Volume 6.30 | Jul 25

Volume 6.30, July 25, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Gene-Nanoparticle Gene Transfer Is Better Than Viral Vector Transfer System

Story: New Bone Marrow Transplantation Technique Promises Safer, More Effective Cancer Treatments


Australian Discovery Of Adult Stem Cells In The Uterus 
Monash Institute of Medical Research (MIMR) senior scientist Dr Caroline Gargett’s discovery of adult stem cells in the uterus that can be grown into bone, muscle, fat and cartilage, has been hailed as a major medical and scientific development by international reproduction experts

Discarded Foreskins Yield Stem Cells

Researchers at Toronto’s Hospital for Sick Children have found that babies’ discarded foreskins can yield stem cells, which could potentially be used to treat conditions ranging from Alzheimer’s disease to spinal cord injury.

Australia Company to Manufacture Equine Stem Cells
An Adelaide, Australia-based company has attained a license to manufacture equine stem cells in Australia.

Made More Accessible?

Monoclonal antibodies have been developed for the treatment of numerous diseases, but their manufacture is lengthy and labour intensive. A recent discovery may lead to improved production, however.

New Study Seeks Out Evidence of Stem Cells in the Heart
The traditional view holds that cardiac cells simply grow larger to accommodate the increased need, but Drs. Houser and Anversa developed a different theory – that spurred by the cardiac stem cells, cardiomyocytes actually increase in number in their response to the heart’s traumatic condition.

Evidence Boosts Stem Cells’ Promise
In a postmortem examination of a trial participant who died of an unrelated condition 11 months after receiving the therapy, the researchers found stem cells injected directly into the heart not only improved blood flow and blood-vessel formation but even grew new tissue.

Stem Cell Clue to Birth Defects
A discovery of how stem cells form the neck and shoulders could help babies born with birth defects, say international scientists.


Dendritic Cell Maturation by Innate Lymphocytes : Coordinated Stimulation of Innate and Adaptive Immunity

Induction of Cellular Immune Responses Against Carcinoembryonic Antigen in Patients with Metastatic Tumors After Vaccination with Altered Peptide Ligand-loaded Dendritic Cells

Regenerative medicine of the Pancreatic Beta Cells


EMEA Issues Guidelines on Certain Biosimilar Products
The European Medicines Agency (EMEA) recently released draft guidelines outlining specific parameters for nonclinical and clinical studies for four biosimilar products — a move that brings the agency a step closer to forming a regulatory pathway for follow-on biologics.

European Commission Adopts Report Covering Gene Patents and Stem Cells
The European Commission has adopted a second report (COM(2005)312) to the Council and European Parliament covering developments and implications of patent law in the field of biotechnology and genetic engineering. It focuses on issues in the area of patents relating to gene sequences and the patentability of inventions relating to stem cells.

ICOC Creates Governance Subcommittee, Approves Rules For Facilities Working Group: Governance Subcommittee to Focus on Strategic Plan, Bylaws and Contracts
The Independent Citizens’ Oversight Committee (ICOC) of the California Institute for Regenerative Medicine (CIRM) voted yesterday to create a new subcommittee focused on governance issues related to the CIRM and approved rules for the Facilities Working Group.



BrainStorm Cell Therapeutics Announces Adult Stem Cell Breakthrough For Neurodegenerative Diseases
BrainStorm Cell Therapeutics, today announced a breakthrough in the development of adult stem cell therapeutics for neurodegenerative diseases. The company’s scientific collaborators at Tel Aviv University, have successfully used adult stem cells to produce glial derived neurotrophic factor (GDNF).

BD(TM) PuraMatrix(TM) Synthetic Hydrogels Featured in BD Biosciences Inaugural Web Seminar Series
The seminar will focus on the use of PuraMatrix™ as a novel synthetic extracellular matrix analogue, enabling improvements across applications such as defined cell-based assays for drug discovery and stem cell research, 3-D cell culture, cellular microenvironment studies, bioproduction and tissue engineering.

Biomira Exercises Option to Acquire Stake in Australia’s Prima BioMed Ltd.
Cancer vaccine developer Biomira Inc. said Tuesday it has exercised an option to acquire a stake in Prima BioMed Ltd., an Australian biotech company, for an undisclosed price.

Cerus Corporation Appoints Dr. Joseph Eiden Vice President, Clinical Research and Medical Affairs
Cerus Corporation today announced that Dr. Joseph Eiden has joined the company as vice president, clinical research and medical affairs. Dr. Eiden will oversee the company’s clinical development efforts.

