Volume 12.02 | Jan 17

Cell Therapy News 12.02, January 17, 2011.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  

TOP STORY  


Researchers Inch Closer to Unlocking Potential of Synthetic Blood 
A team of scientists has created particles that closely mirror some of the key properties of red blood cells, potentially helping pave the way for the development of synthetic blood. [Press release from the University of North Carolina Lineberger Cancer Center discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

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SCIENCE NEWS


Patient-Derived Stem Cells Could Help Test Cardiac Disease Treatments
Scientists turned skin cells into induced pluripotent stem cells, then coaxed these stem cells to become cardiac cells. The newborn heart cells showed an abnormal electrical activity in the laboratory, recapitulating clinical presentation of the long QT syndrome patient, making them useful for studying this potentially lethal disorder. [Press release from the American Technion Society discussing online prepublication in Nature]
 
Scientists Uncover Inherent Properties of Cell Signaling Pathways
Using an innovative approach based on synthetic biology and mathematical modeling, researchers have explored the workings of a crucial cell-signaling pathway, the mitogen-activated protein kinase cascade. [Press release from the University of Pennsylvania discussing online prepublication in Cell]

Overexpression of Repetitive DNA Sequences Discovered in Common Tumor Cells
Researchers have discovered a previously unknown feature of common tumor cells — massive overexpression of certain DNA sequences that do not code for proteins. These DNA sequences — called satellite repeats — have been studied for their role in chromosomal structure but previously were not suspected of having a role in cancer. [Press release from Massachusetts General Hospital discussing online prepublication in Science]

Scientists Find the “Master Switch” for Key Immune Cells in Inflammatory Diseases
Scientists have identified a protein that acts as a “master switch” in certain white blood cells, determining whether they promote or inhibit inflammation. [Press release from Imperial College London discussing online prepublication in Nature Immunology]

Researchers Gain Better Understanding of Interaction of Human Immune System with HIV
Scientists announced discoveries that are relevant to better understanding of the interaction of the human immune system with HIV and which could potentially guide the development of effective immunization protocols. [Press release from the Seattle Biomedical Research Institute discussing online prepublication in PLoS Pathogens]

Embryonic Stem Cells Are a Potentially Unlimited Source of Functional Platelets for Transfusion
Advanced Cell Technology, Inc. reported that its hemangioblast-based technology can be used to generate functional platelets from human embryonic stem cells (hESCs). This research shows that it is feasible to generate functional megakaryocytes and platelets from hESCs on a large scale. [Press release from Stem Cell & Regenerative Medicine International, Inc. discussing online prepublication in Cell Research]

Syndax Announces Publication of Entinostat NSCLC Data
Syndax, a clinical-stage epigenetics oncology company, announced publication of data of entinostat combined with the demethylating agent Vidaza® (azacitidine) showing effect in reducing tumor burden in differentiated tumor cells in animal tumor models of non-small cell lung cancer (NSCLC). [Press release from Syndax Pharmaceuticals, Inc. discussing online prepublication in Cancer Research]

Nanodisk Gene Therapy
A team of scientists demonstrated that the peptide R9, formed by a specific type of amino-acid (arginine), can encapsulate genetic material, assemble itself with other identical molecules to form nanoparticles and enter directly into the cell nucleus to release the material it contains. The nanoparticles have the shape of a disk, with a diameter measuring 20 nanometers and a height of 3 nm. [Press release from EurekAlert! discussing online prepublication in Biomaterials]

Better Way to Treat Deadly Brain Tumors?
Lab studies show that combining drugs that target a variety of developmental cell signaling pathways may do a better job of killing deadly brain tumors than single drugs that target one pathway at a time. [Press release from Johns Hopkins Medicine discussing online prepublication in Clinical Cancer Research]

Blame the “Chaperone”: Researchers Find Mutation in “Chaperone” Proteins That Lead to Major Developmental Abnormalities
A research team has identified a mutation in a gene that is essential for correct protein-processing in cells. Defects in protein folding are associated with a variety of abnormalities and diseases. [Press release from The Jackson Laboratory discussing online prepublication in the Journal of Biological Chemistry]

Researchers Find Critical Link Between Down Syndrome and Alzheimer’s Disease
Researchers have discovered that the genetic mechanism which destroys brain cells is responsible for early development of Alzheimer’s Disease in people with Down Syndrome and for development of Alzheimer’s Disease in general population — providing a potential new target for drugs that could forestall dementia in people with either condition. [Press release from the University of British Columbia discussing online prepublication in the Journal of Biological Chemistry]

Success in Treating End-Stage Liver Disease
Transplanting autologous bone marrow-derived stem cells into 48 patients with end-stage liver disease resulted in therapeutic benefit to a high number of the patients, report researchers. Yet, the mechanism by which the infusion of CD34+ stem cells improves liver function remains elusive. [Press release from EurekAlert! discussing online prepublication in Cell Transplantation]

