maintained its levels of efficiency and effectiveness during 2010, despite increases in workload across almost all areas, according to its 2010 annual report.

European Medicines Agency Hosts Meeting with European Parliament Representatives
A delegation from the European Parliament’s Committee on the Environment, Public Health and Food Safety has visited the European Medicines Agency to hear an update on its activities.

European Medicines Agency Publishes Format for Submission of Information on Medicines
The European Medicines Agency reached the first milestone in the implementation of the new pharmacovigilance legislation, by publishing the format in which pharmaceutical companies need to submit information on all of the medicines authorized or registered in the European Union.


Evaluation of a New Medicine – The TGA’s Lifecycle Approach to Regulation
The TGA aims to ensure that the community has access to therapeutic advances within a reasonable timeframe.

Orphan Drugs
Added axitinib, vemurafenib, erlontinib, imatinib mesylate, ecallantide, pazopanib to the list of designated orphan drugs

Summary of Fees and Charges at 1 July 2011
Summary of TGA fees and charges for the 2011-2012 financial year.


NEW Drug Discovery Global Summit
July 26-27, 2011
London, United Kingdom

NEW Cancer Research Global Summit
August 16-17, 2011
London, United Kingdom

NEW Cold Spring Harbor – Harnessing Immunity to Prevent and Treat Disease
November 16-19, 2011
Cold Spring Harbor, United States

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


Chemist (STEMCELL Technologies)

Research and Development Senior Technologist (STEMCELL Technologies)

Lab Technologist – Tissue Culture (Maternity Leave) (STEMCELL Technologies)

Research and Development Technologist, hPSC Media (STEMCELL Technologies)

Scientist (iPSC) (STEMCELL Technologies)

Medical Officer (California Institute for Regenerative Medicine)

Postdoctoral Position (University of California, Davis)

Director, Cell Processing Operations (Hospira Industry)

PhD Scholarship (Tasmania University)

Postdoctoral Fellow (Roswell Park Cancer Institute)

Industrial Postdoctoral Research Fellow (Regenerative Medicine Cell Therapy) (Tissue Regeneration Therapeutics Inc.)

Research Laboratory Technician (Cambridge Centre for Brain Repair)

Postdoctoral Research Fellow (Tshwane University of Technology)

Senior Research Fellowship (Masaryk University)

Junior Research Fellowship (Masaryk University)

Reintegrating/Czech Nationality/ Research Fellowship (Masaryk University)

Microscopy and Image Analysis Specialist (Masaryk University)

PhD Positions in Stem Cell Research (Masaryk University)

PhD Positions in Medical Biology (Masaryk University)

Postdoctoral Fellow – Stem Cell Biology and Immunology (NIH Center for Biomedical Research Excellence)

Graduate Student – Laboratory for Equine and Comparative Orthopedic Research (Louisiana State University)

Postdoctoral Fellow (University of California, Los Angeles)

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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