Volume 12.11 | Mar 21

Cell Therapy News 12.11, March 21, 2011.
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
 
TOP STORY

Researchers Create Organic, Non-Toxic Nanoparticle
A team of scientists has created an organic nanoparticle that is completely non-toxic, biodegradable and nimble in the way it uses light and heat to treat cancer and deliver drugs. [Press release from the University Health Network discussing online prepublication in Nature Materials]

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SPECIAL FEATURE

Webinar: ALDHbr Cells and Regenerative Medicine

Aldehyde Dehydrogenase bright (ALDHbr) cells have been used in preclinical models and human clinical trials in applications such as critical limb ischemia, ischemic stroke, acute liver failure and ischemic heart failure.1 Learn more about how ALDHbr cells could be used in regenerative medicine by registering today for an exclusive webinar presented by Dr. Andrew E. Balber of Cicada Biopharmaceutical Consulting.

Join us on April 7 at:
10AM EST (ideal for Europe) | 2PM EST (ideal for Americas) | 8PM EST (ideal for Asia-Pacific)


1
Reviewed in Balber AE. Stem Cells (in press). DOI: 10.1002/stem.613.

Dr. Balber holds equity in and is a consultant to Aldagen, Inc., a company that is developing research, diagnostic, and therapeutic products based on detecting and isolating ALDHbr cells.



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SCIENCE NEWS

Scientist Helps Revisit “Hallmarks of Cancer”
Renowned cancer researchers Robert Weinberg and Douglas Hanahan have updated their seminal review, “Hallmarks of Cancer,” which has influenced the study of cancer and the development of therapeutics for more than a decade. [Press release from the Whitehead Institute for Biomedical Research discussing online prepublication in Cell]

New Method Delivers Alzheimer’s Drug to the Brain
Scientists have developed a new method for delivering complex drugs directly to the brain. The team has successfully switched off a gene implicated in Alzheimer’s disease in the brains of mice by exploiting exosomes. [Press release from the University of Oxford discussing online prepublication in Nature Biotechnology]

Gene Therapy Reverses Symptoms of Parkinson’s Disease
A gene therapy called NLX-P101 dramatically reduces movement impairment in Parkinson’s patients, according to results of a Phase II study. The approach introduces a gene into the brain to normalize chemical signaling. [Press release from Weill Cornell Medical College discussing online prepublication in The Lancet Neurology]

Team Creates Stem Cells from Schizophrenia Patients
Using skin cells from adult siblings with schizophrenia and a genetic mutation linked to major mental illnesses, researchers have created induced pluripotent stem cells using a new and improved “clean” technique. [Press release from Johns Hopkins Medicine discussing online prepublication in Molecular Psychiatry]

Scientists Discover Class of Potent Anti-Cancer Compounds
Working as part of a public program to screen compounds to find potential medicines and other biologically useful molecules, scientists from The Scripps Research Institute and Massachusetts Institute of Technology have discovered an extremely potent class of potential anti-cancer and anti-neurodegenerative disorder compounds. [Press release from The Scripps Research Institute discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

Study First to Show Stem Cell Injections Reduce Heart Damage and Improve Function
Stem cell researchers have shown for the first time that stem cells injected into enlarged hearts reduced heart size, reduced scar tissue and improved function to injured heart areas. [Press release from the University of Miami Miller School of Medicine discussing online prepublication in Circulation Research]

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

Vaccine Made with Synthetic Gene Protects Against Deadly Pneumonia
Researchers have developed an experimental vaccine that appears to protect against an increasingly common and particularly deadly form of pneumococcal pneumonia. [Press release from the Albert Einstein College of Medicine of Yeshiva University discussing online prepublication in the Journal of Infectious Diseases]

Transmissible Gene Therapy Treatment Proposed for HIV to Curb Epidemic
Engineered, virus-like particles that would latch onto HIV, exploit its genes, stop it from replicating and then get transmitted in the same way as HIV are being proposed as a new way of stopping the epidemic. [Press release from AidsMap discussing online prepublication in PLoS Computational Biology]

