Volume 12.24 | Jun 20

Cell Therapy News 12.24, June 20, 2011
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
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TOP STORY

Working in Harmony: MIT-Designed Nanoparticles Communicate with Each Other Inside the Body to Target Tumors More Efficiently
A team of researchers has designed a new type of delivery system in which a first wave of nanoparticles homes in on the tumor, then calls in a much larger second wave that dispenses the cancer drug. [Press release from the Massachusetts Institute of Technology discussing online prepublication in Nature Materials]

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SCIENCE NEWS

New Approach to Cancer Vaccines Proves Successful in Early Studies
Researchers have used a library of DNA to create a vaccine that could be used to treat cancer, according to a study. [Press release from the University of Leeds discussing online prepublication in Nature Medicine]

Promising New Target for Stifling the Growth and Spread of Cancer
Researchers said they’ve identified a tumor inflammation trigger that is common to most, if not all, cancers. And using existing inhibitory drugs, the scientists were able to dramatically decrease primary tumor growth in animal studies and halt tumor progression and metastasis. [Press release from the University of California, San Diego discussing online prepublication in Cancer Cell]

Sniffing Out a New Source of Stem Cells
New research in mice suggests that adult stem cells from immune system tissue in the smell-sensing region of the human nose (human olfactory ecto–mesenchymal stem cells) could provide a source of cells to treat brain disorders in which nerve cells are lost or irreparably damaged. [Press release from ScienceDaily discussing online prepublication in the Journal of Clinical Investigation]

Glowing Cornell Dots – A Potential Cancer Diagnostic Tool Set for Human Trials
The U.S. Food and Drug Administration has approved the first clinical trial in humans of a new technology: Cornell Dots, brightly glowing nanoparticles that can light up cancer cells in PET-optical imaging. [Press release from Cornell University discussing online prepublication in the Journal of Clinical Investigation]

New Genetic Technique Converts Skin Cells into Brain Cells
A research breakthrough has proven that it is possible to reprogram mature cells from human skin directly into brain cells, without passing through the stem cell stage. [Press release from Lund University discussing online prepublication in the Proceedings of the National Academy of Sciences United States]

Stem Cells from Patients Make ‘Early Retina in a Dish’
Soon, some treatments for blinding eye diseases might be developed and tested using retina-like tissues produced from the patient’s own skin, thanks to a series of discoveries reported by a team of stem cell researchers. [Press release from the University of Wisconsin-Madison discussing online prepublication in Stem Cells]

Researchers Discover Target Molecule to Repair Injured Nerve Cells
A team of investigators has discovered that a factor in the embryonic development of brain cells is an important target for developing new drugs and stem cell therapies to treat patients who have lost function from multiple sclerosis, cerebral palsy, stroke and other “demyelinating” diseases and injuries. [Press release from the University of California, Davis discussing online prepublication in Scientific Reports]

Get Rid of Sex Hormones, Boost Organ Transplant Tolerance
Drugs that suppress the production of sex hormones could help induce transplant tolerance in elderly patients, reports a new study in mice. [Press release from EurekAlert! discussing online prepublication in Science Translational Medicine]

Low Levels Of Iron-Binding Protein May Mean Better Outcome After Stem Cell Transplant For MDS (ASCO 2011)
Myelodysplastic syndromes (MDS) patients who have low levels of an iron-binding protein prior to stem cell transplantation may have longer survival after the procedure than those with high levels of the protein. [Press release from The MDS Beacon discussing research presented at the 47th Annual Meeting of the American Society of Clinical Oncology]

Latest Data from Cedars-Sinai Vaccine Study Supports Immune Targeting of Brain Tumors
An experimental vaccine developed by researchers targets overactive antigens in highly aggressive brain tumors and improves length of survival in newly diagnosed patients. [Press release from Cedars-Sinai discussing research presented at the 47th Annual Meeting of the American Society of Clinical Oncology]

Nerve Cells Grown from Stem Cells Give Insight into Parkinson’s
Researchers have succeeded in using stem cell technology to grow nerve cells in the laboratory from initial skin samples taken from Parkinson’s patients. [University of Oxford Press Release]

Engineers Control the Environment to Direct Stem Cell Differentiation
New research presented shows that systematically controlling the local and global environments during stem cell development helps to effectively direct the process of differentiation. [Press release from Georgia Tech discussing research presented at the International Society for Stem Cell Research]

