Volume 11.23 | Jun 21

Cell Therapy News 11.23, June 21, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  |  Unsubscribe


Clinical Trial of Gene Therapy for AIDS-Related Lymphoma Shows Promising Results Against Cancer and HIV Infection
Patients underwent autologous hematopoietic cell transplantation in which their own blood stem cells were harvested and genetically engineered with three anti-HIV ribonucleic acids that block HIV from infecting new cells. [Press release from City of Hope National Medical Center discussing online prepublication in Science Translational Medicine]



Defects in Immune System Enzyme May Increase Risk of Autoimmune Disorders
A multi-institutional research team has found that rare variants in the gene coding an enzyme that controls the activity of a key immune cell occur more frequently in individuals with autoimmune disorders like rheumatoid arthritis and type 1 diabetes. [Press release from Massachusetts General Hospital Center for Regenerative Medicine discussing online prepublication in Nature]

Gamma Interferon Prompts Stem Cell Response to Fight Infection
Findings show that gamma interferon not only activates stem cells during infection, but also regulates stem cells in normal times, enabling them to maintain the types of blood cells that exist in proportion or homeostasis. [Press release from the Baylor College of Medicine discussing online prepublication in Nature]

Scientists Identify Three New Genetic Variants That Increase Testicular Cancer Risk
A study led by the Institute of Cancer Research has identified three new genetic risk factors for testicular cancer, taking the number of genomic regions known to be associated with testicular cancer risk to six. [Press release from the Wellcome Trust discussing online prepublication in Nature Genetics]

Adding Nucleic Acid Testing to HIV Screening May Help Identify More People with HIV
Researchers showed that nucleic acid testing increased the HIV detection yield by 23%. [Press release from the University of California, San Diego discussing online prepublication in the Annals of Internal Medicine]

Stem Cell Breakthrough Offers New Hope for Lung Disease Patients
For the first time researchers have found a type of stem cell that could prove crucial in reducing injury and scarring in the lung and even generate new lung cells. [Press release from The University of Western Australia discussing online prepublication in the American Journal of Respiratory and Critical Care Medicine]

Scientists Determine Structure of Immune Molecule that Counteracts Many Strains of HIV
In findings that contribute to efforts to design an AIDS vaccine, scientists have determined the structure of an immune system antibody molecule that effectively acts against most strains of human immunodeficiency virus. [Press release from The Scripps Research Institute discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

Researchers Identify Key Enzyme in Melanoma Cell Development
Researchers have discovered a mechanism by which an enzyme regulates gene expression and growth in melanoma cells, a finding that could someday lead to more effective drugs to attack cancers and make them more treatable. [Press release from Virginia Commonwealth University discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

Stem Cell Therapy 'Damage' Seen in Kidney Disease Case
A new complication has been seen in a patient with kidney disease who received stem cell therapy, scientists have warned. [Press release from BBC News discussing online prepublication in the Journal of the American Society of Nephrology]

Combined BRAF-Targeted and Immunotherapy Shows Promise for Melanoma Treatment
Combined targeted therapy against the BRAF/MAPK pathway with immunotherapy shows promise as a new therapeutic approach for the treatment of melanoma, according to results of a preclinical study. [Press release from Massachusetts General Hospital discussing online prepublication in Cancer Research]

NexBio® and Weill Cornell Medical College Publish Preclinical Study Showing DAS181 (Fludase®) Anti-Influenza Drug Inhibits Parainfluenza Virus
NexBio, Inc. announced the publication of a “Major Article” in the Journal of Infectious Diseases of a preclinical study showing that treatment with DAS181 (Fludase®) inhibits infection with multiple human parainfluenza virus strains. [Press release from NexBio, Inc. discussing online prepublication in the Journal of Infectious Diseases]

Specific Blood-Derived Cells Promote Survival in Heart Attack Model
A research team from McGill University report a beneficial effect on cardiac function in mouse models when implanted monocytes helped preserve cardiac function following a heart attack. [Press release from EurekAlert! discussing online prepublication in Cell Transplantation]

Scientific American Article Says DNA Vaccines Are Reaching Their Potential
The article details the “rebirth” of DNA vaccines, which are recognized as safer; easier and faster to develop and manufacture; and, not requiring refrigeration — in contrast to traditional vaccines. [Press release from Inovio Pharmaceuticals, Inc. discussing online prepublication in Scientific American]