Nanomaterials Used to Trap Cancer Stem Cells
When prostate cancer stem cells were enclosed in self-assembling nanomaterials made of peptides (SAP), the SAP stopped cancer stem cell colony formation and also stopped the division of cancer cells in laboratory cultures. [Press release from Drug Discovery & Development Magazine discussing online prepublication in Cell Transplantation]

Laser Beam Makes Cells “Breathe In” Water and Potentially Anti-Cancer Drugs
Shining a laser light on cells and then clicking off the light-makes the cells “breathe in” surrounding water, providing a potentially powerful delivery system for chemotherapy drugs, as well as a non-invasive way to target anti-Alzheimer’s medicines to the brain. [Press release from the American Chemical Society discussing online prepublication in the Journal of Physical Chemistry Letters]

Oxford BioMedica Announces Publication of TroVax® Phase III Analyses in Cancer Immunology, Immunotherapy
Oxford BioMedica plc announced that further analyses of the TroVax® Renal Immunotherapy Survival Trial, a randomized, double-blind, placebo-controlled Phase III study, have been accepted for publication. [Press release from Oxford BioMedica plc discussing online prepublication in Immunotherapy]

Liquid Biomaterials Take Stem Cell Therapy to New Level
Researchers are investigating the possibilities of a biologically-engineered synthetic liquid polymer that would eliminate the need for further surgery by offering a one stop, permanent solution. [University of Bristol Press Release]

Modified mRNA Is the Key to Novel Anti-Cancer Therapy
Researchers have developed and patented methods for increasing mRNA stability and enhancing its productivity in the production of therapeutic proteins. [Faculty of Physics, University of Warsaw Press Release]

UC Davis Launches Stem Cell Study to Reduce Amputations from Vascular Disease and Diabetes
University of California (UC), Davis Vascular Center researchers have embarked on a highly anticipated study that involves using a patient’s own stem cells to increase blood circulation to the lower leg with the hope of preventing amputation due to severe arterial disease or diabetes. [University of California, Davis Health System Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Hallmarks of Cancer: The Next Generation
The hallmarks of cancer constitute an organizing principle for rationalizing the complexities of neoplastic disease. Conceptual progress in the last decade has added two emerging hallmarks of potential generality to this list – reprogramming of energy metabolism and evading immune destruction. [Cell]

Porphysome Nanovesicles Generated by Porphyrin Bilayers for Use as Multimodal Biophotonic Contrast Agents
Researchers report the development of porphysomes; nanovesicles formed from self-assembled porphyrin bilayers that generated large, tunable extinction coefficients, structure-dependent fluorescence self-quenching and unique photothermal and photoacoustic properties. [Nat Mater]

Delivery of siRNA to the Mouse Brain by Systemic Injection of Targeted Exosomes
Researchers show that exosomes can deliver short interfering (si) RNA to the brain in mice. [Nat Biotechnol]

Isolation of Epiblast Stem Cells from Preimplantation Mouse Embryos
Researchers show that epiblast stem cells can be routinely derived from pre-implantation mouse embryos. [Cell Stem Cell]

AAV2-GAD Gene Therapy for Advanced Parkinson’s Disease: A Double-Blind, Sham-Surgery Controlled, Randomized Trial
The efficacy and safety of bilateral infusion of AAV2-GAD in the subthalamic nucleus supports its further development for Parkinson’s disease and shows the promise for gene therapy for neurological disorders. [Lancet Neurol]

Integration-Free Induced Pluripotent Stem Cells Derived from Schizophrenia Patients with a DISC1 Mutation
Induced pluripotent stem cells, reprogrammed from somatic cells of healthy subjects and patients, offer an unprecedented opportunity to recapitulate both normal and pathologic human development, thereby enabling a new approach to understanding human disease mechanisms. [Mol Psychiatry]

Academic Cross-Fertilization by Public Screening Yields a Remarkable Class of Protein Phosphatase Methylesterase-1 Inhibitors
Researchers have combined advanced synthetic and chemoproteomic methods to discover a class of aza-β-lactam inhibitors that can be used to selectively perturb phosphatase methylesterase-1 activity in diverse biological systems. [Proc Natl Acad Sci U S A]

