Volume 6.15 | Apr 4

Volume 6.15, April 4, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: St. Jude Study Shows Genetically Modified Natural Killer Cells Attack And Kill Leukemia Cells
Article

Story: First Demonstration of the Generation of Motor Neurons From Human Embryonic Stem Cells Reported
Article

Science


Can Stem Cells Reverse Heart-Attack Damage?
Therapy might revolutionize treatment of heart patients.
Article

Muscle-Targeted Gene Therapy Reverses Rare Muscular Dystrophy in Mice
Gene therapy that specifically targets muscle may reverse the symptoms of a rare form of musculardystrophy, according to new research in mice conducted by medical geneticists at Duke University Medical Center.
Article

Hair is Good Source of Stem Cells 
The Proceedings of the National Academy of Science study shows nerve cells can be grown from hair follicle stem cells.
Article 1, Article 2

Israeli Therapy Uses Adult Stem Cells to Treat Parkinson’s Disease
Brainstorm Cell Therapeutics has developed a novel stem cell therapy to treat Parkinson’s Disease – using a patient’s own bone marrow stem cells to produce the missing chemical that enables restoration of motor movement.
Article

Stem Cells without Embryos?
New methods of generating pluripotent cells may placate critics, but may not work, say scientists.
Article

Research on Primate Embryonic Stem Cells Is Crucial For Developing Human Therapies According to Cloning and Stem Cells
Article

Lab May Have Answer to Stem Cell Contamination
Growing cells with human protein avoids threat of animal taint.
Article

T Cell Epitope Immunotherapy Induces a CD4+ T cell Population with Regulatory Activity
Mark Larche and colleagues from Imperial College London describe a subset of cells that might be able to suppress cells that cause cat allergy.
Article

T Cell Therapy for Bronchial Asthma
Article

Blood Center Gene Therapy Researcher Awarded Grant
Various blood center research laboratories to collaborate in hemophilia gene therapy study; research may offer hope to severe hemophiliacs.
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Bromodeoxyuridine Increases Multipotency of Human Bone Marrow-derived Stem Cells
Abstract

Human Motor Neuron Differentiation from Human Embryonic Stem Cells
Abstract

Stable Transformation of CHO Cells and Human NARP Cybrids Confers Oligomycin Resistance (oli(r)) Following Transfer of a Mitochondrial DNA-Encoded oli(r) ATPase6 Gene to the Nuclear Genome: A Model System for mtDNA Gene Therapy
Abstract

Policy

Ottawa Announces $5.3 million in Annual Funding for Stem Cell Research
Article

Scientists Hoodwinking Public on Stem Cells
The Special Minister of State claimed some scientists were trying to hoodwink the public that embryos were essential for their research, when stem cells taken from adults were proving adequate.
Article

Business

BUSINESS NEWS

Cell Therapeutics Named in Securities Fraud Suits
Seattle law firm Keller Rohrback LLP has filed a securities fraud case in U.S. District Court in Seattle against Cell Therapeutics Inc. It’s one of several securities lawsuits that have been filed against the company recently.
Article

Chemicon International, Inc. Licenses Its Patented Amplifluor Technology for Cancer Diagnostics to Oncomethylome Sciences S.A.
Article

Corautus Genetics’ Phase IIb GENASIS Clinical Trial Receives Recommendation to Proceed from Data Monitoring Committee
Article

Bio-Matrix Scientific Group Evaluating CAD/CAM Designs for Its Stem Cell Instruments, Anticipating Near Term Mold Completion and 510k Testing
Article

eGene Has Been Issued U.S. Patent for ‘Multi-Color Multiplexed Analysis In a Bio-Separation System’
Article

Human Genome Sciences Begins Dosing of Patients in Trial of CCR5 mAb
Human Genome Sciences has begun dosing patients in a Phase I clinical trial to evaluate the safety, tolerability and pharmacology of CCR5 mAb in patients who are infected with HIV-1, the retrovirus that causes AIDS.
Article

ImmunoGen, Inc. Files IND for its HuC242-DM4 Targeted Anticancer Compound
ImmunoGen announces submission of Investigational New Drug application (IND) to the US Food and Drug Administration (FDA) for its huC242-DM4 targeted anticancer therapeutic.
Article

Immunomedics’ Humanized Anti-CD20 Antibody Effective in Severe Lupus
Immunomedics announced that a patient with severe resistant systemic lupus erythematosus (SLE), including the development of human antichimeric antibodies (HACA) against rituximab, responded to the Company’s new humanized anti-CD20 monoclonal antibody.
Article

The Immune Response Corporation Announces That REMUNE Has Been Selected for a New HIV Clinical Trial Sponsored by the U.S. National Institutes of Health
Article

StemCells, Inc. Issues FDA Update on Proposed Clinical Trial
StemCells announces recent, positive progress towards its goal of initiating Phase I clinical testing of its proprietary neural cell therapy product – HuCNS-SC – in Batten disease.
Article

U.S. BioDefense Files for Stem Cell Research Center of Excellence with National Institutes of Health with Research Collaborators from Los Alamos, CHOC, UCLA, and UCI and Liver Regeneration Technology from UCL Biomedica University College London
Article


MARKET REPORTS

Malachite Management has joined forces with established and reputable authors and publishers to bring you the following market reports outlining the very latest in Cell Therapy, Gene Therapy, and Immunotherapeutic approaches to Cancer. 

