Volume 11.46 | Nov 29

Cell Therapy News 11.46, November 29, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  


Gene Therapy Prevents Memory Problems in Mice with Alzheimer's Disease 
Humans with Alzheimer's disease and mice genetically engineered to simulate the disease have abnormally low levels of an enzyme called EphB2 in memory centers of the brain. Improving EphB2 levels in such mice by gene therapy completely fixed their memory problems. [Press release from EurekAlert! discussing online prepublication in Nature]



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Scientists Report Partial Reversal of Age-Related Degeneration in Aged Mice
Scientists say they have for the first time partially reversed age-related degeneration in mice, resulting in new growth of the brain and testes, improved fertility, and the return of a lost cognitive function. [Press release from the Dana-Farber Cancer Institute discussing online prepublication in Nature]

Researchers Shine Light on How Some Melanoma Tumors Evade Drug Treatment
Findings pinpoint a critical gene involved in melanoma growth and provide a framework for discovering ways to tackle cancer drug resistance. [Press release from Dana-Farber Cancer Institute discussing online prepublication in Nature]

Rett Syndrome Mobilizes Jumping Genes in the Brain
In patients with Rett syndrome a mutation in the MeCP2 gene mobilizes so-called L1 retrotransposons in brain cells, reshuffling their genomes and possibly contributing to the symptoms of the disease when they find their way into active genes. [Press release from the Salk Institute for Biological Studies discussing online prepublication in Nature]

Guiding Cancer Cells to Their Fate
Researchers created control devices based on RNA, which can be used to synthetically rewire cellular behavior, making the cells more sensitive to a drug that causes cell death. [Press release from EurekAlert! discussing online prepublication in Science]
Researchers First to Turn Normal Skin Cells into Three-Dimensional Cancers in Tissue Culture Dishes
Researchers have successfully transformed normal human tissue into three-dimensional cancers in a tissue culture dish for the first time. [Press release from Stanford University School of Medicine discussing online prepublication in Nature Medicine]
Targeted Therapy Reactivates 'Guardian of the Genome' in Resistant Cancer
A study demonstrating pharmacological rescue of a key tumor suppressor may lead to new therapeutic strategies for human cancer and significantly broaden the types of tumors that respond to targeted therapy, including those that have been resistant to current treatments. [Press release from EurekAlert! discussing online prepublication in Cancer Cell]
New Path Found for Colon Cancer Drug Discovery
An old pinworm medicine is a new lead in the search for compounds that block a signaling pathway implicated in colon cancer. [Press release from Vanderbilt University Medical Center discussing online prepublication in Nature Chemical Biology]
Method for Manufacturing Patient-Specific Human Platelets
Skin cells from humans can be revamped into pro-clotting cells called platelets, according to a study. [Press release from EurekAlert! discussing online prepublication in the Journal of Experimental Medicine]
In the Test Tube, Teams Reconstruct a Cancer Cell’s Beginning
What prompts normal cells to transform themselves into cancerous cells? Researchers have identified factors in the very first step of the process and reconstituted this first step in the test tube. [Press release from the University of Texas Health Science Center San Antonio discussing online prepublication in Nature Structural and Molecular Biology]
Discovery Halts Breast Cancer Stem Cells
Breast cancer stem cells (CSCs) are stimulated by estrogen via a pathway that mirrors normal stem cell development. Disrupting the pathway, researchers were able to halt the expansion of breast CSCs, a finding that suggests a new drug therapy target. [Press release from Tufts University School of Medicine discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