Intramyocardial Stem Cell Injection in Patients with Ischemic Cardiomyopathy
Data suggest that transcatheter, intramyocardial injections of autologous bone marrow progenitor cells improve regional contractility of a chronic myocardial scar, and these changes predict subsequent reverse remodeling. [Circ Res]

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]

Using Self-Assembled Nanomaterials to Inhibit the Formation of Metastatic Cancer Stem Cell Colonies In Vitro
Findings suggest that self-assembled peptide can completely inhibit a prostate cancer stem cell (CSC) from self-renewal while preserving its viability and CSC property. [Cell Transplant]

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POLICY

Recommendations to the Review of the Legislation Governing the Use of Human Embryos in Research
The Australian Stem Cell Centre (ASCC) has submitted its recommendations to the independent committee reviewing the Australian legislation governing the use of human embryos in research. The ASCC’s submission makes a series of recommendations in support of the current regulatory framework and the ongoing requirement for Australian scientists to be able to apply for a license to derive new human embryonic stem cells for use in research. [Australian Stem Cell Centre, Australia]

Gene Patent Bill Threatens Research, Does Not Tackle Community Concerns
Proposed changes to Australia’s gene patenting laws will not address legitimate community concerns around the patenting of genes and could have unintended and damaging consequences for both scientists and the community, the head of Business Development at the Walter and Eliza Hall Institute, Dr Julian Clark, explains. [Senate, Australia]

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BUSINESS

UMass, U.K. Stem Cell Banks Sign Agreement
As part of Governor Deval Patrick’s Innovation Economy Partnership Mission 2011, global leaders in the field of stem cell banking and characterization—the University of Massachusetts (UMass) Human Stem Cell Bank and Registry and the United Kingdom Stem Cell Bank—signed an agreement to share best practices for stem cell banking and to collaborate on standards for stem cell line characterization, production and distribution in the U.S. and U.K. [University of Massachusetts Medical School Press Release]

Cellectis and the Etablissement Français du Sang Launch StemRed, a Program to Produce Red Blood Cells from Stem Cells
Cellectis and Etablissement Français du Sang announce that StemRed, an ambitious collaborative program to produce red blood cells from induced pluripotent stem cells has started. [Cellectis Press Release]

Seattle Genetics and Millennium Expand Antibody-Drug Conjugate Collaboration
Seattle Genetics, Inc. announced that Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, has paid an undisclosed fee to exercise an option to designate a second antigen target under the parties’ existing antibody-drug conjugate collaboration. [Seattle Genetics, Inc. Press Release]

Human Genome Sciences and Fiveprime Therapeutics Announce Development and Commercialization Agreement for Novel Anti-Cancer Drug
Human Genome Sciences, Inc. and FivePrime Therapeutics, Inc. announced that they have entered into an agreement to develop and commercialize FivePrime’s FP-1039 product for multiple cancers. [FivePrime Therapeutics Inc. Press Release]

Curis Announces Positive Results in Genentech Pivotal Phase II Clinical Trial of GDC-0449 in Advanced Basal Cell Carcinoma
Curis, Inc. announced a positive outcome from a pivotal Phase II clinical trial conducted by Roche and Genentech, Curis’ collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class hedgehog pathway inhibitor, in patients with advanced basal cell carcinoma. [Curis, Inc. Press Release]

Pluristem Therapeutics and NYU Medical Center Partner to Study Use of PLX Cells in Treatment of Diabetic Foot Ulcers
Pluristem Therapeutics, Inc. and New York University Medical Center announced the formation of a partnership to study the use of Pluristem’s proprietary placenta-derived PLX cells for the treatment of Diabetic Foot Ulcers. [Pluristem Therapeutics, Inc. Press Release]

bluebird bio Awarded up to $4.2 Million from the French Muscular Dystrophy Association for Continued Development of Gene Therapy for Beta-Thalassemia and Sickle Cell Anemia
bluebird bio announced that it has entered into an agreement with the French Muscular Dystrophy Association, a French non-profit entity, whereby the company will receive an initial amount of approximately $1.4 million in cash to support the development of LentiGlobin®, the company’s development-stage program for the treatment of beta-thalassemia and sickle cell anemia. [bluebird bio Press Release]

