Volume 6.24 | Jun 6

Volume 6.24, June 6, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Research Boosts Hope for Stem Cell Therapy: ‘Stress Testing’ Dispels Fear of Dangerous Instability

Story: Gene Therapy Corrects PKU in Mice


Stem Cell Therapy Helps Man Regain Sight
Four years ago, Greg McLaughlin couldn’t read or drive a car. Stem cell research literally changed his outlook.

Stem Cells Implanted in Brain of Patient Who Suffered a Cerebral Infarction, Argentina
Stems cells were implanted for the first time in Argentina in the brain of a patient who had suffered a Cerebral Infarction across a catheterization of the arteries.

A Boost for Broken Hearts?
The Institute of Regenerative Medicine in Barbados is convinced that stem cells from fetuses can repair cardiac damage.

Scientists Use Gene Transfer Technology and Common Virus To Block Neuropathic Pain
Remember how it felt the last time you burned your finger on a hot stove? Imagine what it’s like to have that burning pain in your hands or feet all the time and know there’s virtually nothing you can do about it.

Injection that Makes You 40% Stronger
After 15 years of research Professor Geoff Goldspink and his team are ready to trial their new gene technique on people.


Establishing a Platform for Immunotherapy: Clinical Outcome and Study of Immune Reconstitution After High-dose Chemotherapy with Progenitor Cell Support in Breast Cancer Patients

Oral Gene Therapy: A Novel Method for the Manufacture and Delivery of Protein Drugs

Stem Cell-ness: A “Magic Marker” for Cancer


Stem Cells Challenged in Brazil
Brazil’s attorney general has filed a petition with the Supreme Court to have research with embryonic stem cells declared unconstitutional.



VWR International, Inc. to Sell BioLife Products Under Exclusive Private Label Agreement

Chromos Molecular Enters Into Agreement With Pfizer
Chromos Molecular Systems Inc. announced that it has entered into a nonexclusive commercial license agreement with Pfizer Inc. under which Pfizer will have the right to use the ACE System to develop cell lines for research, development and manufacturing of Pfizer products.

Exelixis and Genentech Collaborate on Novel Therapeutics for Cancer, Inflammation, and Tissue Growth and Repair 
Exelixis,Inc. announced today that it has signed a collaboration agreement with Genentech for the discovery and development of therapeutics to target cancer, inflammatory diseases, and tissue growth and repair.

European Regulatory Committee Recommends Orphan Drug Status for GPC Biotech’s Anticancer Monoclonal Antibody 1D09C3 for Hodgkin’s Lymphoma
GPC Biotech AG today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has recommended the granting of orphan medicinal product designation for the anticancer monoclonal antibody 1D09C3 for the treatment of Hodgkin’s lymphoma.

The Immune Response Corporation Announces IR103 to be Studied in Drug-Naïve HIV  Patients
The Immune Response Corporation, a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS), announced today that a new arm of a Phase I/II clinical trial investigating IR103, the Company’s newest product candidate for the treatment of HIV, has been initiated.

Immunomedics, Inc. Initiates Two Pivotal Phase III Trials In Lupus
Immunomedics, Inc. , a leading biopharmaceutical company focused on developing monoclonal antibodies, today announced patient dosing has begun for the pivotal Phase III clinical trials to further evaluate the safety and efficacy of the Company’s lead drug candidate, epratuzumab, for the treatment of patients with systemic lupus erythematosus (SLE), known as lupus.

Introgen Therapeutics, Inc. Wins European Patent Decision On p53 Gene Therapeutic; Ruling Clears Path To Commercialization Of ADVEXIN(R) In Europe
Introgen Therapeutics, Inc. announced today that it was successful in winning the decision regarding its opposition of European Patent 0 390 323 before the European Patent Office (EPO) in which all claims directed to therapeutic applications of the p53 gene, the active component of Introgen’s ADVEXIN(R) molecular therapy, were finally revoked by the EPO’s Technical Board of Appeals.

Targeted Genetics Corporation’ Collaborators Present Preclinical Data On AAV Technology And Inflammatory Disease At The 8th Annual Meeting Of The American Society of Gene Therapy
Targeted Genetics Corporation announces that its academic collaborators will present results of preclinical studies designed to evaluate adeno-associated virus (AAV) vectors in the treatment of inflammatory disease and periodontal disease and to assess cellular vectors that impact the efficiency of AAV- mediated gene delivery.