Patients Still Being Enrolled in Clinical Trial for New Peripheral Vascular Disease Treatment
The “TGI-PVG IDE” clinical trial initiated at the University of Louisville involves using a patient’s own stem cells to line man-made bypass grafts to better the chances at saving the limbs of patients with peripheral artery disease. [University of Louisville Press Release]

UC Davis Testing Alternative Approach to Treating Non-Healing Bone Fractures
A method for producing a type of natural stem-cell grout that can be used to treat patients whose fractured bones fail to fully heal is being tested as part of a clinical trial. [University of California, Davis Press Release]

Echocardiography Shows Promise in Guiding Gene Therapy for Disease Prevention and Treatment
Researchers announced the results of a study that show echocardiography can improve the success rate of gene therapy and increase growth, function and sustainability of regenerated vessels. [PR Newswire Press Release]

First Patients Are Vaccinated in IMPRINT*, Immatics’ Pivotal Phase III Trial with IMA901 in Patients with Renal Cell Carcinoma
immatics biotechnologies GmbH announced that the first patients have been vaccinated in the IMPRINT study, a pivotal Phase III trial with IMA901, the company’s lead cancer vaccine for the treatment of renal cell carcinoma. [immatics biotechnologies GmbH Press Release]

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CURRENT PUBLICATIONS
(Ranked by Impact Factor of the Journal)

Nanoparticles that Communicate In Vivo to Amplify Tumor Targeting
Inspired by the ability of communication to improve targeting in biological systems, such as inflammatory-cell recruitment to sites of disease, investigators constructed systems where synthetic biological and nanotechnological components communicate to amplify disease targeting in vivo. [Nat Mater]

Broad Antigenic Coverage Induced by Vaccination with Virus-Based cDNA Libraries Cures Established Tumors
Scientists show here that a cDNA library of normal tissue, expressed from a highly immunogenic viral platform, cures established tumors of the same histological type from which the cDNA library was derived. [Nat Med]

Receptor Tyrosine Kinases and TLR/IL1Rs Unexpectedly Activate Myeloid Cell PI3Kγ, A Single Convergent Point Promoting Tumor Inflammation and Progression
Researchers found that a range of chemoattractants activating G protein-coupled receptors, receptor tyrosine kinases and Toll-like/IL-1 receptors (TLR/IL1Rs) unexpectedly initiate tumor inflammation by activating the PI3-kinase isoform p110γ in Gr1+CD11b+ myeloid cells. [Cancer Cell]

Engraftment of Human Nasal Olfactory Stem Cells Restores Neuroplasticity in Mice with Hippocampal Lesions
Investigators reported that upon transplantation into mice with chemically induced hippocampal lesions, human olfactory ecto–mesenchymal stem migrated toward the sites of neural damage, where they differentiated into neurons. [J Clin Invest]

Multimodal Silica Nanoparticles Are Effective Cancer-Targeted Probes in a Model of Human Melanoma
Scientists described their full characterization of an approximately 7-nm diameter multimodal silica nanoparticle, exhibiting what they believed to be a unique combination of structural, optical, and biological properties. [J Clin Invest]

Direct Conversion of Human Fibroblasts to Dopaminergic Neurons
Recent reports demonstrated that somatic mouse cells can be directly converted to other mature cell types by using combined expression of defined factors. Here researchers showed that the same strategy can be applied to human embryonic and postnatal fibroblasts. [Proc Natl Acad Sci U S A]

Optic Vesicle-Like Structures Derived from Human Pluripotent Stem Cells Facilitate a Customized Approach to Retinal Disease Treatment
Investigators demonstrated that three-dimensional populations of retinal progenitor cells can be isolated from early forebrain populations in both human embryonic stem cell and human induced pluripotent stem cells cultures, providing a valuable tool for developmental, functional, and translational studies. [Stem Cells]

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POLICY

Europe Tackles Huge Fraud
Italian authorities and the European Anti-Fraud Office in Brussels, Belgium, have confirmed that they are prosecuting members of a large network accused of pocketing more than €50 million (US$72 million) in European Commission grants for fake research projects. [European Anti-Fraud Office, Belgium]

Government Accepts NHS Reform Changes, Including Commitments to Research and Clinical Networks
The government has accepted the main recommendations made by the independent National Health Service (NHS) Future Forum, a group of health experts and patient representatives who were asked to oversee the recent NHS listening exercise. [National Health Service, United Kingdom]