Funding Boost for Synthetic Blood Research
Work by researchers from the University of Glasgow who are developing synthetic human blood has been given a huge funding boost. The Scottish Funding Council are providing £2.5million over the next five years to help fund the work. [University of Glasgow Press Release]

Federal Funding Enables CDRD’s Biologics Capabilities
The Centre for Drug Research and Development (CDRD) and Western Economic Diversification Canada, announced $900,000 in Government of Canada support for the CDRD to establish a leading-edge Biologics Division at its research facilities located on the University of British Columbia campus. [Centre for Drug Research and Development Press Release]

Important Funding for Nanomedicine Research to Improve Diagnosis and Treatment
Seven new research projects on regenerative medicine and nanomedicine received $16 million in funding. [Canadian Institutes of Health Research Press Release]

Oxford BioMedica Announces U.S. IND Approval for Novel Ocular Product in Stargardt Disease
Oxford BioMedica plc announced that the U.S. Food and Drug Administration has approved its Investigational New Drug (IND) application for the Phase I/IIa clinical development of StarGen™, a novel gene-based treatment for Stargardt disease. [Oxford BioMedica plc Press Release]

National Cord Blood Program Files Biologics License Application with FDA
The National Cord Blood Program at New York Blood Center’s Howard P. Milstein National Cord Blood Center has submitted the first publicly-announced Biologics License Application for Cord Blood (Hematopoietic Progenitor Cells, Cord) to the Food and Drug Administration. [New York Blood Center Press Release]

Genesis Biopharma Announces Plans to Develop Active Immunotherapy Platform
Genesis Biopharma, Inc., a biotechnology company developing targeted cancer therapies, announced it is expanding its therapeutic strategy to include active immunotherapies to treat various cancers. [Genesis Biopharma, Inc. Press Release]

University of Michigan Stem Cell Trial to Enter Crucial Phase
The first clinical trial using stem cells in Lou Gehrig’s disease patients soon will begin testing the safety of the procedure in an area of the spine that eventually could be life-saving. [The Detroit News]

RegeneRx Phase II AMI Trial on Clinical Hold Due to GMP Compliance Issues at Contract Manufacturer
RegeneRx Biopharmaceuticals, Inc. announced that it has received a notice from the U.S. Food and Drug Administration (FDA) indicating that, due to non-compliance with FDA’s current Good Manufacturing Practice (GMP) regulations by its contract manufacturer, the Company’s Phase II clinical trial of RGN-352, its injectable formulation of Thymosin beta 4 for the treatment of acute myocardial infarction (AMI), has been placed on clinical hold. [RegeneRx Biopharmaceuticals, Inc. Press Release]

bluebird bio Appoints World Leading Experts to Inaugural Scientific Advisory Board
bluebird bio, an emerging leader in the development of innovative gene therapies for severe genetic disorders, announced the appointment of leading experts to its newly formed scientific advisory board. [bluebird bio Press Release]

Seattle BioMed Announces Major Scientific Expansion, New Addition to Leadership
In a bold plan for scientific expansion and leadership for the future, Seattle Biomedical Research Institute (Seattle BioMed) announced that it will integrate a systems biology approach with its global infectious disease research. [Seattle Biomedical Research Institute Press Release]

Start-Up ImmusanT Seeks to Restore Tolerance to Gluten in Celiac Disease with Immunotherapy
Biotechnology company ImmusanT, Inc. announced it has established its operations in Cambridge, Massachusetts and is advancing its strategy to develop an immunotherapeutic vaccine, companion diagnostic and monitoring tool for celiac disease. [PR Newswire]

Laboratory for Malignancy Control Research
Kyoto University and Dainippon Sumitomo Pharma Co., Ltd. announced the launch of a new cooperative project aiming at discovering innovative drugs, diagnostic tools, and therapeutic strategies for life-threatening cancers. [TherapeuticsDaily]

Leaders in Stem Cell Research and Discovery to Share America’s Most Distinguished Prize in Medicine
Three scientists whose pioneering work in isolating human stem cells holds great promise for the future of medicine have been named the recipients of the 11th annual Albany Medical Center Prize in Medicine and Biomedical Research. [PR Newswire]

NIH

NIH Scientists Warming to New Translational Center
Despite concerns previously expressed by many extramural scientists, National Institutes of Health (NIH) campus researchers who showed up yesterday to hear Director Francis Collins unveil a proposed new center devoted to translational research appeared to like the idea. [National Institutes of Health, United States]

Nanoscience and Nanotechnology in Biology and Medicine (R01) (PA-11-148)

Nanoscience and Nanotechnology in Biology and Medicine (R21) (PA-11-149)

Strategic Partnering to Evaluate Cancer Signatures [SPECS II] (U01) (PAR-11-151)

Blood Products Advisory Committee; Notice of Meeting (FR Doc. 2011-6085)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-6304)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-6285)

National Cancer Institute; Notice of Closed Meetings (FR Doc. 2011-6259)

National Cancer Institute; Notice of Closed Meeting (FR Doc. 2011-6258)

CBER

2011 Biological License Application Approvals

2011 Biological License Application Supplement Noteworthy Approvals

2011 Biological Device Application Approvals

March 18, 2011 Approval Letter – RotaTeq

March 17, 2011 Approval Letter – Boostix

April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Public Roster

7342.002 – Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors

April 28-29, 2011: Blood Products Advisory Committee Meeting Announcement

Risk Mitigation Strategies to Address Potential Procoagulant Activity in Immune Globulin Products

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

May 12, 2011: Allergenic Products Advisory Committee Meeting Announcement

Approval History, Letters, Reviews, and Related Documents – Corifact

SOPP 8408.1: Development of Testing Plans and Release of Lots as Part of the Approval Process

REGULATORY

FOOD AND DRUG ADMINISTRATION (United States)

FDA, EMA Announce Pilot for Parallel Assessment of Quality by Design Applications
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design, of new drug marketing applications that are submitted to both agencies.

Risk Mitigation Strategies to Address Potential Procoagulant Activity in Immune Globulin Intravenous Products; Public Workshop [Docket No. FDA-2011-N-0002]

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics [Docket No.FDA-2011-N-0085]

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment [Docket No. FDA-2010-N-0541]

EUROPEAN MEDICINES AGENCY (European Union)

European Medicines Agency Announces Start of Process Improvement of Core Business Procedures
The European Medicines Agency has launched a project to improve processes of its core business, as announced in its ‘Road map to 2015’ in January 2011.

Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 March 2011

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Australian Public Assessment Report (AusPAR) for Prescription Medicines (Updated)

Call for Input: Review to Improve Transparency of the Therapeutic Goods Administration (TGA)

EVENTS

NEW American Society of Gene and Cell Therapy 2011 Translational Science Training Course
May 17, 2011
Seattle, Washington

NEW NIH Gene Therapy Symposium
September 26-27, 2011
Bethesda, United States

NEW 6th Annual New York Stem Cell Foundation Conference
October 11-12, 2011
New York, United States

NEW Stem Cells: A Pathway Through the Maze
December 7-9, 2011
Oxford, United Kingdom

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)

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

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 Position (Johns Hopkins University School of Medicine)

Manager Clinical Affairs (Bioheart, Inc.)

Quality Assurance Specialist – Gene Transfer & Somatic Cell Engineering Facility (Memorial Sloan-Kettering Cancer Center)

Postdoctoral Position – Germline Stem Cells (R. L. Brinster, School of Veterinary Medicine, University of Pennsylvania)

Scientific Director (Adipose Derived Stem Cell Bank)

Process Technical Development Scientist (StemCells, Inc.)

Field Applications Specialist – Cell Therapy (Medical) (Pall Corporation)
 
Postdoctoral Positions – Stem Cell Biology (Joslin Diabetes Center/Harvard Stem Cell Institute)
 
Cell Therapy Manufacturing Manager (Opexa Therapeutics)

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

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