Tiny RNA Molecules Control Labor, May Be Key to Blocking Premature Birth, Researchers Find
Tiny molecules called microRNAs act together with hormones to control the onset of labor, raising the prospect that RNA-based drugs might be able to prevent premature labor, researchers at have discovered. [Press release from UT Southwestern Medical Center discussing online prepublication in the Proceedings of the National Academy of Sciences USA]
Personalized Medicine: Tumor Analysis Reveals New Opportunities for Existing Cancer Drugs
Targeted cancer therapies such as trastuzumab (Herceptin), gefitinib (Iressa) and erlotinib (Tarceva) could be used to treat a wider range of cancers than previously thought, according to new research. [Press release from Compendia Bioscience, Inc. discussing research presented at the 22nd EORTC-NCI-AACR  Symposium on Molecular Targets and Cancer Therapeutics]
Engineers Introduce Thermotherapy as a Chemotherapy Alternative
Using hyperthermia, engineering researchers unveiled a new method to target and destroy cancerous cells. [Press release from Virginia Polytechnic Institute and State University discussing research presented at the 63rd Annual Meeting of the American Physical Society]
Celldex Therapeutics Reports Positive Results from Rindopepimut Phase II Brain Cancer Study
Celldex Therapeutics, Inc. announced the presentation of complete data for the primary endpoint of ACT III, a multi-center, single arm, Phase II clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed glioblastoma multiforme. [Press release from Celldex Therapeutics, Inc. discussing research presented at the Annual Meeting of The Society for Neuro-Oncology 2010]
Cardio3 BioSciences Announces Positive Outcomes of the C-Cure® Phase II Clinical Trial in Heart Failure Patients
The Belgian biotechnology company, Cardio3 BioSciences announced positive six-month results, including significant functional and clinical benefit, from the Phase II clinical trial of its development program C-Cure®, designed as a novel stem cell therapy for heart failure based on breakthrough technology. [Cardio3 BioSciences Press Release]
Doctors Testing Stem Cell Spray to Heal Burns
Surgeons and doctors at the University of Utah are testing out a topical spray that utilizes a person's own stem cells to treat their wounds. [Deseret News]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Reversing EphB2 Depletion Rescues Cognitive Functions in Alzheimer Model
To determine the pathogenic importance of EphB2 depletions in Alzheimer’s disease and related models, researchers used lentiviral constructs to reduce or increase neuronal expression of EphB2 in memory centers of the mouse brain. [Nature]

Telomerase Reactivation Reverses Tissue Degeneration in Aged Telomerase-Deficient Mice
Researchers sought to determine whether entrenched multi-system degeneration in adult mice with severe telomere dysfunction can be halted or possibly reversed by reactivation of endogenous telomerase activity. [Nature]
COT Drives Resistance to RAF Inhibition Through MAP Kinase Pathway Reactivation
Results provide new insights into resistance mechanisms involving the mitogen-activated protein kinase (MAPK) pathway and articulate an integrative approach through which high-throughput functional screens may inform the development of novel therapeutic strategies. [Nature]
L1 Retrotransposition in Neurons Is Modulated by MeCP2
Researchers show that long interspersed nuclear elements-1 (L1) neuronal transcription and retrotransposition in rodents are increased in the absence of methyl-CpG-binding protein 2 (MeCP2), a protein involved in global DNA methylation and human neurodevelopmental diseases. [Nature]
Reprogramming Cellular Behavior with RNA Controllers Responsive to Endogenous Proteins
The engineering of gene networks has been limited by an inability to interface with native components. Researchers describe a class of RNA control devices that overcome these limitations by coupling increased abundance of particular proteins to targeted gene expression events through the regulation of alternative RNA splicing. [Science]
Invasive Three-Dimensional Organotypic Neoplasia from Multiple Normal Human Epithelia
Researchers used tumor-associated genetic pathways to transform primary human epithelial cells from the epidermis, oropharynx, esophagus and cervix into genetically defined tumors in a human three-dimensional tissue environment that incorporates cell-populated stroma and intact basement membrane. [Nat Med]
A Stapled p53 Helix Overcomes HDMX-Mediated Suppression of p53
Researchers report that a stapled p53 helix preferentially targets HDMX, blocks the formation of inhibitory p53-HDMX complexes, induces p53-dependent transcriptional upregulation, and thereby overcomes HDMX-mediated cancer resistance in vitro and in vivo. [Cancer Cell]
Small-Molecule Inhibition of Wnt Signaling Through Activation of Casein Kinase 1-Alpha
Findings reveal allosteric activation of casein kinase 1-alpha as an effective mechanism to inhibit Wnt signaling and highlight a new strategy for targeted therapeutics directed against the Wnt pathway. [Nat Chem Biol]
Transient Activation of c-MYC Expression Is Critical for Efficient Platelet Generation from Human Induced Pluripotent Stem Cells
Using an in vitro culture system yielding a hematopoietic niche that concentrates hematopoietic progenitors, researchers show that the pattern of c-MYC reactivation after reprogramming influences platelet generation from human induced pluripotent stem cells. [J Exp Med]
Mre11-Rad50-Xrs2 and Sae2 Promote 5’ Strand Resection of DNA Double-Strand Breaks
This work establishes the direct role of Mre11–Rad50–Xrs2 (MRX) and Sae2 in promoting the resection of 5’ strands in DNA DSB repair. [Nat Struct Mol Biol]