Egypt Invests in its Science
On 1 June, the Egyptian cabinet approved the first post-revolution budget, which boosted science despite the severe social and economic crises gripping the country. [Egyptian Cabinet, Egypt]

Fight Erupts Over New Bosniak Academy of Sciences
A new academy of science started by Muslim religious leaders in Bosnia and Serbia has stirred debate across the Balkans. Serbian academics say the academy is a political move aimed at increasing tensions between Serbs and Bosniaks in the region, and some Bosniak scientists say the new organization is an attempt by Muslim clerics to increase their influence that adds little to the existing academies of science in the region. [Bosniak Academy of Sciences, Bosnia]


BUSINESS

Fox Chase Cancer Center Signs Agreement with Life Technologies Corporation
Fox Chase Cancer Center announced it has entered into an agreement with Life Technologies Corporation that will underpin a new program to provide next-generation sequencing analysis of solid tumors. [Fox Chase Cancer Center Press Release]

Sanofi Enters into Research Collaboration with Biopharmaceutical Company Audion Therapeutics to Develop Potential Treatments for Hearing Loss
Sanofi announced that it has entered into a two-year research collaboration with the biopharmaceutical company Audion Therapeutics to develop potential treatments for hearing loss through the optimization of small molecules by using a regenerative medicine approach. [Sanofi Press Release]

National Eye Institute Awards Cedars-Sinai $3 Million to Develop Gene, Stem Cell Therapies for Corneal Disease
Cedars-Sinai stem cell researchers investigating ways to prevent eye problems in diabetic patients have been awarded a $3 million grant from the National Eye Institute to develop gene therapy in corneal stem cells to alleviate damage to corneas that can cause vision loss. [Cedars-Sinai Press Release]

BrainStorm Initiates Clinical Trials and Holds Successful Shareholders Meeting
BrainStorm Cell Therapeutics announced that together with the Hadassah Medical Organization, a successful study initiation/clinical trial kickoff meeting was held at the Hadassah Medical Center and with this meeting the trial is underway. [BrainStorm Cell Therapeutics Press Release]

Adaptimmune Announces Opening of Phase I/II Clinical Trial for Metastatic Melanoma
Adaptimmune announced that it has opened a Phase I/II, two cohort, open label clinical trial in metastatic melanoma at Washington University. [Adaptimmune Press Release]

ACT Announces First Patients Enrolled in Two Clinical Trials Using Embryonic Stem Cells to Treat Stargardt’s Disease and Dry Age-Related Macular Degeneration
Advanced Cell Technology, Inc. (ACT) announced the enrollment of the first patients in its two Phase I/II clinical trials for Stargardt’s Macular Dystrophy and Dry Age-Related Macular Degeneration using retinal pigment epithelial cells derived from human embryonic stem cells. [Advanced Cell Technology, Inc. Press Release]

Alnylam Appoints Akshay Vaishnaw as Chief Medical Officer
Alnylam Pharmaceuticals, Inc. announced that it has promoted Akshay K. Vaishnaw, M.D., Ph.D., to the new position of Chief Medical Officer. [Alnylam Pharmaceuticals, Inc. Press Release]

Micromet Appoints Ulrich Grau, Ph.D. Executive Vice President and Chief Operating Officer
Micromet, Inc. announced the appointment of Ulrich Grau, Ph.D., as Executive Vice President, Chief Operating Officer. [Micromet, Inc. Press Release]

King’s Appoints Stem Cell Expert to Lead New Center
King’s College London announced that it is set to launch a Centre for Stem Cells & Regenerative Medicine to be led by Professor Fiona Watt, former president of the International Society of Stem Cell Research. [King’s College London Press Release]

New Centre to Drive Commercialization of Regenerative Medicine
A network of Canadian scientists, entrepreneurs and industry partners launched a new centre aimed at translating regenerative medicine science into marketable products that will revolutionize medicine. [The Centre for Commercialization of Regenerative Medicine Press Release]

Nuvilex Enters Discussions to Acquire Next Generation Technology to Treat Multiple Types of Cancer
Nuvilex, Inc. announced it has entered into discussions to acquire the next generation live cell encapsulation technology that serves as the platform for multiple cancer therapies. [Nuvilex, Inc. Press Release]

