Volume 6.20 | May 9

Volume 6.20, May 9, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: BioE First to Clone and Commercialize Multipotent Stem Cell Lines Derived from Human Umbilical Cord Blood
Article

Story: Jefferson Scientists Use Tobacco Plants to Produce Monoclonal Antibodies Against Tumor Cells
Article

Science

Researchers Spur Growth of Adult Heart Muscle Cells
Howard Hughes Medical Institute researchers have induced adult heart muscle cells to proliferate in adult animals.
Article

Gene Therapy Trial Focuses on Leg Pain
A major new clinical trial could offer hope to patients with a common cause of disabling leg pain.
Article

Menopause Delay ‘A Possibility’
Early stage human eggs have been developed from stem cells for the first time, US researchers have revealed.
Article

Why Stem Cells Divide and Develop Less Vigorously as We Age
A comprehensive study from Canada’s Robarts Research Institute has pinpointed two genes that shed significant light on why stem cells divide and develop less vigorously as we age.
Article

Specific Genes Play Key Role in the of Regulation of Human-blood Stem Cells
A study published in the May issue of Developmental Cell identifies specific genes that appear to be key players in the regulation of human-blood stem cells.
Article

Stem Cell Institute Awards First Seed Grant: Twelve scientists receive $1.8 million
The Harvard Stem Cell Institute (HSCI) has selected 12 young scientists working in a wide range of research to be its first seed grant recipients.
Article 1, Article 2

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Effects of Cell-to-Collagen Ratio in Mesenchymal Stem Cell-Seeded Implants on Tendon Repair Biomechanics and Histology
Abstract

Elements of Style: Consent Form Language and the Therapeutic Misconception in Phase 1 Gene Transfer Trials
Abstract

Engineered Adipose Tissue from Human Mesenchymal Stem Cells Maintains Predefined Shape and Dimension: Implications in Soft Tissue Augmentation and Reconstruction
Abstract

Intensive Treatment and Stem Cell Transplantation in Chronic Myelogenous Leukemia: Long-term Follow-up
Abstract

Policy

Massachusetts House Approves Stem-Cell Bill
House lawmakers on Wednesday overwhelmingly approved a final version of a bill that would give scientists in the state more freedom to conduct embryonic stem cell research, despite a promised veto by Gov. Mitt Romney.
Article

Business

BUSINESS NEWS

Amgen Sued for Parkinson’s Drug
According to media reports Tuesday, two patients afflicted with Parkinson’s Disease and involved in a clinical trial for an Amgen drug treating the disease have sued Amgen over the discontinuation of the trial.
Article

CellGenix Introduces New Line of Research-grade Cytokines at ISCT 2005
CellGenix is pleased to announce at this year’s ISCT Annual Meeting the introduction of a new line of research grade cytokines for dendritic cell maturation and expansion of progenitor and hematopoietic stem cells.
Article

Dataworks Development Breaks New Ground with the Release of Freezerworks Unlimited 2.0
Article

Dendreon Announces D9901 Phase 3 Study Results for Provenge Immunotherapy to be Presented at ASCO
Article

Endocyte Moves Operations to Purdue Technology Center; Celebrates Anchor Position
Endocyte Inc. today (Thursday, April 28) held an open house to showcase its new, state-of-the-art facilities in the Purdue Research Park’s newly expanded flagship incubator.
Article

FDA Approves Baxter’s GAMMAGARD Liquid 10% for Patients with Primary Immunodeficiency Disorders
Baxter Healthcare Corporation announced today that the U. S. Food and Drug Administration (FDA) has approved GAMMAGARD ® Liquid [Immune Globulin Intravenous (Human)] (IGIV) 10% Solution for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.
Article



Genetic Mingling Mixes Human, Animal Cells
On a farm about six miles outside this gambling town, Jason Chamberlain looks over a flock of about 50 smelly sheep, many of them possessing partially human livers, hearts, brains and other organs.
Article

ImmunoGen, Inc. Announces Genentech’s Renewal of Technology Access Agreement
Article

MaxCyte Appoints Ronald Holtz and Madhusudan Peshwa to Executive Team
Article

Neurologix and Medtronic Agree to Develop Gene Therapy Infusion Catheters; Medtronic Makes a Further $2 Million Equity Investment in Neurologix
Neurologix, Inc., which through its subsidiary Neurologix Research, Inc., is engaged in the research and development of proprietary treatments for disorders of the brain and central nervous system (CNS) primarily utilizing gene therapies, announced it has entered into an agreement with Medtronic, Inc. for the joint development, manufacturing and commercialization of micro-infusion catheters designed to deliver gene therapy into the brain and central nervous system.
Article

Origen Releases New Polymer for Use in Cryogenic Preservation
Origen Biomedical announced today the release of a new polymer for cryogenic use.  A derivation of Olefins and Vinyl acetates, this material, along with FEP are the only two known polymer materials which do not exhibit a defined glass transition point down to -196C.
Article

Peter MacCallum Cancer Centre Announces Formation of Dedicated Business Unit to Manage cGMP Cell Processing Facility
The Peter MacCallum Cancer Centre and its Centre for Blood Cell Therapies (CBCT) have, for some time, been undertaking fee-based clinical trials involving cell and tissue manipulation under cGMP and regulated manufacturing conditions.
Article

PharmaFrontiers Selects INC Research as Development Partner for its Novel Multiple Sclerosis Therapy
PharmaFrontiers Corp., a biotechnology company developing autologous cellular therapies for the treatment of multiple sclerosis, congestive heart failure, and diabetes, and INC Research, Inc.(R), a global contract research organization (CRO) specialized in central nervous system (CNS), oncology, and pediatric clinical research, today announced that they have formed a strategic relationship to develop multiple sclerosis therapies.
Article