Sherley's Institute Asks to Support Government in Stem Cell Suit
In an ironic twist, the institute that employs James Sherley, one of two scientists who sued to block federally funded stem cell research, is weighing in on the other side. The Boston Biomedical Research Institute asked to support the government's appeal of a 23 August preliminary injunction that temporarily shut down National Institutes of Health-funded research on human embryonic stem cells. [Court of Appeals, United States]
Bioethics Panel Finalizes Advice for Synthetic Biology
A presidential bioethics commission concluded that the U.S. government should not clamp down too hard on research on synthetic biology. But the commission struggled with what to do about amateur synthetic biologists who aren't covered by current regulations. [Presidential Commission for the Study of Bioethical Issues, United States]
HHS Releases MLR Regulation
The Department of Health and Human Services (HHS) released the final rule dealing with the medical loss ratio (MLR) requirement of the healthcare reform law, which mandates the proportion of an insurer's revenue that must be spent on patient care as opposed to administrative expenses. [Department of Health and Human Services, United States]

Renewal of Charter for the Advisory Committee on Blood Safety and Availability (FR Doc. 2010-29518) [Department of Health and Human Services, United States]
Renewal of Charter for the Secretary's Advisory Committee on Human Research Protections (FR Doc. 2010-29517) [Department of Health and Human Services, United States]



Initiative Hopes to Expedite Cell-Based Treatments for Parkinson’s
A unique initiative which brings together some of the world’s leading Parkinson’s researchers aims to reduce further delays in using cells to treat Parkinson’s disease. The initiative will focus on refining cell-based therapy, which replaces the diseased cells with healthy cells. [University of Cambridge Press Release]
A New Collaboration with Tokyo Women’s Medical University
Karolinska Institutet and the Institute of Advanced Biomedical Engineering and Science, Tokyo Women´s Medical University have agreed to collaborate on education and biomedical research. [Karolinska Institutet Press Release]
Roche Obtains License for EGFR Lung Cancer Assays and Will Develop Tarceva Companion Diagnostic Test
Roche announced that it has obtained a worldwide sublicense from Genzyme Corporation to develop a diagnostic assay for the detection of Epidermal Growth-Factor Receptor (EGFR) mutations.
[Roche Press Release]
BioSante Pharmaceuticals Sells Oncolytic Virus Technology to Cold Genesys, Inc.
BioSante Pharmaceuticals, Inc. announced it sold to Cold Genesys, Inc. exclusive, worldwide rights to develop and commercialize its oncolytic virus technology. [BioSante Pharmaceuticals, Inc. Press Release]
GlaxoSmithKline and JSC Binnopharm Enter Vaccine Production Alliance in Russia
GlaxoSmithKline (GSK) and JSC Binnopharm announced an alliance to enable the local secondary manufacture of a number of GSK vaccines in Russia. [GlaxoSmithKline Press Release]
MDxHealth Licenses Methylation Technology to Takara Bio Inc. for Scientific Research Market
MDxHealth SA announced that it has granted a non-exclusive worldwide license for its patented methylation specific PCR technology to Takara Bio Inc. [MDxHealth SA Press Release]
BioTime, Inc. and the California Institute for Regenerative Medicine Sign Distribution Agreement for GMP-Compliant Human Embryonic Stem Cell Lines
BioTime, Inc. announced an agreement with the California Institute for Regenerative Medicine to make five clinical-grade human embryonic stem cell lines available to California-based researchers. [BioTime, Inc. Press Release]
Helix Therapeutics Inc. Secures Additional Funding to Advance Cutting-Edge Stem Cell Gene Correction Therapy for Genetic Diseases
Helix Therapeutics announced that Canaan Partners and Connecticut Innovations have made an investment of $2.5 million in the company. [PR Newswire]
Idenix Pharmaceuticals Announces $20 Million Milestone Payment From ViiV Healthcare for Initiation of Phase IIb Trial of '761
Idenix Pharmaceuticals, Inc. announced that the Company will receive a payment of $20 million from the ViiV Healthcare Company for the achievement of a clinical milestone relating to GSK2248761 (known as '761). [Idenix Pharmaceuticals, Inc. Press Release]
InteRNA Technologies Awarded EUR 1.3 Million Innovation Credit from Dutch Government
InteRNA Technologies B.V. announced that it was awarded an Innovation Credit of EUR 1.3 million from the Dutch government. [InteRNA Technologies B.V. Press Release]
Chemaphor Inc. Raises $192,000 in Private Placement
Chemaphor Inc. announced that it has issued a total of 1,920,000 common shares and 810,000 common share purchase warrants for gross proceeds of $192,000 through a private placement. [Chemaphor Inc. Press Release]
Tekmira Intellectual Property Portfolio Expands with Granting of Key Patents Covering LNP Manufacturing and Mitigation of siRNA Immune Stimulation
Tekmira Pharmaceuticals Corporation announced that the United States Patent & Trademark Office and the European Patent Office have issued key patents covering elements of Tekmira’s leading lipid nanoparticle (LNP) technology, which is used to deliver nucleic acid therapeutics, including small interfering RNA. [Tekmira Pharmaceuticals Corporation Press Release]
Vivalis Achieves a Significant Milestone with the Acceptance of an Investigational New Drug Filing (IND) for a Candidate Influenza Vaccine Using EB66® Cell-Based Technology
Vivalis announced that the company achieved a significant milestone under its agreement with GlaxoSmithKline following the U.S. Food and Drug Administration’s acceptance of an Investigational New Drug application for an investigational influenza vaccine produced in EB66® cells. [Vivalis Press Release]
BioCardia Announces CE Mark Approval
BioCardia, Inc. announced its receipt of CE Mark approval for its BioCardia® Helical Infusion System. [BioCardia, Inc. Press Release]
Drug Giants Turn Their Backs on RNA Interference
A once much-touted technique faces a difficult transition to the clinic. [NatureNews]


NIH Adds First Images to Major Research Database
The National Institutes of Health has expanded a genetic and clinical research database to give researchers access to the first digital study images. [National Institutes of Health, United States]
Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2010-29947)
Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2010-29749)
Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc. 2010-29748)
National Cancer Institute; Notice of Closed Meeting (FR Doc. 2010-29646)

National Cancer Institute; Notice of Closed Meeting (FR Doc. 2010-29619)

National Heart, Lung, and Blood Institute; Notice of Closed Meetings (FR Doc. 2010-29524)


December 14-15, 2010: Blood Products Advisory Committee Meeting Announcement 

Complete List of Currently Approved NDA and ANDA Application Submissions

Complete List of Currently Approved Premarket Approvals 

Complete List of Licensed Products and Establishments  

December 14, 2010: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Waivers for Conflicts of Interest



Oncologic Drugs Advisory Committee; Amendment of Notice [Docket No. FDA-2010-N-0001] 

Blood Products Advisory Committee; Notice of Meeting [Docket No. FDA-2010-N-0001]
Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Availability [Docket No. FDA-2010-D-0584]


Draft Guideline on Biosimilar Medicines Containing Monoclonal Antibodies Released for Consultation
The Agency has released the draft guideline on similar biological medicinal products containing monoclonal antibodies for a six-month public consultation period.

European Medicines Agency and European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Launch Electronic Register of Studies (E-Register)
The European Medicines Agency and the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have launched the ENCePP E-Register of Studies. This electronic register is a publicly accessible resource for the consultation of pharmaco-epidemiological and pharmacovigilance studies conducted by academic centers and other research organizations.

EVENTS (Listed by Date)

American Association for Cancer Research (AACR) Tumor Immunology – Basic and Clinical Advances
November 30-December 3, 2010
Miami, United States

Vaccines Europe 2010
December 1-2, 2010
London, United Kingdom

NEW Cell Therapy Manufacturing – Stem Cells and Immunotherapeutics
December 1-2, 2011
London, United Kingdom

2nd European Association for Cardio-Thoracic Surgery (EACTS) Meeting on Cardiac and Pulmonary Regeneration
December 3-4, 2010
Vienna, Austria

3rd Annual BioPartnering China
December 5-7, 2010
Shanghai, China

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

5th Annual Stem Cell Meeting on the Mesa
December 7, 2010
La Jolla, United States

Genesis 2010
December 9, 2010
London, United Kingdom

Safety Symposium organized by the NIH RAC and Co-hosted by CliniGene: Retroviral and Lentiviral Vectors for Long-Term Gene Correction: Clinical Challenges in Vector and Trial Design
December 9-10, 2010
Bethesda, United States

4th International Conference on the Mechanics of Biomaterials and Tissues
December 11-14, 2010
Waikoloa, Hawaii

The American Society for Cell Biology 50th Annual Meeting
December 11-15, 2010
Philadelphia, United States

NEW The 3rd Young Investigator Stem Cell Meeting
December 14, 2010
Tel Aviv, Israel

Partnering for Cures
December 14-15, 2010
New York, United States

Pharmacology in Stem Cells Research and Regenerative Medicine
December 17, 2010
London, United Kingdom

The 3rd Guangzhou International Conference on Stem Cell Biology and Regenerative Medicine
December 17-19, 2010
Guangzhou, China

Functional Consequences of Structural Variation in the Genome
January 8-13, 2011
Steamboat Springs, United States

4th Annual OneMedForum
January 11-13, 2011
San Francisco, United States

COGEM Symposium: GM Viruses as Medicine: Panacea or Pandora's Box?
January 20, 2011
Amsterdam, The Netherlands

Extracellular Matrix and Cardiovascular Remodeling
January 23-28, 2011
Tahoe City, United States

5th Annual Stem Cells and Regenerative Medicine World Congress
January 24-25, 2011
San Diego, United States

BIO Asia International Partnering Conference
January 24-25, 2011
Tokyo, Japan

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

Phacilitate 9th Annual North American Vaccine Forum
January 24-26, 2011
Washington, D.C., United States

IQPC’s 4th Biobanking Conference
January 24-26, 2011
Philadelphia, United States

Keystone Symposia: Stem Cells in Development, Tissue Homeostasis and Disease
January 30-February 4, 2011
Santa Fe, United States

16th Proteomics Symposium
February 3-6, 2011
Lorne, Australia

36th Lorne Conference on Protein Structure and Function
February 6-10, 2011
Lorne, Australia

CMC Workshop: Translating Science into Successful Regulatory Submissions
February 7-9, 2011
Washington, D.C., United States

Stem Cell Research Forum of India 2nd Annual Meeting
February 8-11, 2011
Bangalore, India

23rd Lorne Cancer Conference
February 10-12, 2011
Lorne, Australia

32nd Lorne Genome Conference
February 13-15, 2011
Lorne, Australia

BMT Tandem Meetings (ASBMT/CIBMTR)
February 17-21, 2011
Honolulu, Hawaii

1st Annual Clinical Meeting of the Cell Society
February 18-19, 2011
La Jolla, United States

SMi Stem Cells 2011 – Innovation and Commercialisation
February 23-24, 2011
London, United Kingdom

Molecular Medicine Tri-Conference: Stem Cells – Revolutionizing Regenerative Medicine and Personalized Therapy 2011
February 23-25, 2011
San Francisco, United States

Molecular Medicine Tri-Conference: Inaugural Circulating Tumor Cells for Cancer Detection, Diagnosis, Prognosis and Treatment
February 23-25, 2011
San Francisco, United States

American Association for Cancer Research (AACR) Targeting PI3K/mTOR Signaling in Cancer
February 24-27, 2011
San Francisco, United States

Annual Meeting of the International Society for Cell & Gene Therapy of Cancer (ISCGT)
February 27-March 1, 2011
Doha, Qatar

9th Annual BioPartnering North America
February 27-March 1, 2011
Vancouver, Canada

18th Conference on Retroviruses and Opportunistic Infections (CROI 2011)
February 27-March 2, 2011
Boston, United States

NEW World Cell Culture Congress 2011
February 28-March 2, 2011
Munich, Germany

6th Annual Stem Cell Summit
March 1, 2011
New York, United States

American Association for Cancer Research (AACR) Stem Cells, Development, and Cancer
March 3-6, 2011
Vancouver, Canada

Keystone Symposia: Stem Cells, Cancer and Metastasis
March 6-11, 2011
Dillon, United States

Cell Therapy Summit Europe (CTS Europe)
March 10-11, 2011
Maastricht, The Netherlands

Spring Meeting of the Dutch Society of Gene Therapy (NVGT)
March 10-11, 2011
Heeze, The Netherlands

March 13-18, 2011
Atlanta, United States

BIO-Europe Spring 2011
March 14-16, 2011
Milan, Italy

The 6th International Conference on Oncolytic Viruses as Cancer Therapeutics
March 16-19, 2011
Las Vegas, United States

15th Annual Hilton Head Workshop – Regenerative Medicine, Innovations for Clinical Applications
March 16-19, 2011
Hilton Head Island, United States

HIV Evolution, Genomics and Pathogenesis
March 20-25, 2011
Whistler, Canada

StemCONN 11
March 22, 2011
Farmington, United States

United Kingdom National Stem Cell Network 2011 Annual Scientific Conference
March 30-April 1, 2011
York, United Kingdom

10th Annual New England Science Symposium
April 1, 2011
Boston, United States

American Association for Cancer Research (AACR) 102nd Annual Meeting 2011
April 2-6, 2011
Orlando, United States

Clinical Gene Transfer: State of the Art Conference and e-Chips European Congress on Human iPS Cells
April 7-9, 2011
Paris, France

5th RNAi & miRNA World Congress
April 26-27, 2011
Boston, United States

3rd Epigenetics World Congress
April 26-27, 2011
Boston, United States

Inaugural Next-Gen Sequencing Congress
April 26-27, 2011
Boston, United States

GTCbio 2nd International Conference on Cancer Immunotherapy & Immunomonitoring
May 2-5, 2011
Budapest, Hungary

Australasian Gene Therapy Society (AGTS) 7th Meeting
May 4-6, 2011
Melbourne, Australia

BioPartnering India
May 4-6, 2011
Bangalore, India

NEW International Neural Transplantation and Repair 2011 (INTR11)
May 4-8, 2011
Clearwater Beach, United States

NEW World Stem Cells & Regenerative Medicine Congress 2011
May 9-11, 2011
London, United Kingdom

2nd European Biomarkers Summit
May 18-19, 2011
London, United Kingdom

Inaugural Theranostics for Personalised Medicine
May 18-19, 2011
London, United Kingdom

International Society for Cellular Therapy (ISCT) 17th Annual Meeting
May 18-21, 2011
Rotterdam, The Netherlands

American Society of Gene and Cell Therapy (ASGCT) 14th Annual Meeting
May 18-22, 2011
Seattle, United States

13th Annual C21 BioVentures
May 24-26, 2011
Napa, United States

Gordon Research Conference: Viruses & Cells
May 29-June 3, 2011
Lucca (Barga), Italy

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


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Lab Technologist – Tissue Culture (STEMCELL Technologies)

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