NUI Galway, UL and UCC Partner in PhD Program
Research in the area of Biomedical Engineering and Regenerative Medicine will be furthered through the launch of a structured PhD Program in the field delivered through the National University of Ireland (NUI) Galway/UL Strategic Alliance and University College Cork (UCC). [National University of Ireland Galway Press Release]

Stem Cell Scientific Leader Awarded Prestigious Taylor Prize
The University of Western Ontario announced this year’s recipient of the J. Allyn Taylor International Prize in Medicine is Dr. Rudolf Jaenisch, a founding member of the Whitehead Institute for Biomedical Research and Professor of Biology at the Massachusetts Institute of Technology. [University of Western Ontario Press Release]

UCSF Stem Cell, Cancer Scientist Honored for Pioneering Studies
University of California, San Francisco (UCSF)’s Robert Blelloch, MD, PhD, has received the 2011 Outstanding Young Investigator Award from the International Society for Stem Cell Research, for his pioneering research on the role of molecular tools known as microRNAs in embryonic stem cells and cancer. [University of California, San Francisco Press Release]


NIH

Greenberg Named Acting Director of the National Institute of General Medical Sciences
Judith H. Greenberg, Ph.D., will become the acting director of the National Institutes of Health’s National Institute of General Medical Sciences.

NIH Expands Reach of National Clinical and Translational Research Consortium
The National Institutes of Health announced that it will provide $200 million over five years to five health research centers to speed scientific discoveries into treatments for patients.

NIH Intervenes in Alzheimer’s Mouse Lawsuit
The US National Institutes of Health has leapt to the rescue of a laboratory that was sued for distributing mouse models to researchers.

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-14688)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-14689)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-14693)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-14716)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-14872)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-1473)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-15005)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-15012)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-15093)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-15095)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-15289)

Center for Scientific Review; Cancellation of Meeting (FR Doc No: 2011-14690)

Center for Scientific Review; Amended Notice of Meeting (FR Doc No: 2011-14694)

Office of the Director; Notice of Charter Renewal for the Advisory Committee to the Director (FR Doc No: 2011-15006)

National Human Genome Research Institute; Notice of Closed Meeting (FR Doc No: 2011-14876)

National Human Genome Research Institute; Notice of Closed Meeting (FR Doc No: 2011-15011)

National Institute of General Medical Sciences; Notice of Closed Meeting (FR Doc No: 2011-14865)


CBER
June 29, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Briefing Document

June 29, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Draft Agenda

REGULATORY

FOOD AND DRUG ADMINISTRATION (United States)

FDA Unveils New Global Strategy to Help Ensure Safety and Quality of Imported Products
The U.S. Food and Drug Administration unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”

Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Availability [Docket No. FDA-2010-D-0530]

Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Availability [FR Doc No: 2011-15089]


Oncologic Drugs Advisory Committee; Notice of Meeting [FR Doc No: 2011-15019]

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees [FR Doc No: 2011-15045]

Innovation for HIV Vaccine Discovery (R01) [RFA-AI-11-018]

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice [Docket No. FDA-2011-N-0447]

EUROPEAN MEDICINES AGENCY (European Union)

European Medicines Agency and US Food and Drug Administration Receive First Parallel Quality-By-Design Application
The European Medicines Agency and the United States Food and Drug Administration have agreed to accept the first application under their pilot program for the parallel evaluation of marketing-authorization applications involving ‘quality by design’.


MEDICINES AND HEALTHCARE REGULATORY AGENCY (United Kingdom)

MHRA Chief Executive, Professor Kent Woods, Receives a Knighthood
The MHRA Chief Executive, Professor Kent Woods, has been awarded a knighthood in the Queen’s Birthday Honours List 2011 for his services to healthcare.

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Clinical Guidelines
European Union guidelines adopted in Australia

Australia New Zealand Therapeutic Products Agency
The Australian and New Zealand Governments have agreed to proceed with a joint scheme for regulation of therapeutic goods.


EVENTS
NEW Vaccine Forum Singapore 2011
September 19-21, 2011
Singapore

NEW Mouse Molecular Genetics
September 20-23, 2011
Hinxton, United Kingdom

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

JOB OPPORTUNITIES

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)

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)

Post Doctoral Fellow (University of California, Los Angeles)

Staff Scientist Position (Spanish National Cancer Center)

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

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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