Tengion Presents New Data Supporting Its Organ Regeneration Platform™
The data demonstrate that smooth muscle cells sourced from adipose tissue, which have been demonstrated to promote regeneration of tubular tissues and hollow organs, have protein and gene expression profiles distinct from those generated by mesenchymal stem cells. [Press release from Tengion, Inc. discussing research presented at the 8th Annual Meeting of the International Society for Stem Cell Research]

Human Embryonic-Like Extracellular Matrix Significantly Inhibits Tumor Growth and Cancer Cell Proliferation
Studies of the human extracellular matrix produced under proprietary conditions of hypoxia and suspension have demonstrated its ability to diminish or eliminate tumor load in melanoma, breast cancer, colon cancer and glioma, both in vitro and in vivo. [Press release from Histogen, Inc. discussing research presented at the 8th Annual Meeting of the International Society for Stem Cell Research]

Stem Cells From Own Eyes Restore Vision to Blind
Patients blinded in one or both eyes by chemical burns regained their vision after healthy stem cells were extracted from their eyes and reimplanted, according to a report by Italian researchers. [Press release from Bloomberg Businessweek discussing research presented at the 8th Annual Meeting of the International Society for Stem Cell Research]

New Injectable Bone Material Invented for Use in Stem Cell Delivery
A team of researchers at the University of Nottingham have invented a new class of materials that can be injected by surgeons as a low-viscosity fluid into the body that, using body heat as the only trigger, converts into a tough porous material with mechanical properties that mimic human cancellous bone. [Press release from PR Newswire discussing research to be presented at the 37th Annual Meeting & Exposition of the Controlled Release Society]

New Data Presented from EMBLEM™ Study for Pipeline Drug Epratuzumab for Patients Suffering from Moderate to Severe Systemic Lupus Erythematosus
UCB and Immunomedics, Inc. announced new lupus drug candidate, epratuzumab, provided a significant reduction in disease activity in patients with moderate to severe active systemic lupus erythematosus. [Press release from Immunomedics, Inc. discussing research presented at the European League Against Rheumatism Annual Meeting]

Gene Therapy Reverses Type 1 Diabetes in Mice
Using gene therapy, the team from Baylor College of Medicine in Houston tried to counter the two defects that cause type 1 diabetes: autoimmune attack and destruction of the insulin-producing beta cells. [Press release from Newswise discussing research presented at The Endocrine Society’s 92nd Annual Meeting]

Oxford BioMedica Announces Two-Year Phase I/II Results of ProSavin® In Parkinson's Disease
Oxford BioMedica announced new data from the ongoing Phase I/II trial of ProSavin®, its novel gene therapy for the treatment of Parkinson’s disease. [Oxford BioMedica Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Functionally Defective Germline Variants of Sialic Acid Acetylesterase (SIAE) in Autoimmunity
Functionally defective SIAE rare and polymorphic variants represent a strong genetic link to susceptibility in relatively common human autoimmune disorders. [Nature]

Quiescent Hematopoietic Stem Cells Are Activated by IFN-Gamma in Response to Chronic Infection
Findings implicate interferon-gamma (IFN-gamma) both as a regulator of hematopoietic stem cells during homeostasis and under conditions of infectious stress. [Nature]

Variants Near DMRT1, TERT and ATF7IP Are Associated with Testicular Germ Cell Cancer
Researchers identified three new susceptibility loci for testicular germ cell tumor, two of which include genes that are involved in telomere regulation. [Nat Genet]

Human Amnion Epithelial Cell Transplantation Abrogates Lung Fibrosis and Augments Repair
Human amnion epithelial cells offer promise as a cellular therapy for alveolar restitution and reducing lung inflammation and fibrosis. [Am J Respir Crit Care Med]

Notch 1 as a Potential Therapeutic Target in Cutaneous T Cell Lymphoma
By immunohistochemistry of 40 biopsies taken from skin lesions of mycosis fungoides and Sezary syndrome researchers demonstrated prominent expression of Notch1 on tumor cells, especially in the more advanced stages. [Blood]

Structure and Function of Broadly Reactive Antibody PG16 Reveal an H3 Subdomain that Mediates Potent Neutralization of HIV-1
Monoclonal antibodies PG9 and PG16 use unique structural features to mediate potent neutralization of HIV-1 that may be of utility in antibody engineering and for high-affinity recognition of a variety of therapeutic targets. [Proc Natl Acad Sci U S A]

Human Polynucleotide Phosphorylase Selectively and Preferentially Degrades MicroRNA-221 in Human Melanoma Cells
Targeted overexpression of hPNPaseold-35 might provide an effective therapeutic strategy for microRNA-221–overexpressing and IFN-resistant tumors, such as melanoma. [Proc Natl Acad Sci U S A]