Regenetech Announces Adult Stem Cells Safe
Regenetech Inc., a Houston-based, adult-stem-cell company, said today recent studies of adult stem cells expanded with its NASA-created techniques indicate the cells do not turn cancerous.
Article

Seattle Genetics Launches Manufacturing Campaign with Albany Molecular Research
Seattle Genetics, Inc. announced today that it has entered into an agreement with Albany Molecular Research, Inc.  for cGMP manufacturing of the proprietary drug-linker system employed in its SGN-35 product candidate.
Article

Seattle Genetics Receives U.S. Patent Relating to Its Antibody-Drug Conjugate Technology
Seattle Genetics, Inc. announced today that it has received a patent issued by the U.S. Patent and Trademark Office (USPTO) relating to the company’s antibody-drug conjugate (ADC) technology. 
Article

StemCell Technologies Highlights Several New Products in 2005/2006 Catalog: New Catalog Available at ISCT 2005 Conference
Article

Velcade® (Borezomib) for Injection Receives European Marketing Authorisation for Second-line Use in Multiple Myeloma Patients
Expanded label for VELCADE®, the only approved drug therapy to offer a significant survival advantage in relapsed multiple myeloma.
Article

VIRxSYS Announces Completion of Phase I study of VRX496, Novel HIV Gene Therapy, and Plans to Initiate Phase II Study
VIRxSYS Corporation, a private biotechnology company focused on the development of gene therapy treatments for diseases such as HIV/AIDS, reports completion of the initial protocol-mandated observations in a Phase I clinical trial evaluating the safety and tolerability of the novel HIV gene therapy VRX496.
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

NIH Guide for Grants and Contracts – Week Of May 6, 2005
Link

Combination Radiation/Vaccine Therapy for Prostate Cancer May Benefit Some Patients
A pilot study of an experimental therapy for prostate cancer has found that a cancer vaccine can be safely administered to patients undergoing radiation therapy.
Link

NIH Launches Program to Coordinate Research Policies
The NIH has launched a new initiative that it hopes will lead to better coordination of federal policies governing research activities, according to a top agency official.
Link

Extension of Bioengineering Research Grant (BRG) Program Announcement (PA-02-011) (NOT-EB-05-005)
Link

CBER

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

“Processing Methods for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Public Meeting”. Rockville, Maryland, June 22-23
Link

Approved Biologics NDA and ANDA Applications – Update
Link

Cleared Biologics 510(k) Device Applications – Update
Link

Approved Biologics Premarket Approval (PMA) Device Applications– Update
Link

Recall of CPDA-1 Quadruple Blood-Pack Unit, Baxter Blood-Pack Unit (BPU) with Samplink Access Device (Baxter Healthcare Corp)
Link

Device Correction of Baxter Amicus Separator (Baxter Healthcare Corp)
Link

Recall of Sepacell PLS-5A Platelet Leukoreduction Filter with Administration Set, Platelet Bedside Filter (Baxter Healthcare Corp)
Link

Approval – Vaccinia Immune Globulin Intravenous (Human) (Cangene Corp)
Link

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

Workshop on Biological Therapeutics for Rare Plasma Protein Disorders
Link

510(k) Summary: BBCS Lab Interface Application (BBCS Lab) 5.0L (Blood Bank Computer Systems, Inc)
Link

510(k) Summary: Aldecount Progenitor Cell Enumeration Kit (Stemco Biomedical, Inc)
Link

Regulatory

NEWS & UPDATES

UNITED STATES

FDA

FDA Guidance Says Some Combo Products May Qualify for PDUFA Waiver
Combination product manufacturers can cut their application user fees by as much as 50 percent if their products qualify for the “barrier to innovation” waiver established by the Prescription Drug User Fee Act (PDUFA), according to an FDA guidance.
Link

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 

Meetings

These meetings have been added to the calendar this week:

Immunogenicity for Protein-Based Therapeutics Conference. San Francisco, California
May 23-25
Link

Workshop on Biological Therapeutics for Rare Plasma Protein Disorders
June 13 – 14, 2005
Link

Human Embryonic Stem Cells – Progress Towards Cell Therapy. Sheffield, England
July 8
Link

Cancer Vaccine Clinical Trials Workshop. Alexandria, Virginia
November 10
Link

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

Journals

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

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)

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

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

Cell Therapy Scientist NEW!
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)

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 NEW!
Singapore (John Hopkins Singapore)

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

Instrumentation Engineer II NEW!
Gaithersburg, Maryland (Maxcyte)

Lab Technician 
Sunrise, Florida (Bioheart Inc.)

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

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

Manager, Device Engineering NEW!
Gaithersburg, Maryland (Maxcyte)

Manager, Quality Assurance NEW!
Gaithersburg, Maryland (Maxcyte)

Marketing Manager 
Denver, Colorado (Gambro BCT)

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

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

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

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

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

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

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

Research Associate II NEW!
Gaithersburg, Maryland (Maxcyte)

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

Senior Scientist 
Brussels, Belgium (Beta-Cell NV)

Scientific Director NEW!
Boston, Massachusetts (CBR Insitute for Biomedical Research CHCT)

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)

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

Stem Cell Techonologist NEW!
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)

ISCT


International Society for Cellular Therapy
www.celltherapy.org

Upcoming Meetings & Conferences:

2005 Cell Therapy Audioconference Series

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

Profiled Journal

 


 


Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”

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


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.
www.cytotherapy.com



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