Alethia BioTherapeutics, Inc., is Issued a European Patent For Its Target Discovery Technology
Alethia BioTherapeutics, Inc., a biotechnology with innovative approaches for the treatment of cancer and related diseases, is pleased to announce the issuance of European Patent No. EP0914470, “Subtractive Amplification.”

Cytori Therapeutics Reports Adipose-Derived Stem Cells Home to, Engraft and Repair Injured Heart Muscle in Preclinical Model of Heart Attack-Like Injury
“Our results expand upon our earlier preliminary findings that ADCs may repair or minimize damage to an injured heart through multiple mechanisms, including differentiation into heart muscle and through the recruitment of oxygen to the damaged area through the induction of blood vessel growth,” said Marc H. Hedrick, M.D., President for Cytori Therapeutics.

Dendreon’s Second Randomized Phase 3 D9902A Trial Shows Provenge Extends Survival in Patients with Advanced Prostate Cancer
Dendreon Corporation today announced that the analysis of the final three-year survival data of its second Phase 3 study (D9902A) of Provenge(R), the Company’s investigational active immunotherapy for the treatment of prostate cancer, showed a survival benefit in men with advanced prostate cancer who were treated with Provenge.

Genzyme Launches Minimal Residual Disease Test for Common Leukemia
Genzyme Corporation announced today that it has launched a new test to detect very low levels of disease, also known as minimal residual disease (MRD), in patients with B-cell chronic lymphocytic leukemia (B-CLL).

Human BioSystems Successfully Transplants Kidneys Stored at Suspended Animation Temperatures
Human Biosystems announces today that it was successful in transplanting animal kidneys preserved in the Company’s proprietary “HBS Preservation Solution” after being stored in liquid Nitrogen at -196 degrees Centigrade.

Introgen’s INGN 241 Cancer Therapy Triggers Immune System to Kill Cancer Cells
Researchers at Introgen Therapeutics, Inc. and their collaborators at The University of Texas M. D. Anderson Cancer Center have published new findings on the role of IL-24 in regulating the immune system in the current online issue of the Journal of Leukocyte Biology.

Invitrogen Opens Australian cGMP Manufacturing Facility; New Operation Increases Worldwide Capacity in Serum Development Invitrogen Corporation, the leading provider of essential life science technologies for disease research and drug discovery, today announced the opening of a new cGMP bioproduction facility focused on development of safe and consistent bovine sera products and reagents used in basic research and the production of vaccines and biotherapeutic drugs for world markets. 

Xencor, Inc. Signs Collaboration with Centocor, Inc. to Improve Antibodies
Under the terms of the agreement, Xencor’s XmAb(TM) engineered antibody Fc domains will be used to create antibody drug candidates that Centocor will evaluate against an oncology target.


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 July 22, 2005

Human Pancreatic Islet Cell Resources (ICRs)(RFA-RR-05-003)


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

Research Review Subcommittee of the Blood Products Advisory Committee; Notice of Meeting

Cellular, Tissue and Gene Therapies Advisory Committee (formerly Biological Response Modifiers Advisory Committee); Notice of Meeting

Market Withdrawal of HIV-1 / HCV Assay – Procleix – Gen-Probe Inc

Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry

Substantially Equivalent 510(k) Device – LIFECODES HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB Typing Kits for use with Luminex 100 (Tepnel Lifecodes Corporation)





Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

FDA’s Regulatory Landscape for hESC Transplantation 2005 Frontiers in Human Embryonic Stem Cells Training Course

Guidance for Industry on Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability

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 



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.

This meeting was added to the calendar this week:

A Novel Peptide Hydrogel for Optimizing Cell-Based Studies (Webinar)
July 27, 2005 11:00 AM Eastern Time. 17:00 Central European Time 

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)

Biologist (Therapeutic Proteins) NEW!
Bethesda, Maryland (CBER)

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)

Clinical Trials Coordinator 
Vancouver, British Columbia (Malachite Management)

Consultant– (AABB)

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

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

Director of Scientific Business Development (Regenerative Medicine) NEW!
Cambridge, Massuchusetts/San Francisco, California (3DM PuraMatrix Hydrogels Inc.)

Instrumentation Engineer II 
Gaithersburg, Maryland (Maxcyte)
Interdisciplinary Scientist (Cellular and Gene Therapies) NEW!
Rockville, Maryland (CBER)

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

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)

Medical Officer (Clinical Evaluation and Pharmacology/Toxicology) NEW!
Rockville, Maryland (CBER)

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

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

Quality Control Technologist 
Vancouver, British Columbia (StemCell Technologies)

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)


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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