Bmi1 Distinguishes Immature Retinal Progenitor/Stem Cells from the Main Progenitor Cell Population and is Required for Normal Retinal Development
Bmi1 distinguishes immature retinal progenitor cells (RPCs) from the main RPC population and is required for normal retinal development. [Stem Cells]

Angiomyeloproliferative Lesions Following Autologous Stem Cell Therapy
This case illustrates that the development of angiomyeloproliferative lesions is a possible complication of stem cell therapy. [J Am Soc Nephrol]

RNA-Based Gene Therapy for HIV with Lentiviral Vector–Modified CD34+ Cells in Patients Undergoing Transplantation for AIDS-Related Lymphoma
Researchers have demonstrated stable vector expression in human blood cells after transplantation of autologous gene-modified hematopoietic progenitor cells. [Sci Transl Med]

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The Path to Personalized Medicine
The leaders of the National Institutes of Health and the Food and Drug Administration have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth. Together, they have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the right time. [Food and Drug Administration and the National Institutes of Health, United States]

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STEMCELL Technologies is Proud to Announce STEMcircles™, a Virus-Free Technology for Reprogramming Cells
STEMCELL Technologies, Inc. announced that they have signed a licensing agreement with Stanford University for a virus-free technique used for the generation of induced pluripotent stem cells. [STEMCELL Technologies, Inc. Press Release]

OncoMed Pharmaceuticals and Bayer Schering Pharma Announce Strategic Alliance to Develop Anti-Cancer Stem Cell Therapeutics
OncoMed Pharmaceuticals, Inc. and Bayer Schering Pharma AG, Germany, announced a global strategic alliance to discover, develop and commercialize novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway. [OncoMed Pharmaceuticals, Inc. Press Release]

Wisconsin Governor Jim Doyle and California’s State Stem Cell Agency Sign Declaration Of Cooperation to Advance Stem Cell Research Toward Cures
Wisconsin Governor Jim Doyle and the Chair of the Governing Board of the California state stem cell agency, Robert Klein, signed a Declaration of Cooperation that aims to create a framework for joint funding between researchers in the two states and to accelerate the pace of development of cellular therapies to reach patients. [California Institute For Regenerative Medicine Press Release]

Promega and Cellular Dynamics Partner to Validate Stem Cell-Based In Vitro Assays for Predicting Drug-Induced Cardiotoxicity
Cellular Dynamics International and Promega have entered into a research collaboration with the goal of bringing more relevant and highly predictive toxicity testing to the drug discovery process. [Cellular Dynamics International Press Release]

Gladstone and Institute for Systems Biology Collaborate to Discover New Genes Associated with the Onset of Huntington's Disease
The Institute for Systems Biology is collaborating with the Gladstone Institute of Neurological Disease and its Taube-Koret Center for Huntington's Disease Research to use whole-genome sequencing to identify genes and novel drug targets related to the onset and progression of Huntington's disease. [The Institute for Systems Biology Press Release]

BioTime Forms New Subsidiary, OrthoCyte Corporation, to Develop Treatments for Orthopedic Conditions Using Stem Cell Technology
BioTime, Inc. announced that it has organized a new subsidiary, OrthoCyte Corporation, for the purpose of developing novel therapeutics based on stem cell technology for the treatment of injuries and disorders affecting the musculoskeletal system, including therapeutics that would regenerate bone, cartilage, tendons and ligaments. [BioTime, Inc. Press Release]

University of California, San Diego, Salk Institute for Biological Studies and Life Technologies Team to Conduct Cell Transplant Research for ALS
The University of California, San Diego, The Salk Institute for Biological Studies and Life Technologies Corporation announced the initiation of studies which may lead to the future development of cell transplant therapy for amyotrophic lateral sclerosis (ALS). [Life Technologies Corporation Press Release]

Genzyme’s Alemtuzumab for Treatment of Multiple Sclerosis Granted Fast Track Status by FDA
Genzyme Corporation announced that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). [Genzyme Corporation Press Release]

CureVac Starts Phase IIa with mRNA Immunotherapeutic in Non-Small Cell Lung Cancer
CureVac GmbH announced that the Paul-Ehrlich-Institute, the German regulatory authority for medicinal products, has approved the start of a Phase IIa trial for CV9201 to treat Non-Small Cell Lung Cancer. [CureVac GmbH Press Release]

