Volume 6.35 | Aug 29

Volume 6.35, August 29, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
Cell Therapy News on Facebook  Cell Therapy News on Twitter

Top Stories

Story: Immune System Finding Paves Way For Vaccine Use In Some Leukemia, Lymphoma Cancers

Story: Researchers Devise New Technique for Creating Human Stem Cells


S.Korean Scientists Clone Pigs for Cancer Cure Supplements
South Korean scientists said Wednesday that they have successfully cloned pigs that can produce a protein used as a supplement to cancer treatment.
Article 1, Article 2

First Clinical Trial of a Biologic Nanoparticle Designed to Give Back to Cancer Patients the Tumor-busting Gene They Have Lost
The phase I clinical study will enroll 20 patients with advanced solid cancers (including most common tumor types), and is the culmination of more than a decade of work by a team of researchers led by Professor Esther H. Chang, Ph.D. at the Lombardi Comprehensive Cancer Center.

Malfunctioning Bone Marrow Cells Sabotage Nerve Cells in Diabetes
Malfunctioning bone marrow cells that produce insulin appear to cause a dangerous nerve condition called neuropathy that disables many people with diabetes, said a research team led by Baylor College of Medicine in Houston.

Yerkes To Develop First Transgenic Nonhuman Primate Model For Inherited Neurodegenerative Diseases
The goal of this four-year, National Institutes of Health (NIH)-sponsored study is to develop treatment and prevention options specifically for Huntington’s disease.

Stem Cells With Heart Bypass Surgery Trial To Begin At University Of Pittsburgh
The University of Pittsburgh Medical Center (UPMC) has been granted approval by the U.S. Food and Drug Administration (FDA) to conduct a clinical trial to determine the safety and feasibility of injecting a patient’s own bone marrow-derived stem cells directly into the heart during conventional heart bypass surgery.


Adenovirus-mediated Interferon Alpha Gene Transfer Induces Regional Direct Cytotoxicity and Possible Systemic Immunity Against Pancreatic Cancer

Applications of Major Histocompatibility Complex Class I Molecules Expressed as Single Chains

Improved Stem Cell MR Detectability in Animal Models by Modification of the Inhalation Gas




Stem Cell Therapeutics And Medicon A/S Report Positive Preliminary Response From Danish Regulatory Agency For Proposed Phase I Clinical Trial And Sign Letter Of Intent To Initiate
Stem Cell Therapeutics Corp. and Medicon A/S of Birkerod, Denmark announced today they have signed a Letter of Intent (“LOI”) for SCT to retain Medicon to conduct SCT’s first Phase I clinical trial in the NTx(TM)-265 therapeutic program for the treatment of stroke.

Immunotope Vaccine to be Evaluated in Cancer Trial
Immunotope has submitted an investigational new drug application (IND) to the FDA in collaboration with Duke University to initiate a Phase I ovarian cancer clinical trial.

Firm Makes Headway in Cell Therapy
Cellerant would help fight radiation using adult stem cells, not ones taken from embryos.

Wall Street Biotech Insider Gets No. 2 Job at the FDA
Only a month ago, Dr. Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors. Now Gottlieb holds the No. 2 job at the Food and Drug Administration (FDA), the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted.

Invitrogen Corporation And The Scripps Research Institute Announce Research Collaboration
Invitrogen Corporation, a provider of essential life science technologies for disease research and drug discovery, and The Scripps Research Institute today announced a research collaboration directed towards the expression and characterization of membrane proteins.


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



NIH Guide for Grants and Contracts – Week Of August 26, 2005

Draft Guidance for Industry: Gene Therapy Clinical Trials – Observing Participants for Delayed Adverse Events

Services for the Pre-Clinical Development of Therapeutic Agents – NIH-NIAID-DMID-06-09

NIH Announces Final Ethics Rules
Ban on Outside Consulting with Industry Remains in Force


All new CBER information can be reached from the What’s New page

ICH Workshop on Oncolytic Viruses

Public Workshop – Update On: Leukocyte Reduction of Blood and Blood Components (Transcript)

2005 Meeting Schedule – Update



Definition of Primary Mode of Action of a Combination Product; Final Rule

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 



2nd Tumor Progression & Therapeutic Resistance. Boston, MA
September 18 – 20, 2005

ICH Workshop on Oncolytic Viruses. Chicago, Illinois
November 7, 2005


Emerging Cardiac Cellular Therapies: Incorporating cGMP Federal Regulations into Clinical Trials. Bethesda, MD
Co-sponsored by AABB and ISCT
September 15 – 16, 2005
This year, a Cardiac Cell Therapy Workshop has been created to precede the annual Somatic Cell Therapy Symposium. This workshop was designed to address questions related to the various cell types being used in the context of cardiac repair.

Fifth Annual Somatic Cell Therapy Symposium. Bethesda, MD
Co-sponsored by AABB, ISCT and FDA
September 16 – 18, 2005
The annual Somatic Cell Therapy Symposium is a forum provided to engage FDA and industry in an ongoing dialogue regarding the regulatory issues pertaining to somatic and other cell therapies.

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)

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)

Cord Blood Director 
Minneapolis Minnesota (The National Marrow Donor Program™)

Consultant– (AABB)

Cytotherapy Technologist Stem Cell 
New York, New York (Memorial Sloan-Kettering Cancer Center)

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

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

Instrumentation Engineer II 
Gaithersburg, Maryland (Maxcyte)
Laboratory Supervisor (Stem Cell Lab)
Charlottesville, Virginia (University of Virginia Health System)

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)

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

Research Associate II 
Gaithersburg, Maryland (Maxcyte) 
Scientific Review & Program Officers 
San Diego, California (California Institute of Regenerative Medicine)

Scientific Sales Representative
Vancouver, British Columbia (StemCell Technologies)

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

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

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

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

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

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)

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

Vice President of Manufacturing Operations
Dallas, Texas (ODC Therapy Inc.)


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 3/ July 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.

 Learn more about Cell Therapy News:  Archives  |  Events  |  Update Profile  |  Contact Us