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 Guide for Grants and Contracts – Week Of June 3, 2005


All new CBER information can be reached from the What’s New page Medical Device Notification – StemCXP Software, Version 1.0 (Beckman Coulter, Inc)

Workshop on Leukocyte Reduction of Blood and Blood Components: “An Update”

Medical Devices Regulated by CBER; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Export Certification – Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries – Update

Approved Biologics NDA and ANDA Applications – Update

Cleared Biologics 510(k) Device Applications – Update

Approved Biologics Premarket Approval (PMA) Device Applications– Update

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update


For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More, Please Visit The Regulatory Page On The Cell Therapy News Website 


This meeting has been added to the calendar this week:

AACR International Conference on Frontiers in Cancer Prevention Research. Baltimore, Maryland
October 30 – November 2

To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit The Meetings Page  On The Cell Therapy News Website


To View a List of Cell Therapy-Related Journals, Please Visit The Journals Page On The Cell Therapy News Website


For information on posting an opportunity email: [email protected]

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

Assistant Supervisor (Human Cellular Therapy) 
Rochester, Minnesota (Mayo Clinic)

Cell Processing Medical Technologists 
Oldsmar, Florida (Cryo-Cell International Inc.)

Cell Therapy Scientist 
Philadelphia, Pennsylvania (RheoGene, Inc.)

Cell Therapy Specialist 
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Cell Therapy Supervisor 
New York, New York (New York Blood Center)

Cell Therapy Technologist 
New York, New York (New York Blood Center)

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

Clinical Laboratory Scientist
Los Angeles, California (Cedars-Sinai Medical Center)

Clinical Consultant  
Deerfield, Illinois (Baxter Healthcare)

Consultant– (AABB)

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

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

Faculty Positions 
Singapore (John Hopkins Singapore)

Instrumentation Engineer II 
Gaithersburg, Maryland (Maxcyte)
Interdisciplinary Scientist (Pharmacology/Toxicology) 
Rockville, Maryland (CBER)

Laboratory Manager 
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Laboratory Supervisor (Stem Cell Lab)
Charlottesville, Virginia (University of Virginia Health System)

Lead Assessor (Part Time) 
Bethseda, Maryland (AABB)

Manager, Device Engineering
Gaithersburg, Maryland (Maxcyte)

Manager, Quality Assurance 
Gaithersburg, Maryland (Maxcyte)

Marketing Manager 
Denver, Colorado (Gambro BCT)

Medical Laboratory Technologist (Stem Cell)
Roswell Park Cancer Institute (Buffalo, New York)

Post Doctoral Fellowship 
Memphis, Tennessee (St. Jude Children’s Research Hospital)

Program Leader: Cell Biology (Professor/Associate Professor) 
Melbourne, Australia (Peter MacCallum Cancer Centre)

Quality Assurance Associate
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Quality Manager 
Sydney, Australia (Bone Marrow Transplant Network NSW)

Research Associate II 
Gaithersburg, Maryland (Maxcyte)

Scientific Director 
Boston, Massachusetts (CBR Insitute for Biomedical Research CHCT)
Scientific Review & Program Officers NEW!
San Diego, California (California Institute of Regenerative Medicine)

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

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

Senior Hospital Scientist 
Sydney, Australia (Australian Stem Cell Facility Sydney Children’s Hospital)

Senior Officer for Medical & Ethical Standards NEW!
San Diego, California (California Institute of Regenerative Medicine)

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

Stem Cell Lab Lead Technologist
Boston, Massachusetts (Beth Israel Deaconess Medical Center)

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

Stem Cell Techonologist 
Salt Lake City, Utah (University of Utah Hospital and Clinics Stem Cell Laboratory)

Supervising Medical Laboratory Technologist (Quality Assurance)
Buffalo, New York (Roswell Park Cancer Institute)

Supervising Medical Laboratory Technologist (HLA, Stem Cell, Therapeutic Apheresis) 
Buffalo, New York (Roswell Park Cancer Institute)

Supervisor Cellular Activities 
New York, New York (Memorial Sloan-Kettering Cancer Center)

Therapy Scientist
(Therapeutic Aphaeresis and Cell Therapy)
Denver, Colorado (Gambro BCT)


International Society for Cellular Therapy

Upcoming Meetings & Conferences:

2005 Cell Therapy Audioconference Series

5th Annual Somatic Cell Therapy Symposium. Bethesda, Maryland
Sept. 15-18, 2005

Profiled Journal



Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”

Join ISCT ($130) and receive the journal as a benefit of membership

Current Volume: Volume 7, Number 2 / May 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.

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