Pluripotent Stem Cell Leader Shinya Yamanaka to Receive Inamori Foundation's 26th Annual Kyoto Prize in Advanced Technology
The non-profit Inamori Foundation announced that Dr. Shinya Yamanaka will receive its 26th annual Kyoto Prize in Advanced Technology, which for 2010 focuses on the fields of Biotechnology and Medical Technology. Dr. Yamanaka will receive the award for his pioneering work in developing a technology to generate pluripotent stem cells that does not require the use of human embryos. [Inamori Foundation Press Release]

Nice University Hospital Center: Inauguration of the Cellular and Gene Therapy Unit
The cellular and gene therapy unit, a project initiated in 1998, will offer patients access to new approaches to cellular and gene therapies. [Team Côte d'Azur Press Release]

SanBio Receives FDA Clearance to Initiate Cell Therapy Clinical Studies for Stroke Recovery
SanBio Inc. announced that the United States Food and Drug Administration (FDA) has approved the clinical testing of their SB623 regenerative medicine product in patients suffering from disability caused by cerebral stroke. [PR Newswire]

Companies Pledge to Make More Trial Data Public
An international organization of pharmaceutical companies has adopted new guidelines governing the publication of clinical trial results. The policy calls for the industry to publish the results of late-stage, 'phase III' clinical trials in peer-reviewed journals, regardless of the trials' outcome. [NatureNews]


Diseased Cells Fail to Win Approval
In the latest obstacle to expanding the number of embryonic stem-cell lines eligible for U.S. federal funding, a National Institutes of Health committee has unanimously rejected dozens of cell lines carrying mutations for specific diseases.

New Videos Reveal How NIH Identifies the Most Promising Research Applications
The National Institutes of Health's Center for Scientific Review released a new video to show new applicants and others how NIH assesses over 80,000 grant applications each year to help find those with the most merit.

NIH and Wellcome Trust Announce Partnership to Support Genomic, Population-Based Studies in Africa
The National Institutes of Health (NIH) and the Wellcome Trust announced a partnership with African researchers to conduct genetic and environmental studies in Africa of common, non-communicable disorders, such as heart disease and cancer, as well as communicable diseases, such as malaria.

Request for Information: Updating the Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorder Research (NOT-MH-10-025)

Notice of Intent to Publish a Funding Opportunity Announcement for the Centers Program for Research on HIV/AIDS and Mental Health (P30) (NOT-MH-10-022)

Amendment: PA-09-119: Phased Innovation Award Program for AIDS Vaccine Research (R21/R33) (NOT-AI-10-034)

Expanding and Personalizing Treatment Options for Alcohol Use Disorders Including Pharmacogenomics (R01) (PAS-10-215)

Increased Budget Limit for Applications Submitted in Response to PAR-09-135, Replication, Fine-Mapping and Sequencing: Follow-Up on Genome-Wide Association Studies for Arthritis and Musculoskeletal and Skin Diseases (R01) (NOT-AR-10-040)

Novel NeuroAIDS Therapeutics: Integrated Preclinical/Clinical Program (P01) (PAR-10-216)



Risk Evaluation and Mitigation Strategy Public Meeting

Currently Approved CBER NDAs/ANDAs



FDA Pushes Orphan Drug Research
The Food and Drug Administration (FDA) published a list of 235 treatments that may have benefit in rare disorders and already have marketing clearance for other uses.

Urgent Medical Device Removal: HIV-1 MONITOR Test, v1.5


Publication of New Enforcement Strategy
A new enforcement strategy has been published by the Inspection, Enforcement and Standards Division.


Drugs Designated as Orphan Drugs

Presentations About the Regulation of Blood and Tissues

Therapeutic Goods Committee (TGC) (Updated)


Accelerating Anticancer Agent Development and Validation
June 23-25, 2010
North Bethesda, United States

3nd International Symposium on Cellular Delivery of Therapeutic Macromolecules
June 26-29, 2010
Cardiff, United Kingdom

XXXIst International Congress of the International Society of Blood Transfusion (ISBT) in joint cooperation with the 43rd Congress of the German Society for Transfusion Medicine and Immunohematology (DGTI)
June 26-July 1, 2010
Berlin, Germany

16th Annual Meeting of the Japan Society of Gene Therapy (JSGT)
July 1-3, 2010
Utsunomiya City, Japan

Worldwide Innovative Networking (WIN) Symposium in Personalized Cancer Medicine
July 7-9, 2010
Paris, France

Translational Cancer Medicine 2010 – USA
July 11-14, 2010
San Francisco, United States