“Cell Therapy – Technologies, Markets, and Companies” is over 400 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the cell therapy industry worldwide.
For more information, including order forms, please see:

Cell Therapy Report Summary
Cell Therapy Sample Chapter
Cell Therapy Table of Contents Vol. 1  Vol. 2
Cell Therapy Order Form

“Gene Therapy – Technologies, Markets, and Companies” is over 500 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
For more information, including order forms, please see:

Gene Therapy Report Summary
Gene Therapy Table of Contents Vol. 1 Vol. 2
Gene Therapy Order Form

The Immunotherapy Reports cover the most recent developments in the immunotherapeutic approaches to cancer.

A Shift in Cancer Immunotherapy Strategies?
Immunotherapy Strategies Executive Summary
Immunotherapy Strategies Table of Contents

Future Perspectives in Cancer Immunotherapy
Future Perspectives Executive Summary
Future Perspectives Table of Contents

Immunotherapy Reports Order Form

NIH


NATIONAL INSTITUTES OF HEALTH

Novel Therapy Tested in Mice Could Chase Away Cat Allergies

Link

NCI Researchers Confirm the Effectiveness of Immunotherapy Approach to Treating Melanoma
Link

Seventh Annual NIH SBIR/STTR Conference
Link

CBER

Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products
Link

Meeting: Science Board to the Food and Drug Administration
Link

Workshop on Intravenous Immune Globulins in the 21st Century: Progress and Challenges in the Efficacy, Safety and Paths to Licensure
Link

ICH; Guidance for Industry: E2E Pharmacovigilance Planning
Link


Draft Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

Link

Regulatory

NEWS & UPDATES

UNITED STATES

FDA

FDA Issues Final Guidance on Pharmacogenomics Submissions
Link

FDA Reports Increase in Applications, Decrease in Approval Times for 2004
Link

Public Meeting; Combination Products and Mutually Conforming Labeling
Link

For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More Please Visit Our Regulatory Page

Meetings

These meetings have been added to the calendar this week:

Workshop on Intravenous Immune Globulins in the 21st Century: Progress and Challenges in the Efficacy, Safety and Paths to Licensure– Bethesda, MD
April 13, 2005
Link

Gene Therapy: State of the Art– London, England
April 25-26, 2005
Link

Human Embryonic Stem Cell Toolbox Workshop Sponsored by The NIH National Heart Lung & Blood Institute
October 16-20, 2005
Link

To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit Our Meetings Page

Journals

To View a List of Cell Therapy-Related Journals, Please Visit Our Journals Page
Careers

JOB POSTINGS IN CELL THERAPY NEWS ARE FREE!
For information on posting an opportunity email: [email protected]

Acting President
San Diego, California (California Institute of Regenerative Medicine)

Cellular Production Lead Technician
Seattle, WA (Fred Hutchinson Cancer Research Center)

Director of Cell Therapy
New York, NY (New York Blood Center)

Director of Research Programs 
Toronto, Ontario (Ontario Genomics Institute)

Faculty Positions in Stem Cell Research 
Ottawa, Ontario (Ottawa Health Research Institute)

Microbiologist NEW!
Rockville, MD (Center for Biologics Evaluation and Research)

Pharmacologist (enter Requisition Code 0412768)
Exton, Pennsylvania (Therakos, Inc.)

Post Doctoral Fellow (enter Requisition Code 0408577)
Somerville, New Jersey (Ethicon)

Post Doctoral or Engineer Positions 
Toronto, Ontario (Centre for Computational Biology Hospital for Sick Children)

Principal/Senior Scientist (enter Requisition Code 0408581)
Somerville, New Jersey (Ethicon)

Product Manager (Immunology)
Vancouver, BC (StemCell Technologies)

Program Support Specialist NEW!
Rockville, MD (Center for Biologics Evaluation and Research)

Project Manager (Research & Development) 
Vancouver, BC (StemCell Technologies)

Regulatory Information Specialist, OBE
Rockville, MD (Center for Biologics Evaluation and Research)

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

Scientific/Technical Officer,Stem Cell Transplant Laboratory/Haematology 
Sydney, Australia (SWAPS, Liverpool Hospital)

Scientist, Bacteriology NEW!
Potters Bar, Hertfordshire, England (National Institute for Biological Standards and Control)

Scientist (enter Requisition Code 0408593)
Somerville, New Jersey (Ethicon)

Stem Cell Specialist
Philadelphia, PA (Children’s Hospital of Philadelphia)

Quality Control Technologist
 Vancouver, BC (StemCell Technologies)

ISCT


International Society for Cellular Therapy
www.celltherapy.org

Upcoming Meetings & Conferences:

2005 Cell Therapy Audioconference Series

May 3-4, 2005 Current Good Tissue Practice. Vancouver, BC
Workshop Chairs: Janice Davis-Sproul, MAS, MT (ASCP) SBB (John Hopkins University) & John McMannis, PhD (MD Anderson Cancer Center)
Email

May 4-7th, 2005 11th Annual ISCT Meeting. Vancouver, BC
Program Themes Include: Tissue Engineering, Mesenchymal Stem Cells, Immunotherapy, & Hematopoietic Stem Cells
Email

May 4-7th, 2005 Applications of Flow Cytometry in Marrow and Stem Cell Transplantation. Vancouver, BC
Email

Profiled Journal

 


 

Join ISCT ($130) and receive the journal as a benefit of membership
http://www.celltherapy.org/mem_app.htm


Current Volume
:Volume 7, Number 1 / March 2005

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells , immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes
contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.
www.cytotherapy.com



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