Scientists Construct Synthetic Proteins That Sustain Life
In a groundbreaking achievement that could help scientists “build” new biological systems, scientists have constructed for the first time artificial proteins that enable the growth of living cells. [Press release from Princeton University discussing online prepublication in PLoS One]

Biomedical Breakthrough: Discovery Addresses Key Roadblock to Growing Replacement Tissues, Organs
Researchers from Baylor College of Medicine and Rice University have broken one of the major roadblocks on the path to growing transplantable tissue in the lab: they've found a way to grow the blood vessels and capillaries needed to keep tissues alive. [Press release from Baylor College of Medicine discussing online prepublication in Acta Biomaterialia

Inovio Pharmaceuticals' Novel DNA Vaccine for Clade C HIV Achieves Immune Responses and Protection in Non-Human Primates
Inovio Pharmaceuticals, Inc. announced the publication of a scientific paper highlighting positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C viruses. [Press release from Inovio Pharmaceuticals, Inc. discussing online prepublication in Vaccine]

RevaTen Platelet-Rich Plasma Shows Promise as Potential Treatment for Heart Attacks
Researchers at the Stanford University School of Medicine, in collaboration with BioParadox, Inc., have published data supporting the use of platelet-rich plasma as a promising biologic treatment for myocardial infarction. [Press release from EurekAlert! discussing online prepublication in Cardiovascular Revascularization Medicine]
 
Scientists Bring New Hopes to Translate Human Stem Cell Technologies to the Clinic
Scientists have successfully generated new human induced pluripotent stem cells (hiPSCs) that are free from animal products. [University of Hong Kong Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Modeling the Long QT Syndrome with Induced Pluripotent Stem Cells
Researchers report the development of a patient/disease-specific human induced pluripotent stem cell (iPSC) line from a patient with type-2 long QT syndrome (which is due to the A614V missense mutation in the KCNH2 gene). The generated iPSCs were coaxed to differentiate into the cardiac lineage. [Nature]

Tunable Signal Processing in Synthetic MAP Kinase Cascades
This work demonstrates that tunable signal processing is inherent to minimal MAPK modules and elucidates principles for rational design of synthetic signaling systems. [Cell]

Aberrant Overexpression of Satellite Repeats in Pancreatic and Other Epithelial Cancers
The overexpression of satellite transcripts in cancer may reflect global alterations in heterochromatin silencing and could potentially be useful as a biomarker for cancer detection. [Science]
 
IRF5 Promotes Inflammatory Macrophage Polarization and TH1-TH17 Responses
Researchers show that IRF5 expression in macrophages was reversibly induced by inflammatory stimuli and contributed to the plasticity of macrophage polarization. [Nat Immunol]
 
Using Mechanobiological Mimicry of Red Blood Cells to Extend Circulation Times of Hydrogel Microparticles
Researchers synthesized hydrogel microparticles with tunable elasticity in the physiological range, which resemble red blood cells in size and shape, and tested their behavior in vivo. [Proc Natl Acad Sci U S A]
 
Platelets Generated from Human Embryonic Stem Cells Are Functional In Vitro and in the Microcirculation of Living Mice
Researchers report that it is feasible to generate functional megakaryocytes and platelets from human embryonic stem cells on a large scale. [Cell Res]

Combination Therapy with Vidaza and Entinostat Suppresses Tumor Growth and Reprograms the Epigenome in an Orthotopic Lung Cancer Model
Findings show the promise for epigenetic therapy in cancer management and provide an orthotopic lung cancer model that can assess therapeutic efficacy and reprogramming of the epigenome in tumors harboring different genetic and epigenetic profiles to guide use of these drugs. [Cancer Res]

Internalization and Kinetics of Nuclear Migration of Protein-Only, Arginine-Rich Nanoparticles
Researchers have investigated the uptake and kinetics of intracellular migration of protein nanoparticles built up by a chimerical multifunctional protein, and functionalized by a pleiotropic, membrane-active terminal peptide. [Biomaterials]

Autologous Hematopoietic Stem Cell Transplantation in 48 Patients with End-Stage Chronic Liver Diseases
Results suggest that autologous CD34+ stem cell transplantation may be safely administered and appears to offer some therapeutic benefit to patients with both viral and autoimmune-induced end-stage liver disease. [Cell Transplant]

De Novo Designed Proteins from a Library of Artificial Sequences Function in Escherichia Coli and Enable Cell Growth
A central challenge of synthetic biology is to enable the growth of living systems using parts that are not derived from nature, but designed and synthesized in the laboratory. As an initial step toward achieving this goal, researchers probed the ability of a collection of >106 de novo designed proteins to provide biological functions necessary to sustain cell growth [PLoS One]

Covalently Immobilized Platelet-Derived Growth Factor-BB Promotes Angiogenesis in Biomimetic Poly(Ethylene Glycol) Hydrogels
In this work bioactive, covalently immobilized platelet-derived growth factor BB was shown to induce tubulogenesis on two-dimensional modified surfaces, migration in three-dimensional degradable hydrogels and angiogenesis in a mouse cornea micropocket angiogenesis assay. [Acta Biomater]

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POLICY


Data Exclusivity for Biologics
As part of the recently enacted health-care reform legislation in the United States, the U.S. Congress authorized an abbreviated regulatory pathway for the approval of biosimilars (also often described as follow-on biologics). [Congress, United States]
 
Maryland Stem Cell Research Commission Receives Record Number of Applications for Funding
The Maryland Stem Cell Research Commission has received 180 applications to the Maryland Stem Cell Research Fund in response to its three 2011 Requests for Applications. [Maryland Stem Cell Research Commission, United States]

A New Pathway for the Regulation and Governance of Health Research
The Academy's review, 'A new pathway for the regulation and governance of health research' was published. The report proposes four key principles that should underpin the regulation and governance framework around health research in the UK and makes recommendations. [The Academy of Medical Sciences, United Kingdom]

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BUSINESS


Sanofi-aventis Enters into Two Research & Development Collaborations with the University of California, San Francisco
Sanofi-aventis and the University of California, San Francisco announced that they have formed two research and development collaborations that join together leaders from academia and industry to more rapidly advance groundbreaking innovation from the lab to the patient. [Sanofi-aventis Press Release]

Merck and PAREXEL Form Strategic Alliance Focused on Clinical Development of Biosimilar Candidates
Merck and PAREXEL International Corporation announced that they have entered into an alliance by which PAREXEL will provide strategic access to global clinical development services for designated biosimilar candidates to Merck BioVentures. [Merck & Co., Inc. Press Release]

European Commission Clears Acquisition of Genzyme Corporation by sanofi-aventis
Sanofi-aventis announced that the European Commission has cleared sanofi-aventis' proposed acquisition of Genzyme Corporation unconditionally under EU merger control rules. [Sanofi-aventis Press Release]

A United and Powerful Initiative Launched to Strengthen the UK Economy
LifeSciencesUK, a new initiative representing the human healthcare industry, has been launched by the UK's four key healthcare trade associations to build on the government's commitment to transform the life sciences environment in the UK. [LifeSciencesUK Press Release]

Cancer Research UK and AstraZeneca Collaborate to Trial Combinations of New Cancer Drugs
Cancer Research UK’s drug development office has signed a Strategic Combinations Alliance with AstraZeneca to take combinations of experimental cancer drugs into early phase clinical trials. [Cancer Research UK Press Release]

VistaGen Therapeutics and NuPotential Receive NIH Grant to Develop Safer Approaches for Producing Patient-Specific Induced Pluripotent Stem Cells
VistaGen Therapeutics, Inc. and NuPotential, Inc. announced that the National Heart, Lung and Blood Institute of the U.S. National Institutes of Health (NIH) has awarded to the companies a grant of approximately $500,000 to accelerate development of novel and safer approaches to generate patient-specific induced pluripotent stem cells for regenerative medicine, drug discovery and drug rescue. [Business Wire]

UF Researchers Receive $4.7 Million to Study Improved Therapies for Hemophilia
University of Florida (UF) researchers have received four grants totaling almost $4.7 million to develop therapies for improving the health and quality of life of people with hemophilia. [University of Florida Press Release]

Exiqon Releases Second Generation Human and Mouse MicroRNA Inhibitor Libraries
Exiqon A/S announced the launch of the second generation of miRCURY LNA™ microRNA Inhibitor libraries for genome-wide screening of microRNA function in human and mouse. [Exiqon A/S Press Release]

OncoMed Pharmaceuticals Initiates Phase I Clinical Trial of Anti-Cancer Stem Cell Therapeutic OMP-59R5
OncoMed Pharmaceuticals, Inc., a company developing novel therapeutics that target cancer stem cells, announced that patient dosing has commenced in a Phase I clinical trial of OMP-59R5 in patients with advanced solid tumor cancers. [OncoMed Pharmaceuticals, Inc. Press Release]

Independent Data Safety Monitoring Board Gives “Go-Ahead” to Complete Dosing in First Leg of Advaxis’ Phase II Cervical Dysplasia Trial
The science team from Advaxis, Inc. met with the Data Safety Monitoring Board, an independent group of medical experts, yesterday and received approval to dose all remaining patients in the initial forty patient leg of the 120-patient, cervical dysplasia clinical trial being conducted in the United States. [Business Wire]

Health Canada Requests Additional Information to Support Application for Approval of Prochymal 
Osiris Therapeutics, Inc. announced that Health Canada has requested additional information in support of the Company’s application for approval of Prochymal, a stem cell therapy, for the treatment of graft versus host disease. [Osiris Therapeutics, Inc. Press Release]

Cancer Research UK and Cancer Research Technology Establish Team of Stem Cell Experts to Beat Cancer
Cancer Research UK and its commercial arm, Cancer Research Technology, have established a team of scientists with expertise in cancer stem cell research to identify new targets to detect, monitor and treat cancer. The charity has hand-picked four world class research groups to collaborate on an initial two-year research project to unravel the role of cancer stem cells in the development, growth and spread of tumors in breast, prostate and head and neck cancers. [Cancer Research UK Press Release]

Biotech Firms Fight Generics
Brand-name drug companies are fighting to weaken a provision of the health overhaul that was designed to open up generic competition in biotechnology medicines and save billions of dollars. [The Wall Street Journal]

NAE Announces Winners of the Draper, Russ, and Gordon Prizes
The engineering profession's highest honors for 2011, presented by the National Academy of Engineering (NAE), recognize three achievements that led to developments in guiding cell evolution, sequencing the human genome, and better preparing students for the engineering work force. [National Academy of Engineering Press Release]

Scientist Wins Award for Tackling Devastating Brain Disease in Kids
Miguel Sena-Esteves, PhD, associate professor of neurology, was presented with the annual “See the Light” award from the Mathew Forbes Romer Foundation (MFRF) in recognition of his leadership in the fight against children’s genetic diseases of the brain. Dr. Sena-Esteves is investigating the potential of using gene therapy techniques to replace the faulty gene that causes Tay-Sachs disease. [University of Massachusetts Press Release]


NIH
 

Cancer Costs Projected to Reach at Least $158 Billion in 2020
Based on growth and aging of the U.S. population, medical expenditures for cancer in the year 2020 are projected to reach at least $158 billion (in 2010 dollars) — an increase of 27 percent over 2010, according to a National Institutes of Health analysis.

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-385)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-629)
 
Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-871)
 
Meeting of the National Vaccine Advisory Committee (FR Doc. 2011-868)

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CBER


Fast Track Designation Request Performance 
The Food and Drug Administration Modernization Act of 1997 includes Section 112, “Expediting study and approval of fast track drugs.” This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Complete List of Substantially Equivalent 510(k) Device Applications

Complete List of Currently Approved NDA and ANDA Application Submissions

Complete List of Currently Approved Premarket Approvals (PMAs)

Complete List of Licensed Products and Establishments 

7342.001 – Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors


REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

U.S. FDA's Medtech Forecast to Prepare CDRH for Complex Submissions
The U.S. Food and Drug Administration (FDA) has issued a ten-year forecast for the medtech sector, identifying emerging medical device technologies and types of devices that manufacturers are highly likely to submit to the agency's Center for Devices and Radiological Health for pre-market decision making.
 
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice Quality System Regulation [FR Doc. 2011-455] 

EUROPEAN MEDICINES AGENCY (European Union)

European Medicines Agency Opens Public Discussion on Need for Active Control in Clinical Trials
The European Medicines Agency has published a reflection paper on the need for active control in therapeutic areas where use of a placebo is deemed ethical and one or more established medicines are available.

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Drug Safety Update: January 2011

Information Sent to Healthcare Professionals in December About the Safety of Medicines
 
THERAPEUTIC GOODS ADMINISTRATION (Australia)

Streamlined Submission Process Documents
To support sponsors in meeting the regulatory requirements under the streamlined submission process, a regulatory framework of legislative instruments has been created.

National Coordinating Committee on Therapeutic Goods (Updated Membership Details)

Australian Public Assessment Report (AusPAR) for Prescription Medicines (Filgrastim, Nitisinone)

Advisory Committee on the Safety of Medicines (Updated Meeting Dates)


EVENTS 

NEW Personalized Medicine World Conference (PMWC) 2011
January 18-19, 2011
Silicon Valley, United States

NEW Biomanufacturing Summit 2011
January 24-25, 2011
San Diego, United States

NEW Therapeutic Approaches to Neurodegeneration-Age Modifiers, Proteostasis, and Stem Cells
February 14-17, 2011
Nassau, Bahamas

NEW EuTRACC Transcription Networks Symposium
March 21-23, 2011
Berlin, Germany

NEW 2011 Translational Regenerative Medicine Forum
April 6-8, 2011
Washington, DC, United States

NEW 6th Annual Wisconsin Stem Cell Symposium: Reprogramming and Controlling Stem Cell Phenotype
April 27, 2011
Madison, United States

NEW Israeli Stem Cells Society 4th Annual Meeting 2011
May 23-24, 2011
Tel-Hashomer, Israel 
 
NEW China Vaccine Summit 2011
May 25-27, 2011
Beijing, China

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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