United Kingdom National Stem Cell Network (UKNSCN) Annual Scientific Conference
July 12-14, 2010
Nottingham, United Kingdom

2nd International Conference on Cellular and Molecular Bioengineering (ICCMB2)
August 2-4, 2010
Singapore City, Singapore

CHI's 5th Annual Immunotherapeutics and Vaccine Summit (ImVacS)
August 17-19, 2010
Cambridge, United States

Select Biosciences 3rd Annual Stem Cells Europe Conference
August 24-25, 2010
Edinburgh, Scotland

Select Biosciences 2nd Annual World Biobanking Summit
August 24-25, 2010
Edinburgh, Scotland

Select Biosciences Inaugural Cellular Therapy Summit
August 24-25, 2010
Edinburgh, Scotland

Viral Vectors in Gene Therapy: Applications and Novel Production Methods
August 26-September 4, 2010
Kuopio, Finland

International Society for Cellular Therapy (ISCT) – Europe 2nd Regional Meeting
September 11-14, 2010
Belgirate, Italy

Hydra VI: The European Summer School on Stem Cells & Regenerative Medicine
September 11-17, 2010
Hydra, Greece

Joint Metastasis Research Society – American Association of Cancer Research Conference on Metastasis and the Tumor Microenvironment
September 12-15, 2010
Philadelphia, United States

Stem Cells USA & Regenerative Medicine Congress 2010
September 13-15, 2010
Philadelphia, United States

Select Biosciences 7th Annual RNAi & miRNA Europe
September 14-15, 2010
Dublin, Ireland

Select Biosciences Inaugural Epigenetics Europe Conference
September 14-15, 2010
Dublin, Ireland

Select Biosciences Inaugural Genomics Automation Europe Conference
September 14-15, 2010
Dublin, Ireland

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – Asia Pacific 2010
September 15-17, 2010
Sydney, Australia

International Society for Cell and Gene Therapy of Cancer (ISCGT) Congress
September 27-29, 2010
Doha, Qatar

4th American Association of Cancer Research International Conference on Molecular Diagnostics in Cancer Therapeutic Development
September 27-30, 2010
Denver, United States

Select Biosciences 6th Annual Ion Channel Targets Conference
September 28-29, 2010
Washington, DC, United States

2010 World Stem Cell Summit
October 4-6, 2010
Detroit, United States

5th World Congress on Preventive & Regenerative Medicine (WCRM)
October 5-7, 2010
Hannover, Germany

17th Annual Meeting German Society for Gene Therapy (DG-GT e.V.)
October 6-9, 2010
Munich, Germany

COGEM Symposium: GM Viruses as Medicine: Panacea or Pandora's Box?
October 7, 2010
Amsterdam, The Netherlands

American Association of Blood Banks (AABB) Annual Meeting & Cellular Therapy and Transfusion Medicine Expo (CTTXPO) 2010
October 9-12, 2010
Baltimore, United States

Translational Cancer Research for Basic Scientists
October 17-22, 2010
Boston, United States

European Society of Gene and Cell Therapy (ESGCT) 18th Annual Congress
October 22-25, 2010
Milan, Italy

3rd Annual Dubai Congress on Anti-Aging and Aesthetic Medicine (DCAAAM)
October 26-27, 2010
Dubai, United Arab Emirates

World Stem Cells & Regenerative Medicine Congress Asia 2010
October 26-29, 2010
Singapore City, Singapore

Select Biosciences 3rd Annual Molecular Diagnostics World Congress
October 28-29, 2010
San Diego, United States

Fraunhofer Life Science Symposium 2010
October 29-30, 2010
Leipzig, Germany

Stem Cell Society Singapore Symposium 2010: Translating Science to Therapy
November 2-3, 2010
Singapore City, Singapore

World Cord Blood Congress
November 4-7, 2010
Marseille, France

Select Biosciences 5th Annual European Biomarkers Summit
November 9-10, 2010
Florence, Italy

Select Biosciences International Forum on Stem Cells
November 12-13, 2010
Tianjin, China

Select Biosciences 2nd Annual RNAi Asia Conference
November 15-16, 2010
Singapore City, Singapore

9th Annual Gene Therapy Symposium for Heart, Lung, and Blood Diseases
November 17-19, 2010
Sonoma, United States

Stem Cell Network 10th Annual Scientific Meeting
November 22-24, 2010
Calgary, Canada

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – North America 2010 Annual Conference
December 5-8, 2010
Orlando, United States

Phacilitate 7th Annual Cell & Gene Therapy Forum 2011
January 24-26, 2011
Washington